Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Chronic Obstructive Pulmonary Disease (COPD), COPD
Brief summary
The compound GW642444 has previously been found to be well tolerated with no significant side effects in subjects with asthma and healthy volunteers. This study will assess the safety and tolerability of GW642444 in subjects with COPD in order to obtain information to support dosing in a broader population of subjects with COPD
Detailed description
A multicentre, randomised, placebo-controlled, double-blind, 4-arm parallel-group, 2-week study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of GW642444H (100 administered once daily in the morning via DISKUS™ dry-powder inhaler) compared with SEREVENT (salmeterol) (50mcg administered twice daily via DISKUS dry-powder inhaler) and placebo in subjects with moderate COPD.
Interventions
DRUGGW642444
GW642444H
OTHERPlacebo
Placebo administered twice daily
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* females must be of non-childbearing potential * moderately severe COPD
Exclusion criteria
* Subjects with a main diagnosis of asthma * subjects with poorly controlled COPD * subjects with significant heart, renal, endocrine, psychiatric, immunological or neurological disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Up to Follow-up (17 days) | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Baseline (Day 1, pre-dose) up to Day 15 | HR was measured using 28.5 h ABPM on Day 1 (continued till Day 2), Day 7 (continued till Day 8) and Day 14 (continued till Day 15). Baseline was defined as the pre-dose weighted mean of Day 1. Weighted mean was calculated by calculating the AUC of measurements made 0-4 h post-dose on Day 1, 2, 7, 8, 14 and 15 and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the AAUCMB. |
| Change From Baseline in 0-24 h Weighted Mean HR Derived From 28.5 ABPM at Day 7 and 14 | Baseline (Day 1, pre-dose) up to Day 15 | HR was measured using 28.5 h ABPM on Day 1, Day 7 and Day 14. Baseline was defined as the pre-dose weighted mean of Day 1. Weighted mean was calculated by calculating the AUC of measurements made 0-24 h post-dose on Day 7 and 14, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the AAUCMB. |
| Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Baseline (Day 1, pre-dose) up to Day 15 | HR was measured using 28.5 h ABPM on Day 1 (continued till Day 2), Day 7 (continued till Day 8) and Day 14 (continued till Day 15). For the calculation of 0-4 h maximum change from Baseline, measurements post-dose up to 6 h (actual time) was included. Baseline was defined as the pre-dose weighted mean of Day 1. Maximum change from Baseline was calculated by subtracting the Baseline value (weighted mean pre-dose Day 1) from the maximum assessment value (during 0-4 h) of the individual post-Baseline time points. |
| Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Day 1 up to Day 15 | HR was measured using 28.5 h ABPM. Weighted mean HR at 0-4 h was obtained from measurements made over 0-4 h post-dose on Day 1, 2, 7, 8, 14 and 15. Weighted mean HR at 0-24 h was obtained from measurements made 0-24 h post-dose on Day 1, 7 and 14. Maximum HR at 0-4 h was obtained from measurements made over 0-4 h post-dose on Day 1, 2, 7, 8, 14 and 15. Baseline was defined as the pre-dose weighted mean of Day 1. |
| Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1 up to Day 14 | HR was measured using 28.5 h ABPM. The assessments were analyzed hourly as 0-1 h, 1-2 h, 2-3 h, 3-4 h, 4-5 h, 5-6 h, 6-7 h, 7-8 h, 8-9 h, 9-10 h, 10-11 h, 11-12 h, 12-13 h, 13-14 h, 14-15 h, 15-16 h, 16-17 h, 17-18 h, 18-19 h, 19-20 h, 20-21 h, 21-22 h, 22-23 h and 23-24 h at Day 1, Day 7 and Day 14. |
| Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1 up to Day 14 | HR was measured using 28.5 h ABPM. The assessments for maximum HR were analyzed hourly as 0-1 h, 1-2 h, 2-3 h, 3-4 h, 4-5 h, 5-6 h, 6-7 h, 7-8 h, 8-9 h, 9-10 h, 10-11 h, 11-12 h, 12-13 h, 13-14 h, 14-15 h, 15-16 h, 16-17 h, 17-18 h, 18-19 h, 19-20 h, 20-21 h, 21-22 h, 22-23 h and 23-24 h at Day 1, Day 7 and Day 14. |
| Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | Baseline (Day 1, pre-dose) up to Day 15 | BP was measured using 28.5 h ABPM. Weighted mean SBP and DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. Weighted mean SBP and DBP at 0-24 h post-dose was obtained on Day 1, 7 and 14. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. Baseline was defined as the weighted mean SBP and DBP on pre-dose Day 1. The weighted mean change from Baseline was the AAUCMB. Data is reported for change from Baseline in weighted mean pre-dose values at Day 7 and Day 14; change from Baseline in weighted mean over 0-4 h at Day 1, 2, 7, 8, 14 and 15; and change from Baseline in weighted mean over 0-24 h at Day 1, 7 and 14. |
| Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Baseline (Day 1, pre-dose) up to Day 15 | BP was measured using 28.5 h ABPM. Maximum SBP and minimum DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. For the calculation of 0-4 h maximum/minimum change from Baseline, measurements post-dose up to 6 h (actual time) was included. Baseline was defined as the pre-dose weighted mean of Day 1 for SBP and DBP. Maximum/minimum change from Baseline was calculated by subtracting the Baseline value (weighted mean pre-dose Day 1 for SBP and DBP) from the maximum/minimum assessment value (during 0-4 h) of the individual post-Baseline time points. |
| Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Day 1 up to Day 15 | BP was measured using 28.5 h ABPM. Weighted mean SBP and DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. Weighted mean SBP and DBP at 0-24 h post-dose was obtained on Day 1, 7 and 14. Maximum SBP and minimum DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. Baseline was defined as the pre-dose weighted mean of Day 1. |
| Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | Baseline (Day 1, pre-dose) up to Day 15 | A 12-lead ECG was recorded on Day 1, 2, 7, 8, 14 and 15 with the participant in a supine position having rested in that position for at least 5 min before each reading. A total of 3 measurements separated by at least 1 min was taken at each visit and the mean recorded. The Baseline for pre-dose QTcF and QTcB measurements was the pre-dose assessment on Day 1. Weighted mean at 0-4 h for QTcF and QTcB was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the AAUCMB. The change from Baseline in maximum QTcF and QTcB at 0-4 h was calculated by subtracting the Baseline (pre-dose Day 1) value from the individual post-Baseline values. |
| Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | Day 1 up to Day 15 | A 12-lead ECG was recorded on Day 1, 2, 7, 8, 14 and 15 with the participant in a supine position having rested in that position for at least 5 min before each reading. A total of 3 measurements separated by at least 1 min was taken at each visit and the mean recorded. The pre-dose QTcF and QTcB assessment was done at Day 1, 7 and 14. Weighted mean at 0-4 h for QTcF and QTcB at Day 1, 2, 7, 8, 14 and 15 was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The maximum QTcF and QTcB at 0-4 h was obtained at Day 1, 2, 7, 8, 14 and 15. |
| Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 1 up to Day 14 | A holter monitor is a machine that continuously records the heart's electrical activity. A 3-lead holter ECG monitoring device was used. The monitor was worn for 24 h during normal activity to record the ECG intervals. The assesmment for hourly maximums QTcF and QTcB was done on Day 1, Day 7 and Day 14. For each h of holter monitoring the maximum QTcF for that h was calculated using the maximum QT and mean HR of that given h as Maximum QT divided by (60/Mean HR)\^1/3. For each h of holter monitoring the maximum QTcB for that h was calculated using the maximum QT and mean HR of that given h as Maximum QT divided by (60/Mean HR)\^1/2. |
| Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 1 up to Day 14 | A holter monitor is a machine that continuously records the heart's electrical activity. A 3-lead holter ECG monitoring device was used. The monitor was worn for 24 h during normal activity to record the heart's rhythm. The assessment for the events of supra ventricular ectopics, ventricular ectopics and ventricular runs per 24 h was done on Day 1, Day 7 and Day 14. |
| Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Baseline (Day 1) up to Day 14 | The parameters of biochemistry with their normal range included: alanine amino transferase (\[ALT\] 0-48 international units per liter \[IU/L\]), albumin (32-50 gram \[g\]/L), alkaline phosphatase (\[ALP\] 20-125 IU/L), aspartate amino transferase (\[AST\] 0-42 IU/L), calcium (2.12-2.56 millimole \[mmol\]/L, chloride (95-108 mmol/L), creatine kinase (\[CK\] 0-235 IU/L), creatinine (44-124 micromole \[µmol\]/L), direct bilirubin (0-6 µmol/L), gamma glutamyl transferase (\[GGT\] 0-65 IU/L), glucose (3.9-6.9 mmol/L), lactate dehydrogenase (\[LDH\] 0-250 IU/L), potassium (3.5-5.3 mmol/L), sodium (135-146 mmol/L), total bilirubin (0-22 µmol/L), total protein (60-85 g/L), urea (2.5-9 mmol/L) and uric acid (250-510 µmol/L). The assessments were performed on Day 1, Day 7 and Day 14. Baseline was defined as the assessment done on Day 1. Only those parameters for which at least one value of abnormality (to low or to high) change from Baseline, relative to normal ranges were reported are summarized. |
| Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Baseline (Day 1) up to Day 14 | The parameters of biochemistry with their normal range included: basophils (0-0.2 giga cells \[GI\]/L), eosinophils (0.05-0.55 GI/L), haematocrit (0.41-0.5 ratio), hemoglobin (138-172 g/L), lymphocytes (0.85-4.1 GI/L), mean corpuscle hemoglobin (\[MCH\] 27-33 picogram \[pg\]), mean corpuscle hemoglobin concentration (\[MCHC\] 320-360 g/L), mean corpuscle volume (\[MCV\] 80-100 femtoliter \[fl\]), monocytes (0.2-1.1 GI/L), segmented neutrophils (1.8-8 GI/L), total neutrophils (1.8-8 GI/L), platelet count (130-400 GI/L), red blood cell (\[RBC\] 4.4-5.8 trillion cells \[TI\]/L) count and white blood cell (\[WBC\] 3.8-10.8 GI/L) count. The assessments were performed on Day 1, Day 7 and Day 14. Baseline was defined as the assessment done on Day 1. Only those parameters for which at least one value of abnormality (to low or to high) change from Baseline, relative to normal ranges were reported are summarized. |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Baseline (Day 1, pre-dose) up to Day 15 | FEV1 is defined as the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was assessed pre-dose at Day 1, 2, 7, 8, 14 and 15. FEV1 was assessed post-dose at Day 1, 2, 7, 8 and 14. Lung function test of FEV1 was performed at the approximately same time at each visit in the morning and highest of the 3 measurements were recorded. Baseline was defined as the assessment done on pre-dose Day 1. The change from Baseline pre-dose was calculated by subtracting the Baseline value (pre-dose Day 1) from the individual post Baseline (Day 2, 7, 8, 14 and 15) values. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean FEV1 0-4 h change from Baseline was the AAUCMB obtained at Day 1, 2, 7, 8, 14 and 15. The maximum FEV1 0-4 h change from Baseline was obtained at Day 1, Day 2, Day 7, Day 8, Day 14 and Day 15. |
| Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Day 1 up to Day 15 | FEV1 is defined as the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was assessed pre-dose and post-dose at Day 1, 2, 7, 8, 14 and 15. Lung function test of FEV1 was performed at the approximately same time at each visit in the morning and highest of the 3 measurements were recorded. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean FEV1 0-4 h and maximum FEV1 0-4 h was obtained at Day 1, 2, 7, 8, 14 and 15. |
| Change From Baseline in Pre-dose Weighted Mean Heart Rate (HR) Derived From 28.5 Hour (h) Ambulatory Blood Pressure Monitoring (ABPM) at Day 7 and 14 | Baseline (Day 1, pre-dose) up to Day 14 | HR was measured using 28.5h ABPM on Day 1, Day 7 and Day 14. Baseline was defined as the pre-dose weighted mean of Day 1. Weighted mean was calculated by calculating the area under curve (AUC) of measurements made pre-dose on each day, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the average AUC minus Baseline (AAUCMB). |
| Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Up to Follow-up (Day 17) | PEF is a measure of lung function and measures how fast a person can breathe out. It was measured using a peak flow meter by the participants and recorded on daily record cards each day in the morning and evening from Screening up to Follow-up. The morning measurements were performed prior to the participant taking the morning dose of study medication or rescue medication. The evening measurements were performed prior to the participant taking the evening dose of study medication or rescue medication. The highest of the 3 values of morning and evening PEF were recorded on the diary card. The mean of 7 days of each morning and evening measurements were reported for the Run-in Week, Week 1, Week 2 and Follow-up. |
| Mean Use of Rescue Medication Over Period | Up to Follow-up (Day 17) | Ipratropium bromide was provided as the rescue medication. The use of rescue medication was recorded by the participants on daily record cards each day in the morning and evening from Screening up to Follow-up. The mean of 7 days (puffs per 24 h) were reported for the Run-in Week, Week 1, Week 2 and Follow-up. |
| Number of Participants With Rescue Free Days | Up to Follow-up (Day 17) | Ipratropium bromide was provided as the rescue medication. The use of rescue medication was recorded by the participants on daily record cards each day in the morning and evening from Screening up to Follow-up. The percentage of rescue free days during the Run-in week, Week 1, Week 2 and Follow-up Week were assessed. Data is reported for number of participants with \< 20%, \>=20 to \<40%, \>=40 to \<60%, \>=60 to \<80% and \>=80% rescue free days. |
| Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14 | Baseline (Day 1, pre-dose) up to Day 14 | Blood samples were collected at pre-dose on Day 1, Day 7 and Day 14. Baseline was defined as the assessment done on pre-dose, Day 1. Change from Baseline was calculated by subtracting the Baseline (Day 1, pre-dose) value from the individual post Baseline (Day 7 and Day 14) values. |
| Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Baseline (Day 1, pre-dose) up to Day 15 | Blood samples were collected at pre-dose and 4 h post-dose on Day 1, Day 2, Day 7, Day 8, Day 14 and Day 15. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. Baseline was defined as the assessment on Day 1 pre-dose. The weighted mean change from Baseline was the AAUCMB. Change from Baseline in maximum glucose 0-4 h and minimum potassium 0-4 h was calculated by subtracting the Baseline (Day 1, pre-dose) value from the individual post Baseline (Day 1 to Day 15) values. |
| Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Day 1 up to Day 15 | Blood samples were collected at pre-dose and 4 h post-dose on Day 1, Day 2, Day 7, Day 8, Day 14 and Day 15. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. |
| AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) | Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC over 4 h as AUC from zero (pre-dose) to 2 h post-dose (AUC \[0-2\]), AUC from zero (pre-dose) to 4 h post-dose (AUC \[0-4\]) and AUC from zero (pre-dose) to time of last quantifiable concentration (AUC \[0-t\]) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. |
| Maximum Concentration (Cmax) of GW642444H at Day 1, 7 and 14 | Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) | Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data. |
| Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14 | Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) | Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The time at which Cmax was observed and tlast was determined directly from the raw concentration-time data. |
| AUC (0-4) of CCI2189 at Day 1, 7 and 14 | Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) | CCI2189 is a counterion of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC (0-4) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. |
| Cmax of CCI2189 at Day 1, 7 and 14 | Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) | CCI2189 is a counterion of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data. |
| AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14 | Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) | GW630200 and GSK932009 are metabolites of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC (0-4) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. |
| Cmax of GW630200 and GSK932009 at Day 1, 7 and 14 | Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) | GW630200 and GSK932009 are metabolites of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data. |
| Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14 | Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) | GW630200 and GSK932009 are metabolites of GW642444H. CCI2189 is a counterion of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The time at which Cmax was observed was determined directly from the raw concentration-time data. |
| AUC (0-4) of Salmeterol at Day 1, 7 and 14 | Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) | Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC (0-4) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. |
| Cmax of Salmeterol at Day 1, 7 and 14 | Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) | Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data. |
| Tmax of Salmeterol at Day 1, 7 and 14 | Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) | Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The time at which Cmax was observed was determined directly from the raw concentration-time data. |
| Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14 | Baseline (Day 1, pre-dose) up to Day 15 | FEV1 is defined as the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Lung function test of FEV1 was performed at the approximately same time at each visit in the morning and highest of the 3 measurements were recorded. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean FEV1 over 22-24 h was obtained at Day 1, Day 7 and Day 14 which was recorded up to Day 2, Day 8 and Day 15. Baseline was defined as the assessment on Day 1 pre-dose. Change from Baseline was calculated by subtracting the Baseline (Day 1, pre-dose) value from the individual post Baseline (Day 1, Day 7 and Day 14) values. |
Countries
Australia, Bulgaria, Germany, Netherlands, New Zealand, Romania
Participant flow
Recruitment details
The study was planned on 80 male or female participants with moderate chronic obstructive pulmonary disease (COPD), aged 40 years or older from 03 November 2006 to 10 May 2007, across 14 centers of 6 countries (10 centers in Europe, 2 centers in Australia and 2 centers in New Zealand).
Pre-assignment details
Out of 145 participants screened, 77 were screen failures and remaining 68 participants were randomized in the study to receive placebo, GW642444H (100 microgram \[mcg\] or 400 mcg once daily or Salmeterol 50 mcg twice daily (BD) via the DISKUS® dry powder inhaler (DPI).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study. | 17 |
| GW642444 100 mcg Once Daily Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study. | 16 |
| GW642444 400 mcg Once Daily Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study. | 17 |
| Salmeterol 50 mcg BD Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study. | 18 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 | 1 |
| Overall Study | Exacerbation | 0 | 0 | 0 | 1 |
| Overall Study | Hepatitis B | 1 | 0 | 0 | 0 |
| Overall Study | Other-protocol violation | 0 | 0 | 1 | 0 |
| Overall Study | PR >240 at Visit 3 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | Salmeterol 50 mcg BD | GW642444 400 mcg Once Daily | GW642444 100 mcg Once Daily |
|---|---|---|---|---|---|
| Age, Continuous | 61.4 Years STANDARD_DEVIATION 8.79 | 63.4 Years STANDARD_DEVIATION 8.86 | 60.2 Years STANDARD_DEVIATION 7.37 | 66.6 Years STANDARD_DEVIATION 9.16 | 65.8 Years STANDARD_DEVIATION 9.06 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 66 Participants | 18 Participants | 17 Participants | 15 Participants |
| Sex: Female, Male Female | 4 Participants | 24 Participants | 9 Participants | 5 Participants | 6 Participants |
| Sex: Female, Male Male | 13 Participants | 44 Participants | 9 Participants | 12 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 16 | 0 / 17 | 0 / 18 |
| other Total, other adverse events | 4 / 17 | 5 / 16 | 7 / 17 | 5 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 | 1 / 17 | 1 / 18 |
Outcome results
Primary
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Time frame: Up to Follow-up (17 days)
Population: Safety Population comprised of all participants who were randomized and received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Any AE | 4 Participants |
| Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Any SAE | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Any SAE | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Any AE | 5 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Any AE | 7 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Any SAE | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Any AE | 6 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Any SAE | 1 Participants |
Secondary
AUC (0-4) of CCI2189 at Day 1, 7 and 14
CCI2189 is a counterion of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC (0-4) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.
Time frame: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Population: PK Concentration Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | AUC (0-4) of CCI2189 at Day 1, 7 and 14 | Day 1 | 11.779 Nanogram (ng)*h/mL | Geometric Coefficient of Variation 34.1 |
| Placebo | AUC (0-4) of CCI2189 at Day 1, 7 and 14 | Day 7 | 12.155 Nanogram (ng)*h/mL | Geometric Coefficient of Variation 33.83 |
| Placebo | AUC (0-4) of CCI2189 at Day 1, 7 and 14 | Day 14 | 13.683 Nanogram (ng)*h/mL | Geometric Coefficient of Variation 34.35 |
| GW642444 100 mcg Once Daily | AUC (0-4) of CCI2189 at Day 1, 7 and 14 | Day 1 | 45.664 Nanogram (ng)*h/mL | Geometric Coefficient of Variation 25.35 |
| GW642444 100 mcg Once Daily | AUC (0-4) of CCI2189 at Day 1, 7 and 14 | Day 7 | 52.866 Nanogram (ng)*h/mL | Geometric Coefficient of Variation 41.09 |
| GW642444 100 mcg Once Daily | AUC (0-4) of CCI2189 at Day 1, 7 and 14 | Day 14 | 48.348 Nanogram (ng)*h/mL | Geometric Coefficient of Variation 36.69 |
Secondary
AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14
GW630200 and GSK932009 are metabolites of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC (0-4) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.
Time frame: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Population: PK Concentration Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14 | GW630200, Day 14 | NA pg*h/mL | — |
| Placebo | AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14 | GSK932009, Day 7 | 897.695 pg*h/mL | — |
| Placebo | AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14 | GW630200, Day 7 | NA pg*h/mL | — |
| Placebo | AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14 | GSK932009, Day 14 | 797.075 pg*h/mL | — |
| Placebo | AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14 | GW630200, Day 1 | NA pg*h/mL | — |
| GW642444 100 mcg Once Daily | AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14 | GSK932009, Day 7 | 1866.738 pg*h/mL | Geometric Coefficient of Variation 58.04 |
| GW642444 100 mcg Once Daily | AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14 | GSK932009, Day 14 | 1527.671 pg*h/mL | Geometric Coefficient of Variation 20.22 |
| GW642444 100 mcg Once Daily | AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14 | GW630200, Day 1 | NA pg*h/mL | — |
| GW642444 100 mcg Once Daily | AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14 | GW630200, Day 7 | NA pg*h/mL | — |
| GW642444 100 mcg Once Daily | AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14 | GW630200, Day 14 | NA pg*h/mL | — |
| GW642444 100 mcg Once Daily | AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14 | GSK932009, Day 1 | 1222.771 pg*h/mL | Geometric Coefficient of Variation 19.18 |
Secondary
AUC (0-4) of Salmeterol at Day 1, 7 and 14
Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC (0-4) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.
Time frame: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Population: PK Concentration Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | AUC (0-4) of Salmeterol at Day 1, 7 and 14 | Day 1 | 225.334 pg*h/mL | Geometric Coefficient of Variation 14.83 |
| Placebo | AUC (0-4) of Salmeterol at Day 1, 7 and 14 | Day 7 | 226.708 pg*h/mL | Geometric Coefficient of Variation 34.42 |
| Placebo | AUC (0-4) of Salmeterol at Day 1, 7 and 14 | Day 14 | 178.656 pg*h/mL | Geometric Coefficient of Variation 33.47 |
Secondary
AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14
Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC over 4 h as AUC from zero (pre-dose) to 2 h post-dose (AUC \[0-2\]), AUC from zero (pre-dose) to 4 h post-dose (AUC \[0-4\]) and AUC from zero (pre-dose) to time of last quantifiable concentration (AUC \[0-t\]) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.
Time frame: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Population: Pharmacokinetic (PK) Concentration Population comprised of those participants in the Safety Population for whom a PK sample was obtained and analyzed. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | AUC (0-2), Day 7 | 164.374 Picogram (pg)*h/mL | Geometric Coefficient of Variation 57.3 |
| Placebo | AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | AUC (0-4), Day 14 | 300.921 Picogram (pg)*h/mL | Geometric Coefficient of Variation 40.05 |
| Placebo | AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | AUC (0-4), Day 1 | 277.582 Picogram (pg)*h/mL | Geometric Coefficient of Variation 14.92 |
| Placebo | AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | AUC (0-t), Day 1 | 192.799 Picogram (pg)*h/mL | Geometric Coefficient of Variation 51.42 |
| Placebo | AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | AUC (0-2), Day 14 | 166.055 Picogram (pg)*h/mL | Geometric Coefficient of Variation 40.98 |
| Placebo | AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | AUC (0-t), Day 7 | 212.547 Picogram (pg)*h/mL | Geometric Coefficient of Variation 86.45 |
| Placebo | AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | AUC (0-4), Day 7 | 412.496 Picogram (pg)*h/mL | Geometric Coefficient of Variation 31.95 |
| Placebo | AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | AUC (0-t), Day 14 | 275.621 Picogram (pg)*h/mL | Geometric Coefficient of Variation 49.02 |
| Placebo | AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | AUC (0-2), Day 1 | 151.067 Picogram (pg)*h/mL | Geometric Coefficient of Variation 39.92 |
| GW642444 100 mcg Once Daily | AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | AUC (0-t), Day 14 | 736.842 Picogram (pg)*h/mL | Geometric Coefficient of Variation 40.06 |
| GW642444 100 mcg Once Daily | AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | AUC (0-2), Day 1 | NA Picogram (pg)*h/mL | — |
| GW642444 100 mcg Once Daily | AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | AUC (0-2), Day 7 | NA Picogram (pg)*h/mL | — |
| GW642444 100 mcg Once Daily | AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | AUC (0-2), Day 14 | NA Picogram (pg)*h/mL | — |
| GW642444 100 mcg Once Daily | AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | AUC (0-4), Day 1 | 699.719 Picogram (pg)*h/mL | Geometric Coefficient of Variation 60.5 |
| GW642444 100 mcg Once Daily | AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | AUC (0-4), Day 7 | 945.893 Picogram (pg)*h/mL | Geometric Coefficient of Variation 58.35 |
| GW642444 100 mcg Once Daily | AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | AUC (0-4), Day 14 | 772.694 Picogram (pg)*h/mL | Geometric Coefficient of Variation 35.59 |
| GW642444 100 mcg Once Daily | AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | AUC (0-t), Day 1 | 702.937 Picogram (pg)*h/mL | Geometric Coefficient of Variation 60.22 |
| GW642444 100 mcg Once Daily | AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14 | AUC (0-t), Day 7 | 840.634 Picogram (pg)*h/mL | Geometric Coefficient of Variation 63.5 |
Secondary
Change From Baseline in 0-24 h Weighted Mean HR Derived From 28.5 ABPM at Day 7 and 14
HR was measured using 28.5 h ABPM on Day 1, Day 7 and Day 14. Baseline was defined as the pre-dose weighted mean of Day 1. Weighted mean was calculated by calculating the AUC of measurements made 0-24 h post-dose on Day 7 and 14, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the AAUCMB.
Time frame: Baseline (Day 1, pre-dose) up to Day 15
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 0-24 h Weighted Mean HR Derived From 28.5 ABPM at Day 7 and 14 | Day 7 | 6.50 bpm | Standard Deviation 6.696 |
| Placebo | Change From Baseline in 0-24 h Weighted Mean HR Derived From 28.5 ABPM at Day 7 and 14 | Day 14 | 2.77 bpm | Standard Deviation 7.495 |
| GW642444 100 mcg Once Daily | Change From Baseline in 0-24 h Weighted Mean HR Derived From 28.5 ABPM at Day 7 and 14 | Day 14 | 1.84 bpm | Standard Deviation 7.389 |
| GW642444 100 mcg Once Daily | Change From Baseline in 0-24 h Weighted Mean HR Derived From 28.5 ABPM at Day 7 and 14 | Day 7 | 3.07 bpm | Standard Deviation 7.261 |
| GW642444 400 mcg Once Daily | Change From Baseline in 0-24 h Weighted Mean HR Derived From 28.5 ABPM at Day 7 and 14 | Day 7 | 7.16 bpm | Standard Deviation 6.567 |
| GW642444 400 mcg Once Daily | Change From Baseline in 0-24 h Weighted Mean HR Derived From 28.5 ABPM at Day 7 and 14 | Day 14 | 9.23 bpm | Standard Deviation 8.173 |
| Salmeterol 50 mcg BD | Change From Baseline in 0-24 h Weighted Mean HR Derived From 28.5 ABPM at Day 7 and 14 | Day 14 | 5.87 bpm | Standard Deviation 6.42 |
| Salmeterol 50 mcg BD | Change From Baseline in 0-24 h Weighted Mean HR Derived From 28.5 ABPM at Day 7 and 14 | Day 7 | 6.47 bpm | Standard Deviation 6.885 |
Secondary
Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15
HR was measured using 28.5 h ABPM on Day 1 (continued till Day 2), Day 7 (continued till Day 8) and Day 14 (continued till Day 15). Baseline was defined as the pre-dose weighted mean of Day 1. Weighted mean was calculated by calculating the AUC of measurements made 0-4 h post-dose on Day 1, 2, 7, 8, 14 and 15 and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the AAUCMB.
Time frame: Baseline (Day 1, pre-dose) up to Day 15
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 1 | 2.14 bpm | Standard Error 2.134 |
| Placebo | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 2 | 1.01 bpm | Standard Error 2.208 |
| Placebo | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 7 | 8.21 bpm | Standard Error 2.357 |
| Placebo | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 8 | 1.11 bpm | Standard Error 2.341 |
| Placebo | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 14 | 3.64 bpm | Standard Error 2.307 |
| Placebo | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 15 | 2.17 bpm | Standard Error 2.46 |
| GW642444 100 mcg Once Daily | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 15 | 1.04 bpm | Standard Error 2.138 |
| GW642444 100 mcg Once Daily | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 8 | 1.27 bpm | Standard Error 2.046 |
| GW642444 100 mcg Once Daily | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 1 | 4.25 bpm | Standard Error 1.848 |
| GW642444 100 mcg Once Daily | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 7 | 3.95 bpm | Standard Error 2.051 |
| GW642444 100 mcg Once Daily | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 2 | 0.63 bpm | Standard Error 1.838 |
| GW642444 100 mcg Once Daily | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 14 | 2.54 bpm | Standard Error 2.037 |
| GW642444 400 mcg Once Daily | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 2 | 5.37 bpm | Standard Error 1.987 |
| GW642444 400 mcg Once Daily | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 7 | 7.76 bpm | Standard Error 2.403 |
| GW642444 400 mcg Once Daily | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 8 | 9.41 bpm | Standard Error 2.377 |
| GW642444 400 mcg Once Daily | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 15 | 5.76 bpm | Standard Error 2.666 |
| GW642444 400 mcg Once Daily | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 14 | 10.42 bpm | Standard Error 2.528 |
| GW642444 400 mcg Once Daily | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 1 | 7.47 bpm | Standard Error 1.993 |
| Salmeterol 50 mcg BD | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 14 | 6.92 bpm | Standard Error 2.476 |
| Salmeterol 50 mcg BD | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 15 | 4.28 bpm | Standard Error 2.44 |
| Salmeterol 50 mcg BD | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 2 | 5.61 bpm | Standard Error 2.138 |
| Salmeterol 50 mcg BD | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 8 | 4.94 bpm | Standard Error 2.317 |
| Salmeterol 50 mcg BD | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 1 | 4.63 bpm | Standard Error 2.02 |
| Salmeterol 50 mcg BD | Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 7 | 6.75 bpm | Standard Error 2.324 |
Comparison: Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 1.95% CI: [-3.48, 7.7]
Comparison: Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 1.95% CI: [-0.41, 11.07]
Comparison: Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 1.95% CI: [-3.35, 8.33]
Comparison: Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 2.95% CI: [-6.11, 5.36]
Comparison: Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 2.95% CI: [-1.57, 10.29]
Comparison: Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 2.95% CI: [-1.45, 10.65]
Comparison: Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 7.95% CI: [-10.44, 1.93]
Comparison: Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 7.95% CI: [-7.22, 6.32]
Comparison: Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 7.95% CI: [-8.25, 5.33]
Comparison: Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 8.95% CI: [-5.98, 6.29]
Comparison: Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 8.95% CI: [1.52, 15.08]
Comparison: Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 8.95% CI: [-2.85, 10.5]
Comparison: Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 14.95% CI: [-7.16, 4.97]
Comparison: Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 14.95% CI: [-0.11, 13.66]
Comparison: Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 14.95% CI: [-3.58, 10.15]
Comparison: Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 15.95% CI: [-7.64, 5.4]
Comparison: Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 15.95% CI: [-3.71, 10.89]
Comparison: Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 15.95% CI: [-4.96, 9.18]
Secondary
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time
FEV1 is defined as the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was assessed pre-dose at Day 1, 2, 7, 8, 14 and 15. FEV1 was assessed post-dose at Day 1, 2, 7, 8 and 14. Lung function test of FEV1 was performed at the approximately same time at each visit in the morning and highest of the 3 measurements were recorded. Baseline was defined as the assessment done on pre-dose Day 1. The change from Baseline pre-dose was calculated by subtracting the Baseline value (pre-dose Day 1) from the individual post Baseline (Day 2, 7, 8, 14 and 15) values. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean FEV1 0-4 h change from Baseline was the AAUCMB obtained at Day 1, 2, 7, 8, 14 and 15. The maximum FEV1 0-4 h change from Baseline was obtained at Day 1, Day 2, Day 7, Day 8, Day 14 and Day 15.
Time frame: Baseline (Day 1, pre-dose) up to Day 15
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 1 | 0.125 Litres (L) | Standard Deviation 0.1348 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Day 14, Pre-dose | -0.006 Litres (L) | Standard Deviation 0.2975 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 8 | 0.0563 Litres (L) | Standard Deviation 0.25677 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Day 7, Pre-dose | -0.019 Litres (L) | Standard Deviation 0.3068 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 2 | 0.152 Litres (L) | Standard Deviation 0.1888 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 15 | 0.0339 Litres (L) | Standard Deviation 0.25474 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 7 | 0.0480 Litres (L) | Standard Deviation 0.24623 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 1 | 0.0513 Litres (L) | Standard Deviation 0.1122 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 7 | 0.137 Litres (L) | Standard Deviation 0.2752 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 14 | 0.093 Litres (L) | Standard Deviation 0.2785 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 14 | 0.0557 Litres (L) | Standard Deviation 0.27371 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 15 | 0.121 Litres (L) | Standard Deviation 0.25 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 8 | 0.133 Litres (L) | Standard Deviation 0.2888 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 2 | 0.0609 Litres (L) | Standard Deviation 0.17522 |
| GW642444 100 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 8 | 0.277 Litres (L) | Standard Deviation 0.115 |
| GW642444 100 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 14 | 0.227 Litres (L) | Standard Deviation 0.1391 |
| GW642444 100 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Day 7, Pre-dose | 0.139 Litres (L) | Standard Deviation 0.1159 |
| GW642444 100 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 15 | 0.245 Litres (L) | Standard Deviation 0.1445 |
| GW642444 100 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 2 | 0.2427 Litres (L) | Standard Deviation 0.11735 |
| GW642444 100 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 15 | 0.2096 Litres (L) | Standard Deviation 0.10678 |
| GW642444 100 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 8 | 0.2313 Litres (L) | Standard Deviation 0.12148 |
| GW642444 100 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 1 | 0.241 Litres (L) | Standard Deviation 0.1191 |
| GW642444 100 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 7 | 0.2001 Litres (L) | Standard Deviation 0.12189 |
| GW642444 100 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 1 | 0.1794 Litres (L) | Standard Deviation 0.10171 |
| GW642444 100 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 2 | 0.285 Litres (L) | Standard Deviation 0.1254 |
| GW642444 100 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 7 | 0.251 Litres (L) | Standard Deviation 0.1196 |
| GW642444 100 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Day 14, Pre-dose | 0.155 Litres (L) | Standard Deviation 0.1449 |
| GW642444 100 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 14 | 0.1899 Litres (L) | Standard Deviation 0.13425 |
| GW642444 400 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 1 | 0.2099 Litres (L) | Standard Deviation 0.14168 |
| GW642444 400 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 8 | 0.2419 Litres (L) | Standard Deviation 0.17906 |
| GW642444 400 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 14 | 0.2798 Litres (L) | Standard Deviation 0.25865 |
| GW642444 400 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 15 | 0.1973 Litres (L) | Standard Deviation 0.16988 |
| GW642444 400 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 1 | 0.276 Litres (L) | Standard Deviation 0.1587 |
| GW642444 400 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 2 | 0.356 Litres (L) | Standard Deviation 0.1853 |
| GW642444 400 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 7 | 0.317 Litres (L) | Standard Deviation 0.208 |
| GW642444 400 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 8 | 0.295 Litres (L) | Standard Deviation 0.1852 |
| GW642444 400 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 14 | 0.332 Litres (L) | Standard Deviation 0.2697 |
| GW642444 400 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 15 | 0.289 Litres (L) | Standard Deviation 0.1721 |
| GW642444 400 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Day 7, Pre-dose | 0.149 Litres (L) | Standard Deviation 0.1934 |
| GW642444 400 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Day 14, Pre-dose | 0.183 Litres (L) | Standard Deviation 0.2502 |
| GW642444 400 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 7 | 0.2463 Litres (L) | Standard Deviation 0.19308 |
| GW642444 400 mcg Once Daily | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 2 | 0.2890 Litres (L) | Standard Deviation 0.17558 |
| Salmeterol 50 mcg BD | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 8 | 0.224 Litres (L) | Standard Deviation 0.2524 |
| Salmeterol 50 mcg BD | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 7 | 0.283 Litres (L) | Standard Deviation 0.2459 |
| Salmeterol 50 mcg BD | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 2 | 0.1829 Litres (L) | Standard Deviation 0.26427 |
| Salmeterol 50 mcg BD | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Day 14, Pre-dose | 0.055 Litres (L) | Standard Deviation 0.2349 |
| Salmeterol 50 mcg BD | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 2 | 0.264 Litres (L) | Standard Deviation 0.2887 |
| Salmeterol 50 mcg BD | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 1 | 0.272 Litres (L) | Standard Deviation 0.15 |
| Salmeterol 50 mcg BD | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 8 | 0.1542 Litres (L) | Standard Deviation 0.26356 |
| Salmeterol 50 mcg BD | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 1 | 0.2012 Litres (L) | Standard Deviation 0.12209 |
| Salmeterol 50 mcg BD | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 15 | 0.1938 Litres (L) | Standard Deviation 0.28321 |
| Salmeterol 50 mcg BD | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 14 | 0.1290 Litres (L) | Standard Deviation 0.29444 |
| Salmeterol 50 mcg BD | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 15 | 0.283 Litres (L) | Standard Deviation 0.2909 |
| Salmeterol 50 mcg BD | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Maximum 0-4 h, Day 14 | 0.191 Litres (L) | Standard Deviation 0.2881 |
| Salmeterol 50 mcg BD | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Weighted mean 0-4 h, Day 7 | 0.2195 Litres (L) | Standard Deviation 0.23573 |
| Salmeterol 50 mcg BD | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time | Day 7, Pre-dose | 0.181 Litres (L) | Standard Deviation 0.2584 |
Secondary
Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15
HR was measured using 28.5 h ABPM on Day 1 (continued till Day 2), Day 7 (continued till Day 8) and Day 14 (continued till Day 15). For the calculation of 0-4 h maximum change from Baseline, measurements post-dose up to 6 h (actual time) was included. Baseline was defined as the pre-dose weighted mean of Day 1. Maximum change from Baseline was calculated by subtracting the Baseline value (weighted mean pre-dose Day 1) from the maximum assessment value (during 0-4 h) of the individual post-Baseline time points.
Time frame: Baseline (Day 1, pre-dose) up to Day 15
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 1 | 20.6 bpm | Standard Error 3.71 |
| Placebo | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 2 | 9.7 bpm | Standard Error 3.17 |
| Placebo | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 7 | 26.8 bpm | Standard Error 4.21 |
| Placebo | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 8 | 9.0 bpm | Standard Error 2.85 |
| Placebo | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 14 | 26.1 bpm | Standard Error 3.73 |
| Placebo | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 15 | 10.2 bpm | Standard Error 3.04 |
| GW642444 100 mcg Once Daily | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 15 | 10.5 bpm | Standard Error 2.65 |
| GW642444 100 mcg Once Daily | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 8 | 12.4 bpm | Standard Error 2.49 |
| GW642444 100 mcg Once Daily | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 1 | 22.7 bpm | Standard Error 3.35 |
| GW642444 100 mcg Once Daily | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 7 | 21.9 bpm | Standard Error 3.68 |
| GW642444 100 mcg Once Daily | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 2 | 11.9 bpm | Standard Error 2.66 |
| GW642444 100 mcg Once Daily | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 14 | 19.0 bpm | Standard Error 3.25 |
| GW642444 400 mcg Once Daily | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 2 | 15.5 bpm | Standard Error 2.88 |
| GW642444 400 mcg Once Daily | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 7 | 25.0 bpm | Standard Error 4.37 |
| GW642444 400 mcg Once Daily | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 8 | 19.8 bpm | Standard Error 2.96 |
| GW642444 400 mcg Once Daily | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 15 | 17.0 bpm | Standard Error 3.27 |
| GW642444 400 mcg Once Daily | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 14 | 31.5 bpm | Standard Error 4.29 |
| GW642444 400 mcg Once Daily | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 1 | 23.5 bpm | Standard Error 3.61 |
| Salmeterol 50 mcg BD | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 14 | 23.2 bpm | Standard Error 3.86 |
| Salmeterol 50 mcg BD | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 15 | 14.6 bpm | Standard Error 3.13 |
| Salmeterol 50 mcg BD | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 2 | 11.3 bpm | Standard Error 2.9 |
| Salmeterol 50 mcg BD | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 8 | 12.1 bpm | Standard Error 2.95 |
| Salmeterol 50 mcg BD | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 1 | 20.5 bpm | Standard Error 3.51 |
| Salmeterol 50 mcg BD | Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15 | Day 7 | 22.0 bpm | Standard Error 4.36 |
Comparison: Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 1.95% CI: [-7.7, 12]
Comparison: Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 1.95% CI: [-7.2, 13.1]
Comparison: Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 1.95% CI: [-10.2, 10.1]
Comparison: Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 2.95% CI: [-6.1, 10.4]
Comparison: Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 2.95% CI: [-2.8, 14.3]
Comparison: Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 2.95% CI: [-6.9, 10.1]
Comparison: Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 7.95% CI: [-16.1, 6.2]
Comparison: Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 7.95% CI: [-14, 10.2]
Comparison: Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 7.95% CI: [-17.1, 7.5]
Comparison: Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 8.95% CI: [-4.1, 10.9]
Comparison: Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 8.95% CI: [2.6, 19]
Comparison: Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 8.95% CI: [-5.2, 11.4]
Comparison: Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 14.95% CI: [-17, 2.7]
Comparison: Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 14.95% CI: [-6, 16.8]
Comparison: Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 14.95% CI: [-13.8, 8]
Comparison: Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 15.95% CI: [-7.8, 8.3]
Comparison: Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 15.95% CI: [-2.1, 15.6]
Comparison: Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 15.95% CI: [-4.5, 13.3]
Secondary
Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time
BP was measured using 28.5 h ABPM. Maximum SBP and minimum DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. For the calculation of 0-4 h maximum/minimum change from Baseline, measurements post-dose up to 6 h (actual time) was included. Baseline was defined as the pre-dose weighted mean of Day 1 for SBP and DBP. Maximum/minimum change from Baseline was calculated by subtracting the Baseline value (weighted mean pre-dose Day 1 for SBP and DBP) from the maximum/minimum assessment value (during 0-4 h) of the individual post-Baseline time points.
Time frame: Baseline (Day 1, pre-dose) up to Day 15
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 8 | -8.0 mmHg | Standard Deviation 9.67 |
| Placebo | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 15 | -10.2 mmHg | Standard Deviation 6.95 |
| Placebo | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 2 | -8.8 mmHg | Standard Deviation 7.83 |
| Placebo | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 1 | 11.2 mmHg | Standard Deviation 9.46 |
| Placebo | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 7 | -9.3 mmHg | Standard Deviation 7.84 |
| Placebo | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 7 | 6.9 mmHg | Standard Deviation 10.06 |
| Placebo | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 8 | 2.1 mmHg | Standard Deviation 11.92 |
| Placebo | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 2 | 2.8 mmHg | Standard Deviation 14.31 |
| Placebo | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 14 | -17.0 mmHg | Standard Deviation 12.93 |
| Placebo | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 14 | 9.1 mmHg | Standard Deviation 10.25 |
| Placebo | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 15 | 5.7 mmHg | Standard Deviation 15.38 |
| Placebo | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 1 | -8.3 mmHg | Standard Deviation 5.79 |
| GW642444 100 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 2 | 2.8 mmHg | Standard Deviation 12.34 |
| GW642444 100 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 1 | -12.7 mmHg | Standard Deviation 7.93 |
| GW642444 100 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 8 | 4.2 mmHg | Standard Deviation 15.2 |
| GW642444 100 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 7 | -15.4 mmHg | Standard Deviation 9.69 |
| GW642444 100 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 8 | -13.4 mmHg | Standard Deviation 9.22 |
| GW642444 100 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 2 | -14.0 mmHg | Standard Deviation 9.59 |
| GW642444 100 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 1 | 11.8 mmHg | Standard Deviation 6.77 |
| GW642444 100 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 15 | -2.5 mmHg | Standard Deviation 13.39 |
| GW642444 100 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 14 | 9.4 mmHg | Standard Deviation 12.89 |
| GW642444 100 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 7 | 8.8 mmHg | Standard Deviation 13.91 |
| GW642444 100 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 15 | -12.2 mmHg | Standard Deviation 7.13 |
| GW642444 100 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 14 | -15.8 mmHg | Standard Deviation 9.62 |
| GW642444 400 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 2 | -12.5 mmHg | Standard Deviation 7.21 |
| GW642444 400 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 1 | 14.5 mmHg | Standard Deviation 11.26 |
| GW642444 400 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 2 | 10.2 mmHg | Standard Deviation 11.49 |
| GW642444 400 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 7 | 14.5 mmHg | Standard Deviation 8.55 |
| GW642444 400 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 8 | 7.2 mmHg | Standard Deviation 17.17 |
| GW642444 400 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 14 | 8.1 mmHg | Standard Deviation 9.44 |
| GW642444 400 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 15 | 3.3 mmHg | Standard Deviation 12.11 |
| GW642444 400 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 1 | -11.5 mmHg | Standard Deviation 9.07 |
| GW642444 400 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 7 | -12.2 mmHg | Standard Deviation 8.6 |
| GW642444 400 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 8 | -10.4 mmHg | Standard Deviation 8.31 |
| GW642444 400 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 14 | -16.5 mmHg | Standard Deviation 12.85 |
| GW642444 400 mcg Once Daily | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 15 | -14.3 mmHg | Standard Deviation 12.37 |
| Salmeterol 50 mcg BD | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 15 | -3.3 mmHg | Standard Deviation 12.07 |
| Salmeterol 50 mcg BD | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 14 | 2.9 mmHg | Standard Deviation 14.52 |
| Salmeterol 50 mcg BD | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 1 | 9.3 mmHg | Standard Deviation 9.56 |
| Salmeterol 50 mcg BD | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 8 | -19.2 mmHg | Standard Deviation 11.9 |
| Salmeterol 50 mcg BD | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 8 | -1.2 mmHg | Standard Deviation 16.82 |
| Salmeterol 50 mcg BD | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 7 | 2.8 mmHg | Standard Deviation 13.8 |
| Salmeterol 50 mcg BD | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 15 | -17.3 mmHg | Standard Deviation 12.12 |
| Salmeterol 50 mcg BD | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 14 | -14.3 mmHg | Standard Deviation 10.72 |
| Salmeterol 50 mcg BD | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 2 | -15.0 mmHg | Standard Deviation 5.19 |
| Salmeterol 50 mcg BD | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 1 | -14.5 mmHg | Standard Deviation 4.88 |
| Salmeterol 50 mcg BD | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Maximum SBP, Day 2 | 4.4 mmHg | Standard Deviation 9.38 |
| Salmeterol 50 mcg BD | Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time | Minimum, DBP, Day 7 | -14.7 mmHg | Standard Deviation 9.33 |
Secondary
Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14
Blood samples were collected at pre-dose on Day 1, Day 7 and Day 14. Baseline was defined as the assessment done on pre-dose, Day 1. Change from Baseline was calculated by subtracting the Baseline (Day 1, pre-dose) value from the individual post Baseline (Day 7 and Day 14) values.
Time frame: Baseline (Day 1, pre-dose) up to Day 14
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14 | Fasting Glucose, Day 7 | -0.22 Millimole (mmol)/L) | Standard Deviation 0.742 |
| Placebo | Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14 | Fasting Glucose, Day 14 | 0.08 Millimole (mmol)/L) | Standard Deviation 1.229 |
| Placebo | Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14 | Fasting Potassium, Day 7 | 0.22 Millimole (mmol)/L) | Standard Deviation 0.328 |
| Placebo | Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14 | Fasting Potassium, Day 14 | 0.00 Millimole (mmol)/L) | Standard Deviation 0.285 |
| GW642444 100 mcg Once Daily | Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14 | Fasting Glucose, Day 14 | 0.57 Millimole (mmol)/L) | Standard Deviation 0.856 |
| GW642444 100 mcg Once Daily | Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14 | Fasting Potassium, Day 7 | -0.11 Millimole (mmol)/L) | Standard Deviation 0.436 |
| GW642444 100 mcg Once Daily | Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14 | Fasting Potassium, Day 14 | -0.16 Millimole (mmol)/L) | Standard Deviation 0.5 |
| GW642444 100 mcg Once Daily | Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14 | Fasting Glucose, Day 7 | 0.61 Millimole (mmol)/L) | Standard Deviation 1.175 |
| GW642444 400 mcg Once Daily | Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14 | Fasting Potassium, Day 7 | 0.03 Millimole (mmol)/L) | Standard Deviation 0.675 |
| GW642444 400 mcg Once Daily | Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14 | Fasting Glucose, Day 14 | 0.19 Millimole (mmol)/L) | Standard Deviation 0.639 |
| GW642444 400 mcg Once Daily | Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14 | Fasting Potassium, Day 14 | 0.02 Millimole (mmol)/L) | Standard Deviation 0.354 |
| GW642444 400 mcg Once Daily | Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14 | Fasting Glucose, Day 7 | 0.11 Millimole (mmol)/L) | Standard Deviation 0.673 |
| Salmeterol 50 mcg BD | Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14 | Fasting Potassium, Day 14 | 0.33 Millimole (mmol)/L) | Standard Deviation 0.504 |
| Salmeterol 50 mcg BD | Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14 | Fasting Glucose, Day 14 | 0.13 Millimole (mmol)/L) | Standard Deviation 1.04 |
| Salmeterol 50 mcg BD | Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14 | Fasting Glucose, Day 7 | 0.22 Millimole (mmol)/L) | Standard Deviation 1.103 |
| Salmeterol 50 mcg BD | Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14 | Fasting Potassium, Day 7 | 0.17 Millimole (mmol)/L) | Standard Deviation 0.737 |
Secondary
Change From Baseline in Pre-dose Weighted Mean Heart Rate (HR) Derived From 28.5 Hour (h) Ambulatory Blood Pressure Monitoring (ABPM) at Day 7 and 14
HR was measured using 28.5h ABPM on Day 1, Day 7 and Day 14. Baseline was defined as the pre-dose weighted mean of Day 1. Weighted mean was calculated by calculating the area under curve (AUC) of measurements made pre-dose on each day, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the average AUC minus Baseline (AAUCMB).
Time frame: Baseline (Day 1, pre-dose) up to Day 14
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Pre-dose Weighted Mean Heart Rate (HR) Derived From 28.5 Hour (h) Ambulatory Blood Pressure Monitoring (ABPM) at Day 7 and 14 | Day 7 | 4.60 Beats per minute (bpm) | Standard Deviation 5.689 |
| Placebo | Change From Baseline in Pre-dose Weighted Mean Heart Rate (HR) Derived From 28.5 Hour (h) Ambulatory Blood Pressure Monitoring (ABPM) at Day 7 and 14 | Day 14 | 1.13 Beats per minute (bpm) | Standard Deviation 7.151 |
| GW642444 100 mcg Once Daily | Change From Baseline in Pre-dose Weighted Mean Heart Rate (HR) Derived From 28.5 Hour (h) Ambulatory Blood Pressure Monitoring (ABPM) at Day 7 and 14 | Day 14 | -1.31 Beats per minute (bpm) | Standard Deviation 9.724 |
| GW642444 100 mcg Once Daily | Change From Baseline in Pre-dose Weighted Mean Heart Rate (HR) Derived From 28.5 Hour (h) Ambulatory Blood Pressure Monitoring (ABPM) at Day 7 and 14 | Day 7 | 0.18 Beats per minute (bpm) | Standard Deviation 7.253 |
| GW642444 400 mcg Once Daily | Change From Baseline in Pre-dose Weighted Mean Heart Rate (HR) Derived From 28.5 Hour (h) Ambulatory Blood Pressure Monitoring (ABPM) at Day 7 and 14 | Day 7 | 0.17 Beats per minute (bpm) | Standard Deviation 6.443 |
| GW642444 400 mcg Once Daily | Change From Baseline in Pre-dose Weighted Mean Heart Rate (HR) Derived From 28.5 Hour (h) Ambulatory Blood Pressure Monitoring (ABPM) at Day 7 and 14 | Day 14 | 4.29 Beats per minute (bpm) | Standard Deviation 9.646 |
| Salmeterol 50 mcg BD | Change From Baseline in Pre-dose Weighted Mean Heart Rate (HR) Derived From 28.5 Hour (h) Ambulatory Blood Pressure Monitoring (ABPM) at Day 7 and 14 | Day 7 | 0.95 Beats per minute (bpm) | Standard Deviation 8.793 |
| Salmeterol 50 mcg BD | Change From Baseline in Pre-dose Weighted Mean Heart Rate (HR) Derived From 28.5 Hour (h) Ambulatory Blood Pressure Monitoring (ABPM) at Day 7 and 14 | Day 14 | -0.22 Beats per minute (bpm) | Standard Deviation 7.345 |
Secondary
Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time
A 12-lead ECG was recorded on Day 1, 2, 7, 8, 14 and 15 with the participant in a supine position having rested in that position for at least 5 min before each reading. A total of 3 measurements separated by at least 1 min was taken at each visit and the mean recorded. The Baseline for pre-dose QTcF and QTcB measurements was the pre-dose assessment on Day 1. Weighted mean at 0-4 h for QTcF and QTcB was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the AAUCMB. The change from Baseline in maximum QTcF and QTcB at 0-4 h was calculated by subtracting the Baseline (pre-dose Day 1) value from the individual post-Baseline values.
Time frame: Baseline (Day 1, pre-dose) up to Day 15
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 14 | 7.713 Millisecond (msec) | Standard Deviation 14.081 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 15 | 5.690 Millisecond (msec) | Standard Deviation 15.6489 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Day 7, pre-dose | 2.548 Millisecond (msec) | Standard Deviation 14.3648 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Day 14, pre-dose | 2.445 Millisecond (msec) | Standard Deviation 14.8051 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 1 | 1.5102 Millisecond (msec) | Standard Deviation 9.80314 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 2 | 1.4515 Millisecond (msec) | Standard Deviation 9.95165 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 7 | 0.5278 Millisecond (msec) | Standard Deviation 11.61138 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 8 | -0.2753 Millisecond (msec) | Standard Deviation 13.37615 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 14 | 3.8254 Millisecond (msec) | Standard Deviation 14.80602 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 15 | 0.2258 Millisecond (msec) | Standard Deviation 15.48959 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 1 | 6.138 Millisecond (msec) | Standard Deviation 8.3179 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 2 | 7.238 Millisecond (msec) | Standard Deviation 9.8912 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 7 | 7.422 Millisecond (msec) | Standard Deviation 10.5173 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 8 | 4.765 Millisecond (msec) | Standard Deviation 14.1015 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Day 7, pre-dose | 3.490 Millisecond (msec) | Standard Deviation 14.817 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Day 14, pre-dose | 2.236 Millisecond (msec) | Standard Deviation 18.0863 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 1 | -1.4368 Millisecond (msec) | Standard Deviation 10.48286 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 2 | -0.8322 Millisecond (msec) | Standard Deviation 11.91468 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 7 | 0.6551 Millisecond (msec) | Standard Deviation 14.8489 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 8 | -2.1592 Millisecond (msec) | Standard Deviation 13.74186 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 14 | 1.5770 Millisecond (msec) | Standard Deviation 16.69052 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 15 | 0.2536 Millisecond (msec) | Standard Deviation 13.32367 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 1 | 4.600 Millisecond (msec) | Standard Deviation 9.015 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 2 | 5.130 Millisecond (msec) | Standard Deviation 12.9391 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 7 | 9.599 Millisecond (msec) | Standard Deviation 15.2443 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 8 | 4.930 Millisecond (msec) | Standard Deviation 15.4632 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 14 | 6.941 Millisecond (msec) | Standard Deviation 16.7794 |
| Placebo | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 15 | 6.646 Millisecond (msec) | Standard Deviation 14.1139 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 1 | 9.902 Millisecond (msec) | Standard Deviation 12.1193 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Day 7, pre-dose | 4.033 Millisecond (msec) | Standard Deviation 11.4412 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 14 | 0.8731 Millisecond (msec) | Standard Deviation 8.87134 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 14 | 1.1100 Millisecond (msec) | Standard Deviation 12.027 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 8 | -2.5879 Millisecond (msec) | Standard Deviation 12.83153 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Day 14, pre-dose | -2.150 Millisecond (msec) | Standard Deviation 12.5311 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 1 | 8.099 Millisecond (msec) | Standard Deviation 9.3911 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 7 | 3.1554 Millisecond (msec) | Standard Deviation 11.81255 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 15 | 3.569 Millisecond (msec) | Standard Deviation 10.9642 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 1 | 1.9240 Millisecond (msec) | Standard Deviation 9.38964 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 8 | -1.5941 Millisecond (msec) | Standard Deviation 9.79215 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 2 | 4.5011 Millisecond (msec) | Standard Deviation 12.15813 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 8 | 3.308 Millisecond (msec) | Standard Deviation 10.8675 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 1 | 1.2546 Millisecond (msec) | Standard Deviation 7.47433 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Day 14, pre-dose | -2.215 Millisecond (msec) | Standard Deviation 8.8487 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 2 | 8.860 Millisecond (msec) | Standard Deviation 7.1928 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 2 | 4.3733 Millisecond (msec) | Standard Deviation 7.91878 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Day 7, pre-dose | 4.166 Millisecond (msec) | Standard Deviation 10.8863 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 15 | 1.254 Millisecond (msec) | Standard Deviation 7.5156 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 7 | 8.586 Millisecond (msec) | Standard Deviation 11.5664 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 2 | 10.797 Millisecond (msec) | Standard Deviation 11.0215 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 15 | -2.1912 Millisecond (msec) | Standard Deviation 13.19232 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 7 | 9.884 Millisecond (msec) | Standard Deviation 10.8668 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 8 | 3.434 Millisecond (msec) | Standard Deviation 8.903 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 15 | -2.3710 Millisecond (msec) | Standard Deviation 9.06406 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 14 | 6.651 Millisecond (msec) | Standard Deviation 8.6838 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 7 | 3.4646 Millisecond (msec) | Standard Deviation 10.28713 |
| GW642444 100 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 14 | 7.250 Millisecond (msec) | Standard Deviation 12.2421 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 15 | 19.933 Millisecond (msec) | Standard Deviation 19.5949 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 14 | 9.0192 Millisecond (msec) | Standard Deviation 10.65315 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 15 | 9.3434 Millisecond (msec) | Standard Deviation 10.4065 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 2 | 19.846 Millisecond (msec) | Standard Deviation 26.4494 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 1 | 11.169 Millisecond (msec) | Standard Deviation 9.4879 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 2 | 16.650 Millisecond (msec) | Standard Deviation 18.1579 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 7 | 14.866 Millisecond (msec) | Standard Deviation 11.4977 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 8 | 15.425 Millisecond (msec) | Standard Deviation 14.2054 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 15 | 15.698 Millisecond (msec) | Standard Deviation 11.7395 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 7 | 19.748 Millisecond (msec) | Standard Deviation 18.6338 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Day 7, pre-dose | 3.491 Millisecond (msec) | Standard Deviation 17.2891 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Day 14, pre-dose | 0.364 Millisecond (msec) | Standard Deviation 13.4871 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 1 | 7.2528 Millisecond (msec) | Standard Deviation 14.9135 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 2 | 12.1052 Millisecond (msec) | Standard Deviation 24.42441 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 8 | 22.344 Millisecond (msec) | Standard Deviation 21.0882 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 7 | 10.6108 Millisecond (msec) | Standard Deviation 16.58029 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 8 | 12.5741 Millisecond (msec) | Standard Deviation 22.22059 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 8 | 8.7690 Millisecond (msec) | Standard Deviation 14.91393 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 14 | 11.8220 Millisecond (msec) | Standard Deviation 16.58898 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 14 | 16.715 Millisecond (msec) | Standard Deviation 9.848 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 15 | 11.8730 Millisecond (msec) | Standard Deviation 19.0666 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Day 7, pre-dose | 4.557 Millisecond (msec) | Standard Deviation 12.5535 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Day 14, pre-dose | 1.450 Millisecond (msec) | Standard Deviation 11.8828 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 14 | 20.698 Millisecond (msec) | Standard Deviation 14.3145 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 1 | 5.1325 Millisecond (msec) | Standard Deviation 9.99564 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 2 | 10.5957 Millisecond (msec) | Standard Deviation 16.92211 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 1 | 15.314 Millisecond (msec) | Standard Deviation 12.8527 |
| GW642444 400 mcg Once Daily | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 7 | 8.8287 Millisecond (msec) | Standard Deviation 10.77947 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 15 | 0.585 Millisecond (msec) | Standard Deviation 13.3811 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 8 | -0.707 Millisecond (msec) | Standard Deviation 16.9799 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 14 | -3.7270 Millisecond (msec) | Standard Deviation 14.27827 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 14 | -0.394 Millisecond (msec) | Standard Deviation 13.4669 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 7 | 2.146 Millisecond (msec) | Standard Deviation 13.5782 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 15 | 3.343 Millisecond (msec) | Standard Deviation 14.0019 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 7 | -2.6011 Millisecond (msec) | Standard Deviation 14.22194 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 2 | 3.940 Millisecond (msec) | Standard Deviation 8.425 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 2 | -1.0685 Millisecond (msec) | Standard Deviation 8.45786 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Day 7, pre-dose | -1.622 Millisecond (msec) | Standard Deviation 14.8225 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 15 | -5.4291 Millisecond (msec) | Standard Deviation 11.64105 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 2 | 6.038 Millisecond (msec) | Standard Deviation 10.024 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 1 | 8.448 Millisecond (msec) | Standard Deviation 9.0077 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 1 | 0.4135 Millisecond (msec) | Standard Deviation 7.78546 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Day 14, pre-dose | -5.803 Millisecond (msec) | Standard Deviation 12.696 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 2 | 0.4464 Millisecond (msec) | Standard Deviation 10.8999 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 14 | 1.685 Millisecond (msec) | Standard Deviation 15.244 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Day 14, pre-dose | -6.254 Millisecond (msec) | Standard Deviation 14.4987 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Maximum 0-4 h, Day 1 | 6.334 Millisecond (msec) | Standard Deviation 7.0411 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 7 | -1.1323 Millisecond (msec) | Standard Deviation 16.11649 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 8 | 2.949 Millisecond (msec) | Standard Deviation 17.3141 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Maximum 0-4 h, Day 7 | 5.125 Millisecond (msec) | Standard Deviation 15.1542 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 8 | -5.8609 Millisecond (msec) | Standard Deviation 15.48314 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 8 | -3.9026 Millisecond (msec) | Standard Deviation 16.69124 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 1 | -0.2457 Millisecond (msec) | Standard Deviation 6.77374 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Day 7, pre-dose | -0.982 Millisecond (msec) | Standard Deviation 18.2505 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcF, Weighted mean 0-4 h, Day 15 | -7.9229 Millisecond (msec) | Standard Deviation 9.51166 |
| Salmeterol 50 mcg BD | Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time | QTcB, Weighted mean 0-4 h, Day 14 | -1.9538 Millisecond (msec) | Standard Deviation 15.99966 |
Secondary
Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14
FEV1 is defined as the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Lung function test of FEV1 was performed at the approximately same time at each visit in the morning and highest of the 3 measurements were recorded. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean FEV1 over 22-24 h was obtained at Day 1, Day 7 and Day 14 which was recorded up to Day 2, Day 8 and Day 15. Baseline was defined as the assessment on Day 1 pre-dose. Change from Baseline was calculated by subtracting the Baseline (Day 1, pre-dose) value from the individual post Baseline (Day 1, Day 7 and Day 14) values.
Time frame: Baseline (Day 1, pre-dose) up to Day 15
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14 | Day 1 | 0.0191 L | Standard Error 0.04224 |
| Placebo | Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14 | Day 14 | -0.0225 L | Standard Error 0.05719 |
| Placebo | Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14 | Day 7 | -0.0174 L | Standard Error 0.0564 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14 | Day 1 | 0.1322 L | Standard Error 0.04171 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14 | Day 14 | 0.1166 L | Standard Error 0.06178 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14 | Day 7 | 0.1568 L | Standard Error 0.05818 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14 | Day 7 | 0.1539 L | Standard Error 0.06073 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14 | Day 1 | 0.1781 L | Standard Error 0.04194 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14 | Day 14 | 0.1681 L | Standard Error 0.06615 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14 | Day 1 | 0.0955 L | Standard Error 0.04043 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14 | Day 14 | 0.0732 L | Standard Error 0.05827 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14 | Day 7 | 0.1204 L | Standard Error 0.05723 |
Comparison: Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 1.95% CI: [-0.0031, 0.2293]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 1.95% CI: [0.0408, 0.2771]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 1.95% CI: [-0.0375, 0.1903]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 7.95% CI: [0.0178, 0.3305]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 7.95% CI: [0.006, 0.3365]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 7.95% CI: [-0.0233, 0.2987]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 14.95% CI: [-0.0266, 0.3046]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 14.95% CI: [0.0177, 0.3635]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 14.95% CI: [-0.0686, 0.2599]Regression, Linear
Secondary
Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time
Blood samples were collected at pre-dose and 4 h post-dose on Day 1, Day 2, Day 7, Day 8, Day 14 and Day 15. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. Baseline was defined as the assessment on Day 1 pre-dose. The weighted mean change from Baseline was the AAUCMB. Change from Baseline in maximum glucose 0-4 h and minimum potassium 0-4 h was calculated by subtracting the Baseline (Day 1, pre-dose) value from the individual post Baseline (Day 1 to Day 15) values.
Time frame: Baseline (Day 1, pre-dose) up to Day 15
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 2 | 0.21 mmol/L | Standard Error 0.363 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 1 | 0.183 mmol/L | Standard Error 0.0999 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 2 | 0.07 mmol/L | Standard Error 0.127 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 8 | -0.183 mmol/L | Standard Error 0.3111 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 15 | 0.155 mmol/L | Standard Error 0.112 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 2 | 0.376 mmol/L | Standard Error 0.1575 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 2 | -0.137 mmol/L | Standard Error 0.2749 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 14 | 0.218 mmol/L | Standard Error 0.114 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 7 | -0.002 mmol/L | Standard Error 0.1978 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 7 | 0.267 mmol/L | Standard Error 0.1318 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 15 | -0.100 mmol/L | Standard Error 0.2505 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 8 | 0.247 mmol/L | Standard Error 0.1051 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 8 | 0.09 mmol/L | Standard Error 0.099 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 15 | 0.21 mmol/L | Standard Error 0.348 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 8 | 0.28 mmol/L | Standard Error 0.431 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 14 | 0.37 mmol/L | Standard Error 0.434 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 14 | -0.06 mmol/L | Standard Error 0.091 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 14 | 0.193 mmol/L | Standard Error 0.2104 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 7 | 0.52 mmol/L | Standard Error 0.367 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 1 | 0.65 mmol/L | Standard Error 0.361 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 15 | -0.02 mmol/L | Standard Error 0.099 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 7 | 0.07 mmol/L | Standard Error 0.143 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 1 | -0.12 mmol/L | Standard Error 0.094 |
| Placebo | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 1 | 0.048 mmol/L | Standard Error 0.2097 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 2 | 0.61 mmol/L | Standard Error 0.357 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 1 | -0.31 mmol/L | Standard Error 0.104 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 2 | -0.03 mmol/L | Standard Error 0.135 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 2 | 0.062 mmol/L | Standard Error 0.2689 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 7 | -0.47 mmol/L | Standard Error 0.158 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 8 | 0.13 mmol/L | Standard Error 0.109 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 15 | -0.006 mmol/L | Standard Error 0.2404 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 14 | -0.21 mmol/L | Standard Error 0.1 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 15 | 0.03 mmol/L | Standard Error 0.109 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 1 | -0.110 mmol/L | Standard Error 0.1062 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 2 | 0.160 mmol/L | Standard Error 0.1634 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 7 | -0.219 mmol/L | Standard Error 0.1421 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 7 | 0.095 mmol/L | Standard Error 0.1994 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 8 | 0.322 mmol/L | Standard Error 0.1115 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 14 | -0.081 mmol/L | Standard Error 0.1233 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 1 | 0.057 mmol/L | Standard Error 0.2061 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 15 | 0.328 mmol/L | Standard Error 0.1197 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 1 | 0.51 mmol/L | Standard Error 0.365 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 8 | 0.061 mmol/L | Standard Error 0.32 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 7 | 0.47 mmol/L | Standard Error 0.368 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 8 | 0.53 mmol/L | Standard Error 0.425 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 14 | 0.42 mmol/L | Standard Error 0.431 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 15 | 0.43 mmol/L | Standard Error 0.345 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 14 | 0.250 mmol/L | Standard Error 0.2046 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 1 | -0.188 mmol/L | Standard Error 0.1016 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 15 | 1.05 mmol/L | Standard Error 0.392 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 1 | 0.94 mmol/L | Standard Error 0.357 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 14 | 1.12 mmol/L | Standard Error 0.473 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 2 | 0.497 mmol/L | Standard Error 0.2711 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 15 | -0.37 mmol/L | Standard Error 0.117 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 2 | 0.89 mmol/L | Standard Error 0.35 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 15 | 0.258 mmol/L | Standard Error 0.2737 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 14 | -0.29 mmol/L | Standard Error 0.103 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 14 | 0.055 mmol/L | Standard Error 0.2309 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 7 | 1.05 mmol/L | Standard Error 0.402 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 8 | 0.613 mmol/L | Standard Error 0.3614 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 8 | -0.30 mmol/L | Standard Error 0.111 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 7 | -0.295 mmol/L | Standard Error 0.1664 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 1 | -0.35 mmol/L | Standard Error 0.095 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 8 | -0.027 mmol/L | Standard Error 0.1311 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 7 | 0.406 mmol/L | Standard Error 0.2349 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 2 | -0.160 mmol/L | Standard Error 0.1609 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 8 | 1.13 mmol/L | Standard Error 0.464 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 14 | -0.053 mmol/L | Standard Error 0.1325 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 7 | -0.47 mmol/L | Standard Error 0.161 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 1 | 0.285 mmol/L | Standard Error 0.2068 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 2 | -0.31 mmol/L | Standard Error 0.125 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 15 | -0.041 mmol/L | Standard Error 0.1276 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 15 | 0.02 mmol/L | Standard Error 0.113 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 1 | 0.140 mmol/L | Standard Error 0.1946 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 2 | -0.072 mmol/L | Standard Error 0.255 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 7 | 0.078 mmol/L | Standard Error 0.1929 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 8 | -0.039 mmol/L | Standard Error 0.3097 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 14 | 0.006 mmol/L | Standard Error 0.1956 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 15 | 0.078 mmol/L | Standard Error 0.2413 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 1 | 0.030 mmol/L | Standard Error 0.1063 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 2 | 0.358 mmol/L | Standard Error 0.1576 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 7 | 0.077 mmol/L | Standard Error 0.1415 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 8 | 0.350 mmol/L | Standard Error 0.1154 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 14 | 0.123 mmol/L | Standard Error 0.1224 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 15 | 0.293 mmol/L | Standard Error 0.1234 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 1 | 0.48 mmol/L | Standard Error 0.336 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 2 | 0.44 mmol/L | Standard Error 0.337 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 7 | 0.65 mmol/L | Standard Error 0.359 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 8 | 0.60 mmol/L | Standard Error 0.429 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 14 | 0.37 mmol/L | Standard Error 0.433 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 15 | 0.70 mmol/L | Standard Error 0.346 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 1 | -0.32 mmol/L | Standard Error 0.096 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 2 | 0.05 mmol/L | Standard Error 0.13 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 7 | -0.27 mmol/L | Standard Error 0.156 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 8 | 0.13 mmol/L | Standard Error 0.113 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 14 | -0.12 mmol/L | Standard Error 0.103 |
Comparison: Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 1.95% CI: [-0.59, 0.608]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 1.95% CI: [-0.354, 0.829]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 1.95% CI: [-0.469, 0.654]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 2.95% CI: [-0.591, 0.988]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 2.95% CI: [-0.152, 1.418]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 2.95% CI: [-0.667, 0.797]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 7.95% CI: [-0.476, 0.67]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 7.95% CI: [-0.208, 1.024]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 7.95% CI: [-0.471, 0.631]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 8.95% CI: [-0.66, 1.149]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 8.95% CI: [-0.174, 1.766]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 8.95% CI: [-0.742, 1.03]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 14.95% CI: [-0.556, 0.669]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 14.95% CI: [-0.767, 0.491]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 14.95% CI: [-0.765, 0.391]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 15.95% CI: [-0.619, 0.806]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 15.95% CI: [-0.39, 1.105]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 15.95% CI: [-0.522, 0.877]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 1.95% CI: [-0.586, -0.001]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 1.95% CI: [-0.657, -0.085]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 1.95% CI: [-0.44, 0.133]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 2.95% CI: [-0.679, 0.247]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 2.95% CI: [-0.998, -0.074]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 2.95% CI: [-0.452, 0.416]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 7.95% CI: [-0.878, -0.095]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 7.95% CI: [-0.99, -0.135]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 7.95% CI: [-0.575, 0.196]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 8.95% CI: [-0.235, 0.385]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 8.95% CI: [-0.623, 0.073]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 8.95% CI: [-0.213, 0.418]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 14.95% CI: [-0.64, 0.042]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 14.95% CI: [-0.621, 0.079]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 14.95% CI: [-0.432, 0.243]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 15.95% CI: [-0.158, 0.505]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 15.95% CI: [-0.535, 0.143]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 15.95% CI: [-0.198, 0.475]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 1.95% CI: [-1.18, 0.9]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 1.95% CI: [-0.72, 1.3]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 1.95% CI: [-1.15, 0.8]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 2.95% CI: [-0.64, 1.44]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 2.95% CI: [-0.32, 1.7]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 2.95% CI: [-0.74, 1.2]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 7.95% CI: [-1.11, 1.01]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 7.95% CI: [-0.57, 1.62]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 7.95% CI: [-0.89, 1.15]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 8.95% CI: [-0.98, 1.5]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 8.95% CI: [-0.42, 2.14]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 8.95% CI: [-0.9, 1.54]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 14.95% CI: [-1.2, 1.3]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 14.95% CI: [-0.53, 2.03]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 14.95% CI: [-1.23, 1.23]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 15.95% CI: [-0.78, 1.23]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 15.95% CI: [-0.21, 1.89]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 15.95% CI: [-0.5, 1.48]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 1.95% CI: [-0.47, 0.09]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 1.95% CI: [-0.49, 0.04]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 1.95% CI: [-0.46, 0.07]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 2.95% CI: [-0.47, 0.27]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 2.95% CI: [-0.73, -0.03]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 2.95% CI: [-0.37, 0.34]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 7.95% CI: [-0.97, -0.12]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 7.95% CI: [-0.98, -0.12]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 7.95% CI: [-0.76, 0.08]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 8.95% CI: [-0.26, 0.33]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 8.95% CI: [-0.7, -0.1]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 8.95% CI: [-0.26, 0.34]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 14.95% CI: [-0.42, 0.12]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 14.95% CI: [-0.51, 0.04]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 14.95% CI: [-0.34, 0.21]Regression, Linear
Comparison: Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 15.95% CI: [-0.25, 0.35]Regression, Linear
Comparison: Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 15.95% CI: [-0.66, -0.05]Regression, Linear
Comparison: Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 15.95% CI: [-0.26, 0.34]Regression, Linear
Secondary
Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time
BP was measured using 28.5 h ABPM. Weighted mean SBP and DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. Weighted mean SBP and DBP at 0-24 h post-dose was obtained on Day 1, 7 and 14. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. Baseline was defined as the weighted mean SBP and DBP on pre-dose Day 1. The weighted mean change from Baseline was the AAUCMB. Data is reported for change from Baseline in weighted mean pre-dose values at Day 7 and Day 14; change from Baseline in weighted mean over 0-4 h at Day 1, 2, 7, 8, 14 and 15; and change from Baseline in weighted mean over 0-24 h at Day 1, 7 and 14.
Time frame: Baseline (Day 1, pre-dose) up to Day 15
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 8, 0-4 h | -1.13 Millimeter of mercury (mmHg) | Standard Deviation 7.097 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 14, pre-dose | -0.71 Millimeter of mercury (mmHg) | Standard Deviation 7.733 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 2, 0-4 h | -8.96 Millimeter of mercury (mmHg) | Standard Deviation 12.423 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 7, 0-4 h | 0.90 Millimeter of mercury (mmHg) | Standard Deviation 6.246 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 1, 0-4 h | 2.72 Millimeter of mercury (mmHg) | Standard Deviation 5.654 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 7, pre-dose | -7.21 Millimeter of mercury (mmHg) | Standard Deviation 10.073 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 2, 0-4 h | -0.11 Millimeter of mercury (mmHg) | Standard Deviation 5.75 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 14, pre-dose | -6.17 Millimeter of mercury (mmHg) | Standard Deviation 9.602 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 7, 0-24 h | -5.46 Millimeter of mercury (mmHg) | Standard Deviation 7.29 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 7, 0-4 h | -8.98 Millimeter of mercury (mmHg) | Standard Deviation 9.838 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 8, 0-4 h | -11.11 Millimeter of mercury (mmHg) | Standard Deviation 11.261 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 15, 0-4 h | -1.26 Millimeter of mercury (mmHg) | Standard Deviation 4.685 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 14, 0-4 h | -8.82 Millimeter of mercury (mmHg) | Standard Deviation 12.338 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 14, 0-24 h | -7.75 Millimeter of mercury (mmHg) | Standard Deviation 7.996 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 15, 0-4 h | -7.96 Millimeter of mercury (mmHg) | Standard Deviation 9.639 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 1, 0-4 h | -3.99 Millimeter of mercury (mmHg) | Standard Deviation 7.343 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 14, 0-4 h | -2.62 Millimeter of mercury (mmHg) | Standard Deviation 7.857 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 7, 0-24 h | -13.76 Millimeter of mercury (mmHg) | Standard Deviation 10.592 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 14, 0-24 h | -14.29 Millimeter of mercury (mmHg) | Standard Deviation 12.265 |
| Placebo | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 7, pre-dose | -0.60 Millimeter of mercury (mmHg) | Standard Deviation 8.011 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 8, 0-4 h | -3.64 Millimeter of mercury (mmHg) | Standard Deviation 5.083 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 7, pre-dose | 0.21 Millimeter of mercury (mmHg) | Standard Deviation 9.021 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 7, 0-24 h | -7.28 Millimeter of mercury (mmHg) | Standard Deviation 5.863 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 7, 0-4 h | -1.39 Millimeter of mercury (mmHg) | Standard Deviation 5.36 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 8, 0-4 h | -10.67 Millimeter of mercury (mmHg) | Standard Deviation 10.713 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 14, pre-dose | -0.88 Millimeter of mercury (mmHg) | Standard Deviation 8.53 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 7, pre-dose | -4.54 Millimeter of mercury (mmHg) | Standard Deviation 16.602 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 14, 0-24 h | -7.95 Millimeter of mercury (mmHg) | Standard Deviation 6.409 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 14, 0-24 h | -14.13 Millimeter of mercury (mmHg) | Standard Deviation 11.422 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 1, 0-4 h | -1.49 Millimeter of mercury (mmHg) | Standard Deviation 5.611 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 14, 0-4 h | -8.14 Millimeter of mercury (mmHg) | Standard Deviation 9.324 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 2, 0-4 h | -5.02 Millimeter of mercury (mmHg) | Standard Deviation 6.872 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 7, 0-24 h | -15.34 Millimeter of mercury (mmHg) | Standard Deviation 11.591 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 2, 0-4 h | -11.76 Millimeter of mercury (mmHg) | Standard Deviation 11.715 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 14, 0-4 h | -2.89 Millimeter of mercury (mmHg) | Standard Deviation 5.849 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 1, 0-4 h | -6.18 Millimeter of mercury (mmHg) | Standard Deviation 7.152 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 15, 0-4 h | -11.86 Millimeter of mercury (mmHg) | Standard Deviation 13.264 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 7, 0-4 h | -7.86 Millimeter of mercury (mmHg) | Standard Deviation 10.724 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 14, pre-dose | -4.15 Millimeter of mercury (mmHg) | Standard Deviation 17.991 |
| GW642444 100 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 15, 0-4 h | -2.78 Millimeter of mercury (mmHg) | Standard Deviation 4.98 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 1, 0-4 h | 0.95 Millimeter of mercury (mmHg) | Standard Deviation 7.894 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 7, pre-dose | -1.67 Millimeter of mercury (mmHg) | Standard Deviation 9.823 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 14, pre-dose | -1.39 Millimeter of mercury (mmHg) | Standard Deviation 10.228 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 1, 0-4 h | -3.23 Millimeter of mercury (mmHg) | Standard Deviation 10.613 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 2, 0-4 h | -5.73 Millimeter of mercury (mmHg) | Standard Deviation 7.883 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 7, 0-4 h | -2.43 Millimeter of mercury (mmHg) | Standard Deviation 8.855 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 8, 0-4 h | -6.14 Millimeter of mercury (mmHg) | Standard Deviation 14.561 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 14, 0-4 h | -9.36 Millimeter of mercury (mmHg) | Standard Deviation 10.142 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 15, 0-4 h | -11.27 Millimeter of mercury (mmHg) | Standard Deviation 11.249 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 7, 0-24 h | -7.75 Millimeter of mercury (mmHg) | Standard Deviation 7.552 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 14, 0-24 h | -12.79 Millimeter of mercury (mmHg) | Standard Deviation 10.319 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 7, pre-dose | -0.33 Millimeter of mercury (mmHg) | Standard Deviation 5.888 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 14, pre-dose | -0.17 Millimeter of mercury (mmHg) | Standard Deviation 8.108 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 2, 0-4 h | -2.24 Millimeter of mercury (mmHg) | Standard Deviation 4.98 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 7, 0-4 h | -1.39 Millimeter of mercury (mmHg) | Standard Deviation 4.325 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 8, 0-4 h | -0.97 Millimeter of mercury (mmHg) | Standard Deviation 6.468 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 14, 0-4 h | -3.20 Millimeter of mercury (mmHg) | Standard Deviation 7.134 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 15, 0-4 h | -4.76 Millimeter of mercury (mmHg) | Standard Deviation 5.665 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 7, 0-24 h | -4.50 Millimeter of mercury (mmHg) | Standard Deviation 4.737 |
| GW642444 400 mcg Once Daily | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 14, 0-24 h | -5.91 Millimeter of mercury (mmHg) | Standard Deviation 6.979 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 14, 0-24 h | -14.34 Millimeter of mercury (mmHg) | Standard Deviation 10.636 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 7, 0-24 h | -14.82 Millimeter of mercury (mmHg) | Standard Deviation 10.81 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 7, 0-24 h | -13.97 Millimeter of mercury (mmHg) | Standard Deviation 7.61 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 8, 0-4 h | -10.18 Millimeter of mercury (mmHg) | Standard Deviation 10.093 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 15, 0-4 h | -14.97 Millimeter of mercury (mmHg) | Standard Deviation 11.794 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 14, 0-4 h | -11.06 Millimeter of mercury (mmHg) | Standard Deviation 13.844 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 14, pre-dose | -12.06 Millimeter of mercury (mmHg) | Standard Deviation 14.143 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 14, 0-4 h | -7.43 Millimeter of mercury (mmHg) | Standard Deviation 10.323 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 8, 0-4 h | -13.42 Millimeter of mercury (mmHg) | Standard Deviation 13.907 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 7, 0-4 h | -8.34 Millimeter of mercury (mmHg) | Standard Deviation 11.266 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 7, pre-dose | -6.55 Millimeter of mercury (mmHg) | Standard Deviation 8.572 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 15, 0-4 h | -9.34 Millimeter of mercury (mmHg) | Standard Deviation 10.566 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 2, 0-4 h | -7.12 Millimeter of mercury (mmHg) | Standard Deviation 8.388 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 1, 0-4 h | -5.04 Millimeter of mercury (mmHg) | Standard Deviation 4.22 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | SBP, Day 1, 0-4 h | -4.27 Millimeter of mercury (mmHg) | Standard Deviation 8.566 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 2, 0-4 h | -5.29 Millimeter of mercury (mmHg) | Standard Deviation 3.166 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 14, pre-dose | -6.89 Millimeter of mercury (mmHg) | Standard Deviation 9.168 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 7, pre-dose | -5.59 Millimeter of mercury (mmHg) | Standard Deviation 7.151 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 14, 0-24 h | -12.53 Millimeter of mercury (mmHg) | Standard Deviation 8.622 |
| Salmeterol 50 mcg BD | Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time | DBP, Day 7, 0-4 h | -7.13 Millimeter of mercury (mmHg) | Standard Deviation 8.469 |
Secondary
Cmax of CCI2189 at Day 1, 7 and 14
CCI2189 is a counterion of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data.
Time frame: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Population: PK Concentration Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Cmax of CCI2189 at Day 1, 7 and 14 | Day 1 | 4.692 ng/mL | Geometric Coefficient of Variation 34.06 |
| Placebo | Cmax of CCI2189 at Day 1, 7 and 14 | Day 7 | 4.578 ng/mL | Geometric Coefficient of Variation 27.23 |
| Placebo | Cmax of CCI2189 at Day 1, 7 and 14 | Day 14 | 5.115 ng/mL | Geometric Coefficient of Variation 34.66 |
| GW642444 100 mcg Once Daily | Cmax of CCI2189 at Day 1, 7 and 14 | Day 1 | 15.650 ng/mL | Geometric Coefficient of Variation 55.22 |
| GW642444 100 mcg Once Daily | Cmax of CCI2189 at Day 1, 7 and 14 | Day 7 | 21.293 ng/mL | Geometric Coefficient of Variation 37.74 |
| GW642444 100 mcg Once Daily | Cmax of CCI2189 at Day 1, 7 and 14 | Day 14 | 18.315 ng/mL | Geometric Coefficient of Variation 28.69 |
Secondary
Cmax of GW630200 and GSK932009 at Day 1, 7 and 14
GW630200 and GSK932009 are metabolites of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data.
Time frame: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Population: PK Concentration Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Cmax of GW630200 and GSK932009 at Day 1, 7 and 14 | GW630200, Day 14 | NA pg/mL | — |
| Placebo | Cmax of GW630200 and GSK932009 at Day 1, 7 and 14 | GSK932009, Day 7 | 235.459 pg/mL | Geometric Coefficient of Variation 17.81 |
| Placebo | Cmax of GW630200 and GSK932009 at Day 1, 7 and 14 | GW630200, Day 7 | NA pg/mL | — |
| Placebo | Cmax of GW630200 and GSK932009 at Day 1, 7 and 14 | GSK932009, Day 14 | 228.419 pg/mL | Geometric Coefficient of Variation 19.25 |
| Placebo | Cmax of GW630200 and GSK932009 at Day 1, 7 and 14 | GW630200, Day 1 | NA pg/mL | — |
| GW642444 100 mcg Once Daily | Cmax of GW630200 and GSK932009 at Day 1, 7 and 14 | GSK932009, Day 7 | 460.352 pg/mL | Geometric Coefficient of Variation 69.16 |
| GW642444 100 mcg Once Daily | Cmax of GW630200 and GSK932009 at Day 1, 7 and 14 | GSK932009, Day 14 | 391.680 pg/mL | Geometric Coefficient of Variation 37.49 |
| GW642444 100 mcg Once Daily | Cmax of GW630200 and GSK932009 at Day 1, 7 and 14 | GW630200, Day 1 | NA pg/mL | — |
| GW642444 100 mcg Once Daily | Cmax of GW630200 and GSK932009 at Day 1, 7 and 14 | GW630200, Day 7 | NA pg/mL | — |
| GW642444 100 mcg Once Daily | Cmax of GW630200 and GSK932009 at Day 1, 7 and 14 | GW630200, Day 14 | NA pg/mL | — |
| GW642444 100 mcg Once Daily | Cmax of GW630200 and GSK932009 at Day 1, 7 and 14 | GSK932009, Day 1 | 311.740 pg/mL | Geometric Coefficient of Variation 36.96 |
Secondary
Cmax of Salmeterol at Day 1, 7 and 14
Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data.
Time frame: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Population: PK Concentration Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Cmax of Salmeterol at Day 1, 7 and 14 | Day 1 | 50.218 pg*h/mL | Geometric Coefficient of Variation 45.71 |
| Placebo | Cmax of Salmeterol at Day 1, 7 and 14 | Day 7 | 59.943 pg*h/mL | Geometric Coefficient of Variation 49.73 |
| Placebo | Cmax of Salmeterol at Day 1, 7 and 14 | Day 14 | 51.983 pg*h/mL | Geometric Coefficient of Variation 29.13 |
Secondary
Maximum Concentration (Cmax) of GW642444H at Day 1, 7 and 14
Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data.
Time frame: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Population: PK Concentration Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Maximum Concentration (Cmax) of GW642444H at Day 1, 7 and 14 | Day 1 | 78.851 pg/mL | Geometric Coefficient of Variation 45.85 |
| Placebo | Maximum Concentration (Cmax) of GW642444H at Day 1, 7 and 14 | Day 7 | 82.642 pg/mL | Geometric Coefficient of Variation 64.09 |
| Placebo | Maximum Concentration (Cmax) of GW642444H at Day 1, 7 and 14 | Day 14 | 92.089 pg/mL | Geometric Coefficient of Variation 50.15 |
| GW642444 100 mcg Once Daily | Maximum Concentration (Cmax) of GW642444H at Day 1, 7 and 14 | Day 1 | 226.407 pg/mL | Geometric Coefficient of Variation 108.53 |
| GW642444 100 mcg Once Daily | Maximum Concentration (Cmax) of GW642444H at Day 1, 7 and 14 | Day 7 | 427.282 pg/mL | Geometric Coefficient of Variation 49.41 |
| GW642444 100 mcg Once Daily | Maximum Concentration (Cmax) of GW642444H at Day 1, 7 and 14 | Day 14 | 308.546 pg/mL | Geometric Coefficient of Variation 24.25 |
Secondary
Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time
FEV1 is defined as the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was assessed pre-dose and post-dose at Day 1, 2, 7, 8, 14 and 15. Lung function test of FEV1 was performed at the approximately same time at each visit in the morning and highest of the 3 measurements were recorded. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean FEV1 0-4 h and maximum FEV1 0-4 h was obtained at Day 1, 2, 7, 8, 14 and 15.
Time frame: Day 1 up to Day 15
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 8 | 1.717 L | Standard Deviation 0.551 |
| Placebo | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 15 | 1.704 L | Standard Deviation 0.502 |
| Placebo | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 2 | 1.741 L | Standard Deviation 0.4597 |
| Placebo | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 1 | 1.6180 L | Standard Deviation 0.49986 |
| Placebo | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 7 | 1.712 L | Standard Deviation 0.4639 |
| Placebo | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 7 | 1.6261 L | Standard Deviation 0.43336 |
| Placebo | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 8 | 1.6375 L | Standard Deviation 0.53044 |
| Placebo | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 2 | 1.6498 L | Standard Deviation 0.44952 |
| Placebo | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 14 | 1.684 L | Standard Deviation 0.5236 |
| Placebo | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 14 | 1.6861 L | Standard Deviation 0.50464 |
| Placebo | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 15 | 1.6155 L | Standard Deviation 0.49847 |
| Placebo | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 1 | 1.698 L | Standard Deviation 0.4811 |
| GW642444 100 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 2 | 1.5796 L | Standard Deviation 0.52525 |
| GW642444 100 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 1 | 1.578 L | Standard Deviation 0.5034 |
| GW642444 100 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 8 | 1.6027 L | Standard Deviation 0.5166 |
| GW642444 100 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 7 | 1.593 L | Standard Deviation 0.5196 |
| GW642444 100 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 8 | 1.620 L | Standard Deviation 0.5182 |
| GW642444 100 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 2 | 1.622 L | Standard Deviation 0.5329 |
| GW642444 100 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 1 | 1.5294 L | Standard Deviation 0.49878 |
| GW642444 100 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 15 | 1.4719 L | Standard Deviation 0.47004 |
| GW642444 100 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 14 | 1.5326 L | Standard Deviation 0.51142 |
| GW642444 100 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 7 | 1.5427 L | Standard Deviation 0.51959 |
| GW642444 100 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 15 | 1.587 L | Standard Deviation 0.506 |
| GW642444 100 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 14 | 1.569 L | Standard Deviation 0.5193 |
| GW642444 400 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 2 | 2.168 L | Standard Deviation 0.6217 |
| GW642444 400 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 1 | 2.0224 L | Standard Deviation 0.62567 |
| GW642444 400 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 2 | 2.1015 L | Standard Deviation 0.62389 |
| GW642444 400 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 7 | 2.0355 L | Standard Deviation 0.61827 |
| GW642444 400 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 8 | 2.0637 L | Standard Deviation 0.61246 |
| GW642444 400 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 14 | 2.1411 L | Standard Deviation 0.61845 |
| GW642444 400 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 15 | 2.0638 L | Standard Deviation 0.53939 |
| GW642444 400 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 1 | 2.089 L | Standard Deviation 0.6341 |
| GW642444 400 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 7 | 2.104 L | Standard Deviation 0.6429 |
| GW642444 400 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 8 | 2.120 L | Standard Deviation 0.617 |
| GW642444 400 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 14 | 2.203 L | Standard Deviation 0.6287 |
| GW642444 400 mcg Once Daily | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 15 | 2.156 L | Standard Deviation 0.5717 |
| Salmeterol 50 mcg BD | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 15 | 1.6611 L | Standard Deviation 0.5136 |
| Salmeterol 50 mcg BD | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 14 | 1.6457 L | Standard Deviation 0.61933 |
| Salmeterol 50 mcg BD | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 1 | 1.6674 L | Standard Deviation 0.47398 |
| Salmeterol 50 mcg BD | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 8 | 1.729 L | Standard Deviation 0.5083 |
| Salmeterol 50 mcg BD | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 8 | 1.6599 L | Standard Deviation 0.51218 |
| Salmeterol 50 mcg BD | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 7 | 1.7053 L | Standard Deviation 0.52221 |
| Salmeterol 50 mcg BD | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 15 | 1.745 L | Standard Deviation 0.5673 |
| Salmeterol 50 mcg BD | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 14 | 1.664 L | Standard Deviation 0.5901 |
| Salmeterol 50 mcg BD | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 2 | 1.726 L | Standard Deviation 0.5514 |
| Salmeterol 50 mcg BD | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 1 | 1.708 L | Standard Deviation 0.4848 |
| Salmeterol 50 mcg BD | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Weighted mean 0-4, Day 2 | 1.6480 L | Standard Deviation 0.53142 |
| Salmeterol 50 mcg BD | Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time | Maximum 0-4 h, Day 7 | 1.766 L | Standard Deviation 0.5245 |
Secondary
Mean Hourly HR 0-24 h at Day 1, 7 and 14
HR was measured using 28.5 h ABPM. The assessments were analyzed hourly as 0-1 h, 1-2 h, 2-3 h, 3-4 h, 4-5 h, 5-6 h, 6-7 h, 7-8 h, 8-9 h, 9-10 h, 10-11 h, 11-12 h, 12-13 h, 13-14 h, 14-15 h, 15-16 h, 16-17 h, 17-18 h, 18-19 h, 19-20 h, 20-21 h, 21-22 h, 22-23 h and 23-24 h at Day 1, Day 7 and Day 14.
Time frame: Day 1 up to Day 14
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 18-19 h | 63.34 bpm | Standard Deviation 11.705 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 0-1 h | 68.20 bpm | Standard Deviation 12.487 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 1-2 h | 68.84 bpm | Standard Deviation 14.022 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 2-3 h | 72.87 bpm | Standard Deviation 18.2 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 3-4 h | 68.69 bpm | Standard Deviation 14.133 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 4-5 h | 80.07 bpm | Standard Deviation 22.088 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 5-6 h | 90.46 bpm | Standard Deviation 17.075 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 6-7 h | 85.64 bpm | Standard Deviation 16.974 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 7-8 h | 81.67 bpm | Standard Deviation 16.306 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 8-9 h | 81.07 bpm | Standard Deviation 15.185 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 9-10 h | 79.38 bpm | Standard Deviation 16.201 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 10-11 h | 76.54 bpm | Standard Deviation 19.338 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 11-12 h | 74.33 bpm | Standard Deviation 17.192 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 12-13 h | 74.70 bpm | Standard Deviation 16.493 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 13-14 h | 70.17 bpm | Standard Deviation 16.547 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 14-15 h | 68.47 bpm | Standard Deviation 15.015 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 15-16 h | 67.30 bpm | Standard Deviation 13.618 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 16-17 h | 65.75 bpm | Standard Deviation 12.667 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 17-18 h | 64.20 bpm | Standard Deviation 12.078 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 19-20 h | 63.58 bpm | Standard Deviation 11.302 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 20-21 h | 68.81 bpm | Standard Deviation 13.465 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 21-22 h | 75.23 bpm | Standard Deviation 14.859 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 22-23 h | 75.08 bpm | Standard Deviation 15.643 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 23-24 h | 70.21 bpm | Standard Deviation 13.674 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 0-1 h | 73.97 bpm | Standard Deviation 12.115 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 1-2 h | 76.66 bpm | Standard Deviation 16.264 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 2-3 h | 74.21 bpm | Standard Deviation 16.735 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 3-4 h | 75.30 bpm | Standard Deviation 15.794 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 4-5 h | 83.21 bpm | Standard Deviation 12.349 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 5-6 h | 90.63 bpm | Standard Deviation 11.828 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 6-7 h | 90.50 bpm | Standard Deviation 17.096 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 7-8 h | 90.93 bpm | Standard Deviation 16.769 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 8-9 h | 85.50 bpm | Standard Deviation 12.923 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 9-10 h | 78.60 bpm | Standard Deviation 12.9 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 10-11 h | 78.80 bpm | Standard Deviation 12.846 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 11-12 h | 77.17 bpm | Standard Deviation 12.349 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 12-13 h | 74.47 bpm | Standard Deviation 16.722 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 13-14 h | 73.90 bpm | Standard Deviation 16.245 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 14-15 h | 67.97 bpm | Standard Deviation 14.851 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 15-16 h | 69.00 bpm | Standard Deviation 14.21 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 16-17 h | 66.47 bpm | Standard Deviation 13.97 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 17-18 h | 66.60 bpm | Standard Deviation 13.494 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 18-19 h | 65.27 bpm | Standard Deviation 14.732 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 19-20 h | 67.89 bpm | Standard Deviation 15.134 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 20-21 h | 69.75 bpm | Standard Deviation 15.978 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 21-22 h | 81.25 bpm | Standard Deviation 17.242 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 22-23 h | 78.27 bpm | Standard Deviation 17.026 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 23-24 h | 73.90 bpm | Standard Deviation 16.937 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 0-1 h | 72.58 bpm | Standard Deviation 13.911 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 1-2 h | 70.73 bpm | Standard Deviation 12.767 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 2-3 h | 69.30 bpm | Standard Deviation 15.013 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 3-4 h | 74.81 bpm | Standard Deviation 16.12 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 4-5 h | 83.09 bpm | Standard Deviation 18.12 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 5-6 h | 87.17 bpm | Standard Deviation 13.308 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 6-7 h | 81.62 bpm | Standard Deviation 11.162 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 7-8 h | 79.77 bpm | Standard Deviation 14.674 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 8-9 h | 79.97 bpm | Standard Deviation 13.84 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 9-10 h | 77.38 bpm | Standard Deviation 14.157 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 10-11 h | 81.14 bpm | Standard Deviation 11.396 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 11-12 h | 78.78 bpm | Standard Deviation 12.658 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 12-13 h | 76.53 bpm | Standard Deviation 12.925 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 13-14 h | 74.09 bpm | Standard Deviation 13.79 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 14-15 h | 71.41 bpm | Standard Deviation 14.672 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 15-16 h | 70.72 bpm | Standard Deviation 12.92 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 16-17 h | 69.16 bpm | Standard Deviation 11.226 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 17-18 h | 69.53 bpm | Standard Deviation 12.929 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 18-19 h | 66.72 bpm | Standard Deviation 10.807 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 19-20 h | 66.25 bpm | Standard Deviation 11.703 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 20-21 h | 72.56 bpm | Standard Deviation 16.361 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 21-22 h | 79.67 bpm | Standard Deviation 17.424 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 22-23 h | 77.15 bpm | Standard Deviation 14.389 |
| Placebo | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 23-24 h | 79.06 bpm | Standard Deviation 16.986 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 7-8 h | 77.10 bpm | Standard Deviation 15.826 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 18-19 h | 66.53 bpm | Standard Deviation 10.848 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 19-20 h | 63.31 bpm | Standard Deviation 9.889 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 20-21 h | 66.88 bpm | Standard Deviation 14.906 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 11-12 h | 74.60 bpm | Standard Deviation 11.558 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 21-22 h | 78.79 bpm | Standard Deviation 17.327 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 22-23 h | 74.10 bpm | Standard Deviation 11.235 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 23-24 h | 70.51 bpm | Standard Deviation 12.439 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 23-24 h | 67.82 bpm | Standard Deviation 11.478 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 0-1 h | 68.25 bpm | Standard Deviation 12.667 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 12-13 h | 71.40 bpm | Standard Deviation 14.023 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 1-2 h | 70.17 bpm | Standard Deviation 13.754 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 2-3 h | 65.96 bpm | Standard Deviation 13.524 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 3-4 h | 71.35 bpm | Standard Deviation 16.21 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 21-22 h | 70.73 bpm | Standard Deviation 13.157 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 4-5 h | 80.61 bpm | Standard Deviation 14.581 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 13-14 h | 71.33 bpm | Standard Deviation 13.282 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 5-6 h | 79.65 bpm | Standard Deviation 17.86 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 6-7 h | 78.07 bpm | Standard Deviation 13.867 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 7-8 h | 74.63 bpm | Standard Deviation 12.662 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 8-9 h | 76.53 bpm | Standard Deviation 14.341 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 14-15 h | 69.73 bpm | Standard Deviation 11.654 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 9-10 h | 75.73 bpm | Standard Deviation 14.007 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 10-11 h | 75.83 bpm | Standard Deviation 15.496 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 11-12 h | 73.61 bpm | Standard Deviation 12.435 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 12-13 h | 72.23 bpm | Standard Deviation 13.522 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 15-16 h | 68.87 bpm | Standard Deviation 12.238 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 13-14 h | 70.10 bpm | Standard Deviation 13.925 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 14-15 h | 70.10 bpm | Standard Deviation 13.288 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 15-16 h | 66.70 bpm | Standard Deviation 11.188 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 16-17 h | 65.60 bpm | Standard Deviation 10.524 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 16-17 h | 65.10 bpm | Standard Deviation 11.382 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 17-18 h | 65.57 bpm | Standard Deviation 10.962 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 18-19 h | 66.64 bpm | Standard Deviation 9.976 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 19-20 h | 67.17 bpm | Standard Deviation 11.047 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 22-23 h | 71.67 bpm | Standard Deviation 14.608 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 20-21 h | 67.35 bpm | Standard Deviation 15.498 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 17-18 h | 63.87 bpm | Standard Deviation 12.354 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 21-22 h | 70.39 bpm | Standard Deviation 14.987 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 22-23 h | 71.85 bpm | Standard Deviation 22.724 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 23-24 h | 69.51 bpm | Standard Deviation 10.521 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 0-1 h | 69.26 bpm | Standard Deviation 12.264 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 18-19 h | 64.60 bpm | Standard Deviation 12.689 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 1-2 h | 67.31 bpm | Standard Deviation 10.363 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 2-3 h | 69.00 bpm | Standard Deviation 13.952 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 3-4 h | 69.70 bpm | Standard Deviation 11.73 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 4-5 h | 76.30 bpm | Standard Deviation 15.787 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 19-20 h | 65.33 bpm | Standard Deviation 13.591 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 5-6 h | 76.63 bpm | Standard Deviation 13.348 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 6-7 h | 75.29 bpm | Standard Deviation 12.525 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 0-1 h | 68.38 bpm | Standard Deviation 11.616 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 1-2 h | 69.89 bpm | Standard Deviation 13.158 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 2-3 h | 66.83 bpm | Standard Deviation 14.839 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 3-4 h | 72.29 bpm | Standard Deviation 15.321 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 4-5 h | 74.82 bpm | Standard Deviation 17.671 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 5-6 h | 79.68 bpm | Standard Deviation 16.218 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 6-7 h | 78.23 bpm | Standard Deviation 17.37 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 7-8 h | 78.28 bpm | Standard Deviation 15.727 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 8-9 h | 77.03 bpm | Standard Deviation 13.345 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 8-9 h | 81.41 bpm | Standard Deviation 17.908 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 9-10 h | 79.31 bpm | Standard Deviation 16.239 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 10-11 h | 76.03 bpm | Standard Deviation 15.206 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 20-21 h | 68.31 bpm | Standard Deviation 16.095 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 11-12 h | 74.16 bpm | Standard Deviation 14.162 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 9-10 h | 80.21 bpm | Standard Deviation 18.824 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 12-13 h | 71.53 bpm | Standard Deviation 16.62 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 13-14 h | 71.00 bpm | Standard Deviation 13.837 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 14-15 h | 69.41 bpm | Standard Deviation 14.053 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 15-16 h | 66.69 bpm | Standard Deviation 14.791 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 10-11 h | 74.27 bpm | Standard Deviation 15.734 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 16-17 h | 65.75 bpm | Standard Deviation 12.031 |
| GW642444 100 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 17-18 h | 66.50 bpm | Standard Deviation 12.102 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 20-21 h | 71.17 bpm | Standard Deviation 15.336 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 12-13 h | 75.23 bpm | Standard Deviation 12.76 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 6-7 h | 76.54 bpm | Standard Deviation 12.801 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 13-14 h | 73.26 bpm | Standard Deviation 13.101 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 15-16 h | 71.62 bpm | Standard Deviation 12.805 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 14-15 h | 72.50 bpm | Standard Deviation 11.97 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 15-16 h | 71.98 bpm | Standard Deviation 10.818 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 23-24 h | 70.23 bpm | Standard Deviation 10.633 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 16-17 h | 70.83 bpm | Standard Deviation 10.822 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 14-15 h | 70.19 bpm | Standard Deviation 11.542 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 17-18 h | 70.75 bpm | Standard Deviation 12.194 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 16-17 h | 73.65 bpm | Standard Deviation 11.067 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 18-19 h | 69.07 bpm | Standard Deviation 10.887 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 8-9 h | 77.97 bpm | Standard Deviation 12.859 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 19-20 h | 68.86 bpm | Standard Deviation 13.388 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 8-9 h | 76.77 bpm | Standard Deviation 12.882 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 20-21 h | 68.39 bpm | Standard Deviation 14.531 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 9-10 h | 75.53 bpm | Standard Deviation 14.272 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 21-22 h | 75.08 bpm | Standard Deviation 18.779 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 17-18 h | 72.96 bpm | Standard Deviation 11.684 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 22-23 h | 72.96 bpm | Standard Deviation 13.181 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 23-24 h | 71.79 bpm | Standard Deviation 12.076 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 22-23 h | 75.58 bpm | Standard Deviation 10.004 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 10-11 h | 78.85 bpm | Standard Deviation 18.58 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 0-1 h | 71.43 bpm | Standard Deviation 12.365 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 10-11 h | 72.33 bpm | Standard Deviation 11.083 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 1-2 h | 73.09 bpm | Standard Deviation 14.935 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 18-19 h | 69.83 bpm | Standard Deviation 12.394 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 15-16 h | 68.27 bpm | Standard Deviation 13.843 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 2-3 h | 73.79 bpm | Standard Deviation 15.563 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 3-4 h | 72.72 bpm | Standard Deviation 11.496 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 11-12 h | 69.25 bpm | Standard Deviation 10.907 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 4-5 h | 77.08 bpm | Standard Deviation 12.802 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 5-6 h | 81.53 bpm | Standard Deviation 11.85 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 19-20 h | 67.59 bpm | Standard Deviation 11.334 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 17-18 h | 65.37 bpm | Standard Deviation 11.592 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 18-19 h | 67.82 bpm | Standard Deviation 17.133 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 12-13 h | 71.16 bpm | Standard Deviation 13.766 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 19-20 h | 70.86 bpm | Standard Deviation 19.586 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 0-1 h | 72.51 bpm | Standard Deviation 14.025 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 20-21 h | 70.82 bpm | Standard Deviation 17.638 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 6-7 h | 77.92 bpm | Standard Deviation 15.697 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 21-22 h | 71.47 bpm | Standard Deviation 18.402 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 11-12 h | 76.65 bpm | Standard Deviation 14.867 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 22-23 h | 70.37 bpm | Standard Deviation 10.167 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 1-2 h | 73.50 bpm | Standard Deviation 14.366 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 23-24 h | 69.63 bpm | Standard Deviation 12.911 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 0-1 h | 69.79 bpm | Standard Deviation 10.7 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 9-10 h | 77.65 bpm | Standard Deviation 16.831 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 2-3 h | 70.09 bpm | Standard Deviation 16.775 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 1-2 h | 72.63 bpm | Standard Deviation 12.989 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 12-13 h | 73.85 bpm | Standard Deviation 12.556 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 2-3 h | 69.89 bpm | Standard Deviation 14.077 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 3-4 h | 69.30 bpm | Standard Deviation 11.496 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 16-17 h | 67.87 bpm | Standard Deviation 11.999 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 3-4 h | 70.43 bpm | Standard Deviation 12.784 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 4-5 h | 78.96 bpm | Standard Deviation 12.857 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 7-8 h | 78.14 bpm | Standard Deviation 15.623 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 5-6 h | 79.12 bpm | Standard Deviation 15.687 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 13-14 h | 74.96 bpm | Standard Deviation 14.06 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 13-14 h | 70.50 bpm | Standard Deviation 11.54 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 6-7 h | 74.69 bpm | Standard Deviation 14.01 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 4-5 h | 77.72 bpm | Standard Deviation 13.937 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 7-8 h | 74.56 bpm | Standard Deviation 13.507 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 21-22 h | 79.31 bpm | Standard Deviation 17.59 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 8-9 h | 76.40 bpm | Standard Deviation 14.97 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 7-8 h | 76.32 bpm | Standard Deviation 15.363 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 9-10 h | 76.88 bpm | Standard Deviation 12.395 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 14-15 h | 74.78 bpm | Standard Deviation 13.677 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 5-6 h | 83.83 bpm | Standard Deviation 11.544 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 10-11 h | 79.63 bpm | Standard Deviation 15.493 |
| GW642444 400 mcg Once Daily | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 11-12 h | 75.55 bpm | Standard Deviation 13.549 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 13-14 h | 77.43 bpm | Standard Deviation 8.216 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 7-8 h | 77.67 bpm | Standard Deviation 13.774 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 2-3 h | 76.96 bpm | Standard Deviation 14.353 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 12-13 h | 81.47 bpm | Standard Deviation 9.021 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 9-10 h | 82.89 bpm | Standard Deviation 7.669 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 12-13 h | 80.54 bpm | Standard Deviation 8.434 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 18-19 h | 72.35 bpm | Standard Deviation 6.451 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 13-14 h | 80.37 bpm | Standard Deviation 8.423 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 10-11 h | 80.71 bpm | Standard Deviation 7.844 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 6-7 h | 81.46 bpm | Standard Deviation 11.896 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 19-20 h | 72.04 bpm | Standard Deviation 8.734 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 14-15 h | 80.37 bpm | Standard Deviation 8.943 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 15-16 h | 76.21 bpm | Standard Deviation 7.3 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 23-24 h | 78.39 bpm | Standard Deviation 16.352 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 10-11 h | 82.17 bpm | Standard Deviation 12.757 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 15-16 h | 75.80 bpm | Standard Deviation 8.988 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 19-20 h | 74.17 bpm | Standard Deviation 11.231 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 16-17 h | 73.84 bpm | Standard Deviation 8.408 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 20-21 h | 70.63 bpm | Standard Deviation 9.163 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 16-17 h | 74.73 bpm | Standard Deviation 9.243 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 7-8 h | 81.40 bpm | Standard Deviation 11.96 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 3-4 h | 77.71 bpm | Standard Deviation 14.097 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 9-10 h | 88.00 bpm | Standard Deviation 14.735 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 17-18 h | 74.23 bpm | Standard Deviation 8.542 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 20-21 h | 76.72 bpm | Standard Deviation 11.24 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 14-15 h | 77.41 bpm | Standard Deviation 7.912 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 0-1 h | 73.48 bpm | Standard Deviation 10.304 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 18-19 h | 74.10 bpm | Standard Deviation 10.369 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 16-17 h | 74.79 bpm | Standard Deviation 8.937 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 7-8 h | 81.15 bpm | Standard Deviation 13.423 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 14-15 h | 78.18 bpm | Standard Deviation 10.622 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 19-20 h | 73.47 bpm | Standard Deviation 9.066 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 8-9 h | 82.38 bpm | Standard Deviation 11.944 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 21-22 h | 82.03 bpm | Standard Deviation 13.237 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 4-5 h | 85.25 bpm | Standard Deviation 16.055 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 20-21 h | 75.12 bpm | Standard Deviation 13.67 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 21-22 h | 77.92 bpm | Standard Deviation 12.715 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 12-13 h | 80.17 bpm | Standard Deviation 11.182 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 3-4 h | 75.09 bpm | Standard Deviation 10.27 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 21-22 h | 81.10 bpm | Standard Deviation 18.165 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 22-23 h | 80.55 bpm | Standard Deviation 13.168 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 9-10 h | 82.94 bpm | Standard Deviation 11 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 11-12 h | 79.75 bpm | Standard Deviation 8.512 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 22-23 h | 83.00 bpm | Standard Deviation 16.501 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 17-18 h | 72.46 bpm | Standard Deviation 8.439 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 8-9 h | 81.17 bpm | Standard Deviation 10.069 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 4-5 h | 83.50 bpm | Standard Deviation 12.022 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 23-24 h | 76.50 bpm | Standard Deviation 12.89 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 5-6 h | 84.77 bpm | Standard Deviation 16.272 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 23-24 h | 76.94 bpm | Standard Deviation 12.137 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 1-2 h | 72.88 bpm | Standard Deviation 10.279 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 0-1 h | 71.31 bpm | Standard Deviation 11.094 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 6-7 h | 87.79 bpm | Standard Deviation 16.734 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 10-11 h | 81.88 bpm | Standard Deviation 10.888 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 5-6 h | 86.54 bpm | Standard Deviation 15.224 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 1-2 h | 79.42 bpm | Standard Deviation 14.377 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 0-1 h | 75.07 bpm | Standard Deviation 13.723 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 8-9 h | 81.57 bpm | Standard Deviation 15.587 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 11-12 h | 82.03 bpm | Standard Deviation 9.553 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 2-3 h | 80.38 bpm | Standard Deviation 11.531 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 18-19 h | 71.43 bpm | Standard Deviation 8.408 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 15-16 h | 75.00 bpm | Standard Deviation 8.828 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 13-14 h | 79.26 bpm | Standard Deviation 9.203 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 3-4 h | 77.95 bpm | Standard Deviation 10.489 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 22-23 h | 78.46 bpm | Standard Deviation 9.268 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 1-2 h | 74.05 bpm | Standard Deviation 12.343 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 6-7 h | 81.28 bpm | Standard Deviation 11.328 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 4-5 h | 81.46 bpm | Standard Deviation 13.089 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 11-12 h | 79.76 bpm | Standard Deviation 9.416 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 17-18 h | 72.00 bpm | Standard Deviation 8.823 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 2-3 h | 76.29 bpm | Standard Deviation 11.53 |
| Salmeterol 50 mcg BD | Mean Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 5-6 h | 89.15 bpm | Standard Deviation 14.899 |
Secondary
Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14
HR was measured using 28.5 h ABPM. The assessments for maximum HR were analyzed hourly as 0-1 h, 1-2 h, 2-3 h, 3-4 h, 4-5 h, 5-6 h, 6-7 h, 7-8 h, 8-9 h, 9-10 h, 10-11 h, 11-12 h, 12-13 h, 13-14 h, 14-15 h, 15-16 h, 16-17 h, 17-18 h, 18-19 h, 19-20 h, 20-21 h, 21-22 h, 22-23 h and 23-24 h at Day 1, Day 7 and Day 14.
Time frame: Day 1 up to Day 14
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 0-1 h | 70.6 bpm | Standard Deviation 13.01 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 1-2 h | 72.2 bpm | Standard Deviation 15.32 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 2-3 h | 75.8 bpm | Standard Deviation 19.33 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 3-4 h | 71.2 bpm | Standard Deviation 14.27 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 4-5 h | 84.6 bpm | Standard Deviation 22.67 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 5-6 h | 94.2 bpm | Standard Deviation 18.14 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 6-7 h | 89.6 bpm | Standard Deviation 18.9 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 7-8 h | 84.9 bpm | Standard Deviation 17.74 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 8-9 h | 85.0 bpm | Standard Deviation 17.26 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 9-10 h | 82.4 bpm | Standard Deviation 15.48 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 10-11 h | 78.7 bpm | Standard Deviation 19.8 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 11-12 h | 75.9 bpm | Standard Deviation 17.39 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 12-13 h | 77.3 bpm | Standard Deviation 17.59 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 13-14 h | 71.5 bpm | Standard Deviation 16.84 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 14-15 h | 69.7 bpm | Standard Deviation 14.69 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 15-16 h | 68.9 bpm | Standard Deviation 13.69 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 23-24 h | 72.6 bpm | Standard Deviation 12.87 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 16-17 h | 68.1 bpm | Standard Deviation 13.32 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 17-18 h | 65.6 bpm | Standard Deviation 11.67 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 18-19 h | 64.9 bpm | Standard Deviation 11.94 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 19-20 h | 65.5 bpm | Standard Deviation 12.14 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 20-21 h | 71.7 bpm | Standard Deviation 14.17 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 21-22 h | 77.6 bpm | Standard Deviation 15.88 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 22-23 h | 77.1 bpm | Standard Deviation 15.5 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 0-1 h | 78.4 bpm | Standard Deviation 12.21 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 1-2 h | 78.9 bpm | Standard Deviation 16.88 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 2-3 h | 75.5 bpm | Standard Deviation 16.7 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 3-4 h | 77.5 bpm | Standard Deviation 15.32 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 4-5 h | 88.8 bpm | Standard Deviation 13.85 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 5-6 h | 94.0 bpm | Standard Deviation 13.05 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 6-7 h | 92.5 bpm | Standard Deviation 16.78 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 7-8 h | 96.7 bpm | Standard Deviation 20.74 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 8-9 h | 89.2 bpm | Standard Deviation 12.96 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 9-10 h | 81.9 bpm | Standard Deviation 14.09 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 10-11 h | 83.2 bpm | Standard Deviation 13.12 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 11-12 h | 81.2 bpm | Standard Deviation 12.64 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 12-13 h | 77.2 bpm | Standard Deviation 17.63 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 13-14 h | 76.5 bpm | Standard Deviation 16.76 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 14-15 h | 69.4 bpm | Standard Deviation 15.55 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 15-16 h | 71.3 bpm | Standard Deviation 15.41 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 16-17 h | 68.3 bpm | Standard Deviation 15.42 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 17-18 h | 68.9 bpm | Standard Deviation 14.09 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 18-19 h | 66.3 bpm | Standard Deviation 14.8 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 19-20 h | 71.7 bpm | Standard Deviation 18.46 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 20-21 h | 77.1 bpm | Standard Deviation 16.13 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 21-22 h | 88.0 bpm | Standard Deviation 20.26 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 22-23 h | 79.9 bpm | Standard Deviation 18.3 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 23-24 h | 77.0 bpm | Standard Deviation 17.25 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 0-1 h | 75.9 bpm | Standard Deviation 15.22 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 1-2 h | 73.3 bpm | Standard Deviation 12.25 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 2-3 h | 71.5 bpm | Standard Deviation 15.13 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 3-4 h | 78.0 bpm | Standard Deviation 17.88 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 4-5 h | 87.1 bpm | Standard Deviation 16.8 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 5-6 h | 90.1 bpm | Standard Deviation 13.99 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 6-7 h | 84.8 bpm | Standard Deviation 9.97 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 7-8 h | 82.9 bpm | Standard Deviation 14.36 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 8-9 h | 82.5 bpm | Standard Deviation 14.33 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 9-10 h | 80.0 bpm | Standard Deviation 15.11 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 10-11 h | 84.4 bpm | Standard Deviation 11.6 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 11-112 h | 81.6 bpm | Standard Deviation 12.96 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 12-13 h | 79.8 bpm | Standard Deviation 15.21 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 13-14 h | 76.3 bpm | Standard Deviation 14.07 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 14-15 h | 73.3 bpm | Standard Deviation 14.92 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 15-16 h | 72.9 bpm | Standard Deviation 13.94 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 16-17 h | 70.8 bpm | Standard Deviation 11.48 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 17-18 h | 72.8 bpm | Standard Deviation 15.25 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 18-19 h | 69.1 bpm | Standard Deviation 11.03 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 19-20 h | 68.5 bpm | Standard Deviation 12.76 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 20-21 h | 75.1 bpm | Standard Deviation 17.38 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 21-22 h | 82.0 bpm | Standard Deviation 19.41 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 22-23 h | 79.8 bpm | Standard Deviation 14.88 |
| Placebo | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 23-24 h | 81.2 bpm | Standard Deviation 17.96 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 19-20 h | 66.9 bpm | Standard Deviation 14.52 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 12-13 h | 74.5 bpm | Standard Deviation 13.51 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 12-13 h | 73.4 bpm | Standard Deviation 17.79 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 5-6 h | 81.1 bpm | Standard Deviation 12.15 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 0-1 h | 71.4 bpm | Standard Deviation 13.82 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 13-14 h | 71.7 bpm | Standard Deviation 14.67 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 11-112 h | 75.9 bpm | Standard Deviation 12.31 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 4-5 h | 78.6 bpm | Standard Deviation 17.84 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 15-16 h | 70.7 bpm | Standard Deviation 13.11 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 14-15 h | 72.6 bpm | Standard Deviation 13.56 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 11-12 h | 75.9 bpm | Standard Deviation 14.9 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 3-4 h | 72.9 bpm | Standard Deviation 13.43 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 12-13 h | 74.7 bpm | Standard Deviation 14 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 15-16 h | 68.5 bpm | Standard Deviation 11.8 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 1-2 h | 73.0 bpm | Standard Deviation 15.46 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 2-3 h | 70.8 bpm | Standard Deviation 15.09 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 18-19 h | 67.1 bpm | Standard Deviation 14.08 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 16-17 h | 67.3 bpm | Standard Deviation 11.3 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 20-21 h | 71.3 bpm | Standard Deviation 17.68 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 1-2 h | 69.8 bpm | Standard Deviation 10.5 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 10-11 h | 78.9 bpm | Standard Deviation 17.02 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 17-18 h | 67.1 bpm | Standard Deviation 11.08 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 16-17 h | 67.6 bpm | Standard Deviation 12.1 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 0-1 h | 73.1 bpm | Standard Deviation 14.62 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 16-17 h | 66.3 bpm | Standard Deviation 11.78 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 18-19 h | 68.9 bpm | Standard Deviation 9.86 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 2-3 h | 67.2 bpm | Standard Deviation 13.83 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 23-24 h | 72.1 bpm | Standard Deviation 11.53 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 15-16 h | 68.9 bpm | Standard Deviation 17.61 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 19-20 h | 69.9 bpm | Standard Deviation 12.47 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 9-10 h | 82.2 bpm | Standard Deviation 15.71 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 22-23 h | 77.2 bpm | Standard Deviation 30.3 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 17-18 h | 65.4 bpm | Standard Deviation 12.55 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 20-21 h | 69.6 bpm | Standard Deviation 17.11 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 8-9 h | 78.6 bpm | Standard Deviation 14.21 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 21-22 h | 72.0 bpm | Standard Deviation 15.09 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 22-23 h | 74.0 bpm | Standard Deviation 14.39 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 3-4 h | 73.3 bpm | Standard Deviation 17.38 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 18-19 h | 70.9 bpm | Standard Deviation 13.15 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 8-9 h | 84.2 bpm | Standard Deviation 19.19 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 23-24 h | 70.1 bpm | Standard Deviation 11.82 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 4-5 h | 87.8 bpm | Standard Deviation 18.56 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 21-22 h | 85.0 bpm | Standard Deviation 25.45 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 7-8 h | 84.5 bpm | Standard Deviation 19.89 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 13-14 h | 73.3 bpm | Standard Deviation 14.41 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 5-6 h | 82.1 bpm | Standard Deviation 17.81 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 19-20 h | 64.7 bpm | Standard Deviation 10.82 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 6-7 h | 80.5 bpm | Standard Deviation 17.73 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 20-21 h | 72.5 bpm | Standard Deviation 20.28 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 6-7 h | 85.4 bpm | Standard Deviation 15.58 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 14-15 h | 70.8 bpm | Standard Deviation 14.61 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 5-6 h | 82.3 bpm | Standard Deviation 16.45 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 7-8 h | 81.5 bpm | Standard Deviation 17.22 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 7-8 h | 77.9 bpm | Standard Deviation 13.02 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 22-23 h | 79.5 bpm | Standard Deviation 15.12 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 4-5 h | 78.0 bpm | Standard Deviation 18.81 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 21-22 h | 72.9 bpm | Standard Deviation 13.44 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 8-9 h | 78.5 bpm | Standard Deviation 15.27 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 17-18 h | 68.9 bpm | Standard Deviation 13.3 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 3-4 h | 74.4 bpm | Standard Deviation 15.9 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 14-15 h | 71.9 bpm | Standard Deviation 11.68 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 9-10 h | 77.5 bpm | Standard Deviation 13.84 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 13-14 h | 72.4 bpm | Standard Deviation 14.33 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 2-3 h | 70.1 bpm | Standard Deviation 17.21 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 1-2 h | 72.8 bpm | Standard Deviation 16.72 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 10-11 h | 78.5 bpm | Standard Deviation 17.13 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 23-24 h | 72.1 bpm | Standard Deviation 12.83 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 6-7 h | 77.8 bpm | Standard Deviation 12.97 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 10-11 h | 76.3 bpm | Standard Deviation 15.94 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 11-12 h | 75.3 bpm | Standard Deviation 12.58 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 9-10 h | 83.6 bpm | Standard Deviation 19.68 |
| GW642444 100 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 0-1 h | 71.1 bpm | Standard Deviation 12.33 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 17-18 h | 67.0 bpm | Standard Deviation 11.47 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 18-19 h | 70.4 bpm | Standard Deviation 17.35 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 20-21 h | 73.3 bpm | Standard Deviation 14.81 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 19-20 h | 73.8 bpm | Standard Deviation 19.57 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 20-21 h | 72.6 bpm | Standard Deviation 18.91 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 11-112 h | 78.6 bpm | Standard Deviation 15.41 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 21-22 h | 72.7 bpm | Standard Deviation 19.6 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 22-23 h | 71.9 bpm | Standard Deviation 10.79 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 23-24 h | 71.7 bpm | Standard Deviation 12.59 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 0-1 h | 73.2 bpm | Standard Deviation 12.13 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 1-2 h | 75.5 bpm | Standard Deviation 13.53 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 12-13 h | 76.5 bpm | Standard Deviation 13.4 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 2-3 h | 71.4 bpm | Standard Deviation 14.32 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 3-4 h | 71.0 bpm | Standard Deviation 11.78 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 4-5 h | 83.1 bpm | Standard Deviation 18.52 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 5-6 h | 80.7 bpm | Standard Deviation 16.52 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 13-14 h | 77.1 bpm | Standard Deviation 16.06 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 6-7 h | 76.6 bpm | Standard Deviation 13.91 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 7-8 h | 77.6 bpm | Standard Deviation 16.31 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 8-9 h | 77.8 bpm | Standard Deviation 15.41 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 9-10 h | 80.0 bpm | Standard Deviation 13.27 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 10-11 h | 83.1 bpm | Standard Deviation 16.04 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 14-15 h | 77.1 bpm | Standard Deviation 14.58 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 11-12 h | 77.2 bpm | Standard Deviation 14.04 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 12-13 h | 77.3 bpm | Standard Deviation 13.33 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 21-22 h | 81.8 bpm | Standard Deviation 17.49 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 13-14 h | 75.6 bpm | Standard Deviation 14.16 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 14-15 h | 74.4 bpm | Standard Deviation 12.64 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 15-16 h | 74.1 bpm | Standard Deviation 14.21 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 15-16 h | 74.0 bpm | Standard Deviation 11.31 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 16-17 h | 73.4 bpm | Standard Deviation 11.95 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 23-24 h | 71.5 bpm | Standard Deviation 10.64 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 17-18 h | 72.7 bpm | Standard Deviation 13.78 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 18-19 h | 72.5 bpm | Standard Deviation 12.4 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 16-17 h | 76.1 bpm | Standard Deviation 11.97 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 19-20 h | 71.2 bpm | Standard Deviation 13.45 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 20-21 h | 70.9 bpm | Standard Deviation 15.08 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 21-22 h | 79.1 bpm | Standard Deviation 22.11 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 22-23 h | 74.9 bpm | Standard Deviation 13.45 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 17-18 h | 75.4 bpm | Standard Deviation 12.27 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 23-24 h | 73.8 bpm | Standard Deviation 11.45 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 0-1 h | 72.8 bpm | Standard Deviation 13.24 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 22-23 h | 79.8 bpm | Standard Deviation 8.92 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 1-2 h | 77.6 bpm | Standard Deviation 16.51 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 2-3 h | 75.8 bpm | Standard Deviation 17.29 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 18-19 h | 71.6 bpm | Standard Deviation 12.67 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 3-4 h | 75.4 bpm | Standard Deviation 11.35 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 4-5 h | 81.5 bpm | Standard Deviation 22.85 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 5-6 h | 84.3 bpm | Standard Deviation 11.71 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 0-1 h | 74.4 bpm | Standard Deviation 15.08 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 1-2 h | 76.4 bpm | Standard Deviation 16.21 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 6-7 h | 79.6 bpm | Standard Deviation 16.19 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 2-3 h | 71.8 bpm | Standard Deviation 17.31 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 3-4 h | 72.8 bpm | Standard Deviation 12.69 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 19-20 h | 68.8 bpm | Standard Deviation 11.45 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 4-5 h | 81.6 bpm | Standard Deviation 14.4 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 5-6 h | 86.4 bpm | Standard Deviation 11.38 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 7-8 h | 79.1 bpm | Standard Deviation 16.53 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 6-7 h | 78.9 bpm | Standard Deviation 13.44 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 7-8 h | 80.2 bpm | Standard Deviation 16.38 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 8-9 h | 81.1 bpm | Standard Deviation 13.49 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 9-10 h | 77.3 bpm | Standard Deviation 14.85 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 8-9 h | 78.8 bpm | Standard Deviation 13.74 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 10-11 h | 74.1 bpm | Standard Deviation 11.79 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 11-12 h | 71.3 bpm | Standard Deviation 12 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 12-13 h | 74.3 bpm | Standard Deviation 17.66 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 13-14 h | 72.7 bpm | Standard Deviation 12.04 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 9-10 h | 80.2 bpm | Standard Deviation 16.58 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 14-15 h | 71.8 bpm | Standard Deviation 12.41 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 15-16 h | 69.2 bpm | Standard Deviation 13.96 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 16-17 h | 70.9 bpm | Standard Deviation 13.24 |
| GW642444 400 mcg Once Daily | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 10-11 h | 81.2 bpm | Standard Deviation 19.62 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 14-15 h | 79.9 bpm | Standard Deviation 11.16 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 11-12 h | 83.6 bpm | Standard Deviation 9.63 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 20-21 h | 72.8 bpm | Standard Deviation 10.21 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 0-1 h | 76.6 bpm | Standard Deviation 10.98 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 10-11 h | 84.6 bpm | Standard Deviation 13.56 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 21-22 h | 81.4 bpm | Standard Deviation 15.05 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 19-20 h | 77.2 bpm | Standard Deviation 13.61 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 1-2 h | 74.1 bpm | Standard Deviation 10.19 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 12-13 h | 83.0 bpm | Standard Deviation 12.34 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 9-10 h | 91.2 bpm | Standard Deviation 16.05 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 23-24 h | 79.1 bpm | Standard Deviation 12.78 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 2-3 h | 78.6 bpm | Standard Deviation 12.08 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 6-7 h | 88.8 bpm | Standard Deviation 16.61 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 8-9 h | 84.1 bpm | Standard Deviation 17.28 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 22-23 h | 82.9 bpm | Standard Deviation 14.73 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 3-4 h | 78.2 bpm | Standard Deviation 11.11 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 18-19 h | 75.7 bpm | Standard Deviation 7.54 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 7-8 h | 83.9 bpm | Standard Deviation 14.41 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 13-14 h | 81.4 bpm | Standard Deviation 10.35 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 4-5 h | 86.4 bpm | Standard Deviation 12.91 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 13-14 h | 80.0 bpm | Standard Deviation 7.62 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 6-7 h | 83.8 bpm | Standard Deviation 12.81 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 10-11 h | 82.8 bpm | Standard Deviation 7.9 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 5-6 h | 88.5 bpm | Standard Deviation 18.88 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 11-112 h | 81.5 bpm | Standard Deviation 8.69 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 5-6 h | 88.8 bpm | Standard Deviation 16.11 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 16-17 h | 76.2 bpm | Standard Deviation 9.06 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 6-7 h | 83.1 bpm | Standard Deviation 12.07 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 7-8 h | 80.2 bpm | Standard Deviation 14.88 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 4-5 h | 88.8 bpm | Standard Deviation 15.42 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 14-15 h | 79.8 bpm | Standard Deviation 7.82 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 7-8 h | 84.4 bpm | Standard Deviation 13.92 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 19-20 h | 73.9 bpm | Standard Deviation 8.53 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 3-4 h | 80.0 bpm | Standard Deviation 14.22 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 9-10 h | 85.5 bpm | Standard Deviation 8.06 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 8-9 h | 85.1 bpm | Standard Deviation 13.11 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 12-13 h | 82.6 bpm | Standard Deviation 9.41 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 20-21 h | 76.5 bpm | Standard Deviation 13.96 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 2-3 h | 77.9 bpm | Standard Deviation 14.93 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 21-22 h | 83.5 bpm | Standard Deviation 17.91 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 16-17 h | 77.4 bpm | Standard Deviation 10.28 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 19-20 h | 75.3 bpm | Standard Deviation 9.36 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 21-22 h | 84.3 bpm | Standard Deviation 14.31 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 22-23 h | 86.2 bpm | Standard Deviation 16.3 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 9-10 h | 84.6 bpm | Standard Deviation 11.7 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 18-19 h | 76.3 bpm | Standard Deviation 11.03 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 20-21 h | 79.9 bpm | Standard Deviation 12.54 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 23-24 h | 78.0 bpm | Standard Deviation 13.19 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 17-18 h | 73.8 bpm | Standard Deviation 8.49 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 17-18 h | 75.7 bpm | Standard Deviation 9.43 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 1-2 h | 74.8 bpm | Standard Deviation 12.3 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 0-1 h | 74.2 bpm | Standard Deviation 9.69 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 17-18 h | 74.2 bpm | Standard Deviation 9.28 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 16-17 h | 76.7 bpm | Standard Deviation 8.67 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 10-11 h | 84.4 bpm | Standard Deviation 12.47 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 1-2 h | 81.7 bpm | Standard Deviation 15.38 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 15-16 h | 78.0 bpm | Standard Deviation 7.81 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 15-16 h | 77.1 bpm | Standard Deviation 8.83 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 8-9 h | 82.4 bpm | Standard Deviation 9.98 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 2-3 h | 81.6 bpm | Standard Deviation 11.05 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 0-1 h | 77.2 bpm | Standard Deviation 14.04 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 14-15 h | 83.2 bpm | Standard Deviation 10.35 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 15-16 h | 76.1 bpm | Standard Deviation 8.84 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 3-4 h | 79.1 bpm | Standard Deviation 11.09 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 18-19 h | 73.5 bpm | Standard Deviation 8.92 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 13-14 h | 82.1 bpm | Standard Deviation 9.38 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 1, 11-12 h | 82.0 bpm | Standard Deviation 9.87 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 4-5 h | 83.9 bpm | Standard Deviation 13.79 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 22-23 h | 81.4 bpm | Standard Deviation 10.13 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 7, 12-13 h | 83.4 bpm | Standard Deviation 8.86 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 23-24 h | 83.2 bpm | Standard Deviation 22.59 |
| Salmeterol 50 mcg BD | Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14 | Day 14, 5-6 h | 91.7 bpm | Standard Deviation 14.65 |
Secondary
Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time
PEF is a measure of lung function and measures how fast a person can breathe out. It was measured using a peak flow meter by the participants and recorded on daily record cards each day in the morning and evening from Screening up to Follow-up. The morning measurements were performed prior to the participant taking the morning dose of study medication or rescue medication. The evening measurements were performed prior to the participant taking the evening dose of study medication or rescue medication. The highest of the 3 values of morning and evening PEF were recorded on the diary card. The mean of 7 days of each morning and evening measurements were reported for the Run-in Week, Week 1, Week 2 and Follow-up.
Time frame: Up to Follow-up (Day 17)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Morning PEFR, Run-in | 268.20 Liters per minute (L/min) | Standard Deviation 85.986 |
| Placebo | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Morning PEFR, Week 1 | 271.37 Liters per minute (L/min) | Standard Deviation 85.186 |
| Placebo | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Morning PEFR, Week 2 | 264.52 Liters per minute (L/min) | Standard Deviation 89.793 |
| Placebo | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Morning PEFR, Follow-up | 270.16 Liters per minute (L/min) | Standard Deviation 95.536 |
| Placebo | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Evening PEFR, Run-in | 266.76 Liters per minute (L/min) | Standard Deviation 79.352 |
| Placebo | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Evening PEFR, Week 1 | 273.45 Liters per minute (L/min) | Standard Deviation 82.356 |
| Placebo | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Evening PEFR, Week 2 | 274.13 Liters per minute (L/min) | Standard Deviation 84.622 |
| Placebo | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Evening PEFR, Follow-up | 284.75 Liters per minute (L/min) | Standard Deviation 84.68 |
| GW642444 100 mcg Once Daily | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Evening PEFR, Week 1 | 278.80 Liters per minute (L/min) | Standard Deviation 65.325 |
| GW642444 100 mcg Once Daily | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Evening PEFR, Run-in | 251.85 Liters per minute (L/min) | Standard Deviation 63.927 |
| GW642444 100 mcg Once Daily | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Morning PEFR, Week 1 | 266.22 Liters per minute (L/min) | Standard Deviation 61.112 |
| GW642444 100 mcg Once Daily | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Evening PEFR, Follow-up | 262.14 Liters per minute (L/min) | Standard Deviation 55.737 |
| GW642444 100 mcg Once Daily | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Evening PEFR, Week 2 | 275.12 Liters per minute (L/min) | Standard Deviation 59.122 |
| GW642444 100 mcg Once Daily | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Morning PEFR, Follow-up | 262.83 Liters per minute (L/min) | Standard Deviation 55.709 |
| GW642444 100 mcg Once Daily | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Morning PEFR, Week 2 | 265.23 Liters per minute (L/min) | Standard Deviation 66.178 |
| GW642444 100 mcg Once Daily | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Morning PEFR, Run-in | 249.99 Liters per minute (L/min) | Standard Deviation 78.848 |
| GW642444 400 mcg Once Daily | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Evening PEFR, Week 2 | 302.04 Liters per minute (L/min) | Standard Deviation 110.097 |
| GW642444 400 mcg Once Daily | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Morning PEFR, Week 2 | 295.75 Liters per minute (L/min) | Standard Deviation 106.748 |
| GW642444 400 mcg Once Daily | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Morning PEFR, Follow-up | 297.69 Liters per minute (L/min) | Standard Deviation 111.329 |
| GW642444 400 mcg Once Daily | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Evening PEFR, Run-in | 270.10 Liters per minute (L/min) | Standard Deviation 93.699 |
| GW642444 400 mcg Once Daily | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Evening PEFR, Week 1 | 311.46 Liters per minute (L/min) | Standard Deviation 99.984 |
| GW642444 400 mcg Once Daily | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Evening PEFR, Follow-up | 319.09 Liters per minute (L/min) | Standard Deviation 110.336 |
| GW642444 400 mcg Once Daily | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Morning PEFR, Run-in | 276.45 Liters per minute (L/min) | Standard Deviation 95.245 |
| GW642444 400 mcg Once Daily | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Morning PEFR, Week 1 | 299.22 Liters per minute (L/min) | Standard Deviation 99.017 |
| Salmeterol 50 mcg BD | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Morning PEFR, Week 2 | 257.84 Liters per minute (L/min) | Standard Deviation 74.086 |
| Salmeterol 50 mcg BD | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Morning PEFR, Follow-up | 264.64 Liters per minute (L/min) | Standard Deviation 83.106 |
| Salmeterol 50 mcg BD | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Morning PEFR, Week 1 | 254.39 Liters per minute (L/min) | Standard Deviation 63.273 |
| Salmeterol 50 mcg BD | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Morning PEFR, Run-in | 244.44 Liters per minute (L/min) | Standard Deviation 52.722 |
| Salmeterol 50 mcg BD | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Evening PEFR, Run-in | 252.64 Liters per minute (L/min) | Standard Deviation 66.592 |
| Salmeterol 50 mcg BD | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Evening PEFR, Follow-up | 314.44 Liters per minute (L/min) | Standard Deviation 99.858 |
| Salmeterol 50 mcg BD | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Evening PEFR, Week 2 | 263.01 Liters per minute (L/min) | Standard Deviation 88.672 |
| Salmeterol 50 mcg BD | Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time | Evening PEFR, Week 1 | 264.45 Liters per minute (L/min) | Standard Deviation 78.755 |
Secondary
Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time
A holter monitor is a machine that continuously records the heart's electrical activity. A 3-lead holter ECG monitoring device was used. The monitor was worn for 24 h during normal activity to record the ECG intervals. The assesmment for hourly maximums QTcF and QTcB was done on Day 1, Day 7 and Day 14. For each h of holter monitoring the maximum QTcF for that h was calculated using the maximum QT and mean HR of that given h as Maximum QT divided by (60/Mean HR)\^1/3. For each h of holter monitoring the maximum QTcB for that h was calculated using the maximum QT and mean HR of that given h as Maximum QT divided by (60/Mean HR)\^1/2.
Time frame: Day 1 up to Day 14
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 1, QTcF | 474.2567 msec | Standard Deviation 26.91319 |
| Placebo | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 7, QTcF | 471.3443 msec | Standard Deviation 17.96397 |
| Placebo | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 14, QTcF | 471.3571 msec | Standard Deviation 14.87705 |
| Placebo | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 1, QTcB | 491.2731 msec | Standard Deviation 32.55948 |
| Placebo | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 7, QTcB | 491.1749 msec | Standard Deviation 21.97287 |
| Placebo | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 14, QTcB | 489.5294 msec | Standard Deviation 18.51699 |
| GW642444 100 mcg Once Daily | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 14, QTcB | 494.0542 msec | Standard Deviation 23.18669 |
| GW642444 100 mcg Once Daily | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 1, QTcB | 486.3962 msec | Standard Deviation 21.76741 |
| GW642444 100 mcg Once Daily | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 1, QTcF | 470.3755 msec | Standard Deviation 21.522 |
| GW642444 100 mcg Once Daily | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 14, QTcF | 478.8226 msec | Standard Deviation 20.29032 |
| GW642444 100 mcg Once Daily | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 7, QTcF | 470.9166 msec | Standard Deviation 18.10351 |
| GW642444 100 mcg Once Daily | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 7, QTcB | 486.1238 msec | Standard Deviation 22.36925 |
| GW642444 400 mcg Once Daily | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 7, QTcF | 471.2125 msec | Standard Deviation 30.75404 |
| GW642444 400 mcg Once Daily | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 14, QTcF | 461.4473 msec | Standard Deviation 32.41893 |
| GW642444 400 mcg Once Daily | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 1, QTcB | 484.1421 msec | Standard Deviation 31.72641 |
| GW642444 400 mcg Once Daily | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 14, QTcB | 479.8827 msec | Standard Deviation 36.11264 |
| GW642444 400 mcg Once Daily | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 7, QTcB | 488.0985 msec | Standard Deviation 33.5283 |
| GW642444 400 mcg Once Daily | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 1, QTcF | 468.4990 msec | Standard Deviation 28.95477 |
| Salmeterol 50 mcg BD | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 7, QTcB | 493.4279 msec | Standard Deviation 19.59523 |
| Salmeterol 50 mcg BD | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 14, QTcB | 484.5300 msec | Standard Deviation 16.67519 |
| Salmeterol 50 mcg BD | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 7, QTcF | 469.7194 msec | Standard Deviation 17.22701 |
| Salmeterol 50 mcg BD | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 1, QTcB | 493.5255 msec | Standard Deviation 21.80365 |
| Salmeterol 50 mcg BD | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 1, QTcF | 470.6075 msec | Standard Deviation 20.80669 |
| Salmeterol 50 mcg BD | Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time | Day 14, QTcF | 462.4090 msec | Standard Deviation 18.50928 |
Secondary
Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time
A 12-lead ECG was recorded on Day 1, 2, 7, 8, 14 and 15 with the participant in a supine position having rested in that position for at least 5 min before each reading. A total of 3 measurements separated by at least 1 min was taken at each visit and the mean recorded. The pre-dose QTcF and QTcB assessment was done at Day 1, 7 and 14. Weighted mean at 0-4 h for QTcF and QTcB at Day 1, 2, 7, 8, 14 and 15 was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The maximum QTcF and QTcB at 0-4 h was obtained at Day 1, 2, 7, 8, 14 and 15.
Time frame: Day 1 up to Day 15
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Day 7, pre-dose | 407.380 msec | Standard Deviation 17.7924 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Day 1, pre-dose | 405.222 msec | Standard Deviation 20.8892 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 15 | 397.8727 msec | Standard Deviation 16.14803 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 14 | 413.498 msec | Standard Deviation 16.8864 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 15 | 403.337 msec | Standard Deviation 16.964 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 14 | 405.360 msec | Standard Deviation 13.6156 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 1 | 402.656 msec | Standard Deviation 20.3503 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 2 | 411.686 msec | Standard Deviation 21.7606 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 8 | 402.412 msec | Standard Deviation 17.9804 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 7 | 405.069 msec | Standard Deviation 16.23 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 2 | 404.885 msec | Standard Deviation 21.1074 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 1 | 409.821 msec | Standard Deviation 20.9888 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 1 | 399.1571 msec | Standard Deviation 20.93784 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Day 7, pre-dose | 398.828 msec | Standard Deviation 14.5763 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 15 | 406.8096 msec | Standard Deviation 20.18685 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Day 1, pre-dose | 396.518 msec | Standard Deviation 18.9384 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 2 | 399.0984 msec | Standard Deviation 20.7643 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 15 | 413.202 msec | Standard Deviation 22.381 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 14 | 409.5049 msec | Standard Deviation 18.03324 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 8 | 404.3968 msec | Standard Deviation 22.29983 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 7 | 397.6228 msec | Standard Deviation 13.80395 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 8 | 411.486 msec | Standard Deviation 23.276 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 7 | 405.1001 msec | Standard Deviation 14.3221 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 2 | 405.7239 msec | Standard Deviation 21.67872 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 8 | 397.3716 msec | Standard Deviation 18.94814 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 7 | 416.155 msec | Standard Deviation 18.5802 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 1 | 405.1192 msec | Standard Deviation 22.7229 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Day 14, pre-dose | 409.909 msec | Standard Deviation 19.5835 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 14 | 399.8488 msec | Standard Deviation 13.18337 |
| Placebo | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Day 14, pre-dose | 399.599 msec | Standard Deviation 14.8681 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 14 | 405.7653 msec | Standard Deviation 22.29165 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Day 1, pre-dose | 397.667 msec | Standard Deviation 17.9057 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Day 7, pre-dose | 403.565 msec | Standard Deviation 23.5668 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Day 14, pre-dose | 397.184 msec | Standard Deviation 20.8546 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 1 | 398.9213 msec | Standard Deviation 18.95805 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 2 | 402.0399 msec | Standard Deviation 18.98919 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 7 | 402.8639 msec | Standard Deviation 23.36556 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 8 | 396.6669 msec | Standard Deviation 19.88573 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 14 | 400.2724 msec | Standard Deviation 19.00353 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 15 | 397.0283 msec | Standard Deviation 20.64521 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 1 | 405.766 msec | Standard Deviation 20.3313 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 2 | 406.526 msec | Standard Deviation 19.2241 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 7 | 407.985 msec | Standard Deviation 24.5587 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 8 | 402.833 msec | Standard Deviation 19.0273 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 14 | 406.050 msec | Standard Deviation 20.5479 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 15 | 400.653 msec | Standard Deviation 18.6693 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Day 1, pre-dose | 402.023 msec | Standard Deviation 22.2404 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Day 7, pre-dose | 408.688 msec | Standard Deviation 24.8189 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Day 14, pre-dose | 402.505 msec | Standard Deviation 25.5206 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 1 | 403.9471 msec | Standard Deviation 22.1054 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 2 | 406.5243 msec | Standard Deviation 19.43633 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 7 | 407.8107 msec | Standard Deviation 24.03156 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 8 | 401.5862 msec | Standard Deviation 24.75626 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 15 | 402.4642 msec | Standard Deviation 25.07009 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 1 | 411.925 msec | Standard Deviation 22.5302 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 2 | 412.820 msec | Standard Deviation 20.3513 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 7 | 414.540 msec | Standard Deviation 22.8711 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 8 | 407.963 msec | Standard Deviation 22.5265 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 14 | 411.906 msec | Standard Deviation 22.075 |
| GW642444 100 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 15 | 408.224 msec | Standard Deviation 23.3075 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 14 | 409.9818 msec | Standard Deviation 19.36717 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 14 | 400.0939 msec | Standard Deviation 20.11137 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 1 | 396.4321 msec | Standard Deviation 23.12234 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 15 | 418.093 msec | Standard Deviation 18.7721 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 15 | 410.0328 msec | Standard Deviation 18.49302 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Day 7, pre-dose | 396.804 msec | Standard Deviation 19.9587 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 8 | 420.074 msec | Standard Deviation 17.7199 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 14 | 418.858 msec | Standard Deviation 20.5848 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 1 | 412.289 msec | Standard Deviation 22.9219 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 2 | 409.0807 msec | Standard Deviation 23.78119 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Day 14, pre-dose | 392.524 msec | Standard Deviation 24.7455 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Day 14, pre-dose | 398.524 msec | Standard Deviation 21.6747 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 2 | 407.950 msec | Standard Deviation 23.4527 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 7 | 401.0754 msec | Standard Deviation 24.39809 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Day 1, pre-dose | 396.975 msec | Standard Deviation 24.1244 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 2 | 416.821 msec | Standard Deviation 24.7489 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 7 | 407.113 msec | Standard Deviation 24.2679 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 7 | 408.3410 msec | Standard Deviation 20.23969 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 1 | 402.468 msec | Standard Deviation 22.2225 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 8 | 401.0157 msec | Standard Deviation 22.8035 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 8 | 407.671 msec | Standard Deviation 21.7779 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Day 7, pre-dose | 401.221 msec | Standard Deviation 16.6437 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 1 | 404.2282 msec | Standard Deviation 23.22646 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 8 | 410.3044 msec | Standard Deviation 20.92796 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 14 | 407.790 msec | Standard Deviation 20.6278 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 2 | 401.8953 msec | Standard Deviation 23.15689 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 15 | 400.4180 msec | Standard Deviation 19.18469 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Day 1, pre-dose | 391.300 msec | Standard Deviation 23.3733 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 15 | 406.773 msec | Standard Deviation 19.4447 |
| GW642444 400 mcg Once Daily | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 7 | 417.478 msec | Standard Deviation 21.5061 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 15 | 399.910 msec | Standard Deviation 17.158 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Day 1, pre-dose | 406.463 msec | Standard Deviation 21.3658 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 7 | 415.172 msec | Standard Deviation 20.2556 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Day 7, pre-dose | 409.064 msec | Standard Deviation 19.5591 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 8 | 393.4643 msec | Standard Deviation 19.93914 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Day 14, pre-dose | 403.905 msec | Standard Deviation 15.6393 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 15 | 413.501 msec | Standard Deviation 14.6549 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 8 | 406.2555 msec | Standard Deviation 20.3 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 1 | 408.8990 msec | Standard Deviation 21.51019 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 7 | 395.9180 msec | Standard Deviation 19.47963 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 2 | 411.1034 msec | Standard Deviation 18.9991 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 8 | 413.107 msec | Standard Deviation 18.3979 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 7 | 408.9141 msec | Standard Deviation 21.56424 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 2 | 397.3482 msec | Standard Deviation 17.29841 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Day 1, pre-dose | 396.361 msec | Standard Deviation 16.7847 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 1 | 396.6588 msec | Standard Deviation 18.71828 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 14 | 408.2043 msec | Standard Deviation 20.4932 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Weighted mean 0-4 h, Day 15 | 406.7532 msec | Standard Deviation 16.53736 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Day 14, pre-dose | 393.522 msec | Standard Deviation 15.5437 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 1 | 414.910 msec | Standard Deviation 20.9889 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 14 | 411.843 msec | Standard Deviation 18.6525 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 2 | 400.844 msec | Standard Deviation 18.8346 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 1 | 402.696 msec | Standard Deviation 16.6072 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 7 | 400.665 msec | Standard Deviation 18.8396 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcB, Maximum 0-4 h, Day 2 | 414.524 msec | Standard Deviation 21.3863 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 8 | 398.618 msec | Standard Deviation 20.0406 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 15 | 392.3686 msec | Standard Deviation 16.99407 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Day 7, pre-dose | 396.897 msec | Standard Deviation 16.834 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Maximum 0-4 h, Day 14 | 398.931 msec | Standard Deviation 18.9056 |
| Salmeterol 50 mcg BD | Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time | QTcF, Weighted mean 0-4 h, Day 14 | 395.5983 msec | Standard Deviation 19.45327 |
Secondary
Mean Use of Rescue Medication Over Period
Ipratropium bromide was provided as the rescue medication. The use of rescue medication was recorded by the participants on daily record cards each day in the morning and evening from Screening up to Follow-up. The mean of 7 days (puffs per 24 h) were reported for the Run-in Week, Week 1, Week 2 and Follow-up.
Time frame: Up to Follow-up (Day 17)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Use of Rescue Medication Over Period | Run-in | 3.12 Puffs per 24 h | Standard Deviation 2.525 |
| Placebo | Mean Use of Rescue Medication Over Period | Week 1 | 1.99 Puffs per 24 h | Standard Deviation 2.453 |
| Placebo | Mean Use of Rescue Medication Over Period | Week 2 | 2.24 Puffs per 24 h | Standard Deviation 3.053 |
| Placebo | Mean Use of Rescue Medication Over Period | Follow-up | 2.17 Puffs per 24 h | Standard Deviation 2.552 |
| GW642444 100 mcg Once Daily | Mean Use of Rescue Medication Over Period | Week 1 | 1.63 Puffs per 24 h | Standard Deviation 1.755 |
| GW642444 100 mcg Once Daily | Mean Use of Rescue Medication Over Period | Week 2 | 1.61 Puffs per 24 h | Standard Deviation 2.021 |
| GW642444 100 mcg Once Daily | Mean Use of Rescue Medication Over Period | Follow-up | 1.38 Puffs per 24 h | Standard Deviation 1.502 |
| GW642444 100 mcg Once Daily | Mean Use of Rescue Medication Over Period | Run-in | 2.46 Puffs per 24 h | Standard Deviation 2.464 |
| GW642444 400 mcg Once Daily | Mean Use of Rescue Medication Over Period | Week 2 | 0.79 Puffs per 24 h | Standard Deviation 1.159 |
| GW642444 400 mcg Once Daily | Mean Use of Rescue Medication Over Period | Week 1 | 0.73 Puffs per 24 h | Standard Deviation 1.133 |
| GW642444 400 mcg Once Daily | Mean Use of Rescue Medication Over Period | Follow-up | 1.11 Puffs per 24 h | Standard Deviation 1.364 |
| GW642444 400 mcg Once Daily | Mean Use of Rescue Medication Over Period | Run-in | 1.38 Puffs per 24 h | Standard Deviation 1.554 |
| Salmeterol 50 mcg BD | Mean Use of Rescue Medication Over Period | Follow-up | 0.86 Puffs per 24 h | Standard Deviation 1.574 |
| Salmeterol 50 mcg BD | Mean Use of Rescue Medication Over Period | Week 1 | 1.25 Puffs per 24 h | Standard Deviation 2.003 |
| Salmeterol 50 mcg BD | Mean Use of Rescue Medication Over Period | Run-in | 1.66 Puffs per 24 h | Standard Deviation 1.363 |
| Salmeterol 50 mcg BD | Mean Use of Rescue Medication Over Period | Week 2 | 0.93 Puffs per 24 h | Standard Deviation 0.962 |
Secondary
Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time
Blood samples were collected at pre-dose and 4 h post-dose on Day 1, Day 2, Day 7, Day 8, Day 14 and Day 15. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule.
Time frame: Day 1 up to Day 15
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 1 | 4.491 mmol/L | Standard Deviation 0.5698 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 2 | 5.913 mmol/L | Standard Deviation 1.4064 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 7 | 5.860 mmol/L | Standard Deviation 1.0459 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 8 | 5.679 mmol/L | Standard Deviation 1.4463 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 14 | 6.035 mmol/L | Standard Deviation 1.1987 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 15 | 5.927 mmol/L | Standard Deviation 1.3819 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 1 | 5.917 mmol/L | Standard Deviation 1.435 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 2 | 4.645 mmol/L | Standard Deviation 0.5498 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 7 | 4.494 mmol/L | Standard Deviation 0.8933 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 8 | 4.525 mmol/L | Standard Deviation 0.4862 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 14 | 4.458 mmol/L | Standard Deviation 0.5101 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 15 | 4.400 mmol/L | Standard Deviation 0.4552 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 1 | 6.62 mmol/L | Standard Deviation 2.434 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 2 | 6.29 mmol/L | Standard Deviation 1.735 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 7 | 6.49 mmol/L | Standard Deviation 1.539 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 8 | 6.16 mmol/L | Standard Deviation 1.99 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 14 | 6.30 mmol/L | Standard Deviation 1.477 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 15 | 6.28 mmol/L | Standard Deviation 1.636 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 1 | 4.18 mmol/L | Standard Deviation 0.427 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 2 | 4.35 mmol/L | Standard Deviation 0.346 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 7 | 4.28 mmol/L | Standard Deviation 0.835 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 8 | 4.34 mmol/L | Standard Deviation 0.468 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 14 | 4.20 mmol/L | Standard Deviation 0.388 |
| Placebo | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 15 | 4.24 mmol/L | Standard Deviation 0.43 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 15 | 4.29 mmol/L | Standard Deviation 0.366 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 1 | 5.54 mmol/L | Standard Deviation 0.801 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 8 | 5.266 mmol/L | Standard Deviation 0.9408 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 14 | 4.15 mmol/L | Standard Deviation 0.467 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 8 | 4.34 mmol/L | Standard Deviation 0.473 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 2 | 5.77 mmol/L | Standard Deviation 1.411 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 7 | 4.212 mmol/L | Standard Deviation 0.4412 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 14 | 5.67 mmol/L | Standard Deviation 0.976 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 15 | 5.196 mmol/L | Standard Deviation 0.8684 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 7 | 5.60 mmol/L | Standard Deviation 0.967 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 7 | 5.271 mmol/L | Standard Deviation 0.6604 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 8 | 5.64 mmol/L | Standard Deviation 0.993 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 7 | 3.91 mmol/L | Standard Deviation 0.501 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 8 | 4.549 mmol/L | Standard Deviation 0.495 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 2 | 4.24 mmol/L | Standard Deviation 0.412 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 2 | 5.237 mmol/L | Standard Deviation 1.0555 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 2 | 4.541 mmol/L | Standard Deviation 0.3952 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 14 | 4.298 mmol/L | Standard Deviation 0.5123 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 1 | 4.271 mmol/L | Standard Deviation 0.6109 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 1 | 4.05 mmol/L | Standard Deviation 0.584 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 1 | 5.202 mmol/L | Standard Deviation 0.6244 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 15 | 4.582 mmol/L | Standard Deviation 0.3869 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 14 | 5.406 mmol/L | Standard Deviation 0.4841 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 15 | 5.61 mmol/L | Standard Deviation 1.113 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 14 | 4.250 mmol/L | Standard Deviation 0.3694 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 1 | 4.174 mmol/L | Standard Deviation 0.3005 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 2 | 4.220 mmol/L | Standard Deviation 0.2719 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 7 | 4.154 mmol/L | Standard Deviation 0.3908 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 8 | 4.240 mmol/L | Standard Deviation 0.3727 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 7 | 3.89 mmol/L | Standard Deviation 0.355 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 2 | 4.03 mmol/L | Standard Deviation 0.291 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 15 | 4.241 mmol/L | Standard Deviation 0.4811 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 1 | 6.11 mmol/L | Standard Deviation 1.582 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 2 | 6.21 mmol/L | Standard Deviation 1.439 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 8 | 4.00 mmol/L | Standard Deviation 0.338 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 7 | 6.24 mmol/L | Standard Deviation 2.103 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 8 | 6.25 mmol/L | Standard Deviation 1.85 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 15 | 3.93 mmol/L | Standard Deviation 0.379 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 14 | 6.50 mmol/L | Standard Deviation 2.724 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 15 | 6.37 mmol/L | Standard Deviation 1.592 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 14 | 4.00 mmol/L | Standard Deviation 0.163 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 1 | 5.537 mmol/L | Standard Deviation 0.8241 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 2 | 5.763 mmol/L | Standard Deviation 1.1516 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 1 | 4.02 mmol/L | Standard Deviation 0.307 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 7 | 5.636 mmol/L | Standard Deviation 1.0571 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 8 | 5.839 mmol/L | Standard Deviation 1.5742 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 14 | 5.384 mmol/L | Standard Deviation 0.6367 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 15 | 5.599 mmol/L | Standard Deviation 1.1422 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 14 | 4.08 mmol/L | Standard Deviation 0.376 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 7 | 3.91 mmol/L | Standard Deviation 0.535 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 2 | 4.628 mmol/L | Standard Deviation 0.8501 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 1 | 5.744 mmol/L | Standard Deviation 1.0359 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 14 | 4.321 mmol/L | Standard Deviation 0.2958 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 8 | 4.503 mmol/L | Standard Deviation 0.3247 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 15 | 5.557 mmol/L | Standard Deviation 1.2105 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 2 | 5.626 mmol/L | Standard Deviation 1.3748 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 14 | 5.460 mmol/L | Standard Deviation 0.8837 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 7 | 4.258 mmol/L | Standard Deviation 0.4597 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 2 | 4.28 mmol/L | Standard Deviation 0.81 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 7 | 5.649 mmol/L | Standard Deviation 1.2134 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 8 | 4.28 mmol/L | Standard Deviation 0.328 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 7 | 6.28 mmol/L | Standard Deviation 1.56 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 1 | 3.94 mmol/L | Standard Deviation 0.341 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 8 | 6.14 mmol/L | Standard Deviation 1.914 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Minimum Potassium 0-4 h, Day 15 | 4.22 mmol/L | Standard Deviation 0.279 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 2 | 6.13 mmol/L | Standard Deviation 1.728 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 1 | 4.352 mmol/L | Standard Deviation 0.355 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 14 | 5.86 mmol/L | Standard Deviation 1.241 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 1 | 6.12 mmol/L | Standard Deviation 1.235 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Potassium 0-4 h, Day 15 | 4.466 mmol/L | Standard Deviation 0.2841 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Weighted Mean Glucose 0-4 h, Day 8 | 5.461 mmol/L | Standard Deviation 1.2427 |
| Salmeterol 50 mcg BD | Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time | Maximum Glucose 0-4 h, Day 15 | 6.19 mmol/L | Standard Deviation 1.664 |
Secondary
Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM
HR was measured using 28.5 h ABPM. Weighted mean HR at 0-4 h was obtained from measurements made over 0-4 h post-dose on Day 1, 2, 7, 8, 14 and 15. Weighted mean HR at 0-24 h was obtained from measurements made 0-24 h post-dose on Day 1, 7 and 14. Maximum HR at 0-4 h was obtained from measurements made over 0-4 h post-dose on Day 1, 2, 7, 8, 14 and 15. Baseline was defined as the pre-dose weighted mean of Day 1.
Time frame: Day 1 up to Day 15
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 1 | 70.08 bpm | Standard Deviation 10.722 |
| Placebo | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 7 | 97.9 bpm | Standard Deviation 13.76 |
| Placebo | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-24, Day 14 | 75.72 bpm | Standard Deviation 11.473 |
| Placebo | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 7 | 78.69 bpm | Standard Deviation 12.493 |
| Placebo | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 1 | 94.9 bpm | Standard Deviation 18.38 |
| Placebo | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 2 | 82.4 bpm | Standard Deviation 17.8 |
| Placebo | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 8 | 73.82 bpm | Standard Deviation 15.927 |
| Placebo | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 2 | 71.07 bpm | Standard Deviation 14.743 |
| Placebo | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 14 | 95.2 bpm | Standard Deviation 12.16 |
| Placebo | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 14 | 76.49 bpm | Standard Deviation 12.635 |
| Placebo | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 15 | 75.64 bpm | Standard Deviation 18.666 |
| Placebo | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 8 | 82.2 bpm | Standard Deviation 19.23 |
| Placebo | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-24, Day 1 | 70.07 bpm | Standard Deviation 10.079 |
| Placebo | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 15 | 84.8 bpm | Standard Deviation 19.24 |
| Placebo | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-24, Day 7 | 75.83 bpm | Standard Deviation 11.085 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-24, Day 7 | 72.35 bpm | Standard Deviation 11.046 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 7 | 90.5 bpm | Standard Deviation 18.85 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 14 | 71.14 bpm | Standard Deviation 11.771 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-24, Day 14 | 70.45 bpm | Standard Deviation 10.977 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 2 | 68.24 bpm | Standard Deviation 10.081 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 2 | 79.4 bpm | Standard Deviation 15.9 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 8 | 80.6 bpm | Standard Deviation 18.06 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 1 | 90.3 bpm | Standard Deviation 17.72 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 7 | 73.01 bpm | Standard Deviation 12.943 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-24, Day 1 | 72.33 bpm | Standard Deviation 11.592 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 15 | 78.7 bpm | Standard Deviation 16.37 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 14 | 87.0 bpm | Standard Deviation 14.68 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 15 | 68.82 bpm | Standard Deviation 12.98 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 8 | 70.17 bpm | Standard Deviation 11.353 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 1 | 72.23 bpm | Standard Deviation 12.766 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-24, Day 7 | 74.05 bpm | Standard Deviation 11.298 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 1 | 73.03 bpm | Standard Deviation 13.251 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 2 | 70.47 bpm | Standard Deviation 11.771 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 7 | 73.63 bpm | Standard Deviation 10.354 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 8 | 73.20 bpm | Standard Deviation 13.379 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 14 | 73.74 bpm | Standard Deviation 11.469 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 15 | 73.00 bpm | Standard Deviation 11.033 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-24, Day 1 | 71.83 bpm | Standard Deviation 11.772 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-24, Day 14 | 72.42 bpm | Standard Deviation 10.097 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 1 | 88.6 bpm | Standard Deviation 13.91 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 2 | 79.5 bpm | Standard Deviation 16.07 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 7 | 88.7 bpm | Standard Deviation 17.07 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 8 | 82.0 bpm | Standard Deviation 16.14 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 14 | 92.9 bpm | Standard Deviation 20.08 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 15 | 82.6 bpm | Standard Deviation 10.95 |
| Salmeterol 50 mcg BD | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-24, Day 1 | 78.53 bpm | Standard Deviation 8.525 |
| Salmeterol 50 mcg BD | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 2 | 77.12 bpm | Standard Deviation 11.461 |
| Salmeterol 50 mcg BD | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 7 | 94.6 bpm | Standard Deviation 14.86 |
| Salmeterol 50 mcg BD | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 15 | 77.60 bpm | Standard Deviation 10.298 |
| Salmeterol 50 mcg BD | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 14 | 80.39 bpm | Standard Deviation 10.801 |
| Salmeterol 50 mcg BD | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 1 | 77.50 bpm | Standard Deviation 10.092 |
| Salmeterol 50 mcg BD | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 8 | 86.9 bpm | Standard Deviation 14.31 |
| Salmeterol 50 mcg BD | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 8 | 77.76 bpm | Standard Deviation 13.003 |
| Salmeterol 50 mcg BD | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-4, Day 7 | 78.44 bpm | Standard Deviation 13.191 |
| Salmeterol 50 mcg BD | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 15 | 88.7 bpm | Standard Deviation 13.9 |
| Salmeterol 50 mcg BD | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 1 | 92.7 bpm | Standard Deviation 13.9 |
| Salmeterol 50 mcg BD | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-24, Day 14 | 78.93 bpm | Standard Deviation 8.054 |
| Salmeterol 50 mcg BD | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 14 | 96.2 bpm | Standard Deviation 12.21 |
| Salmeterol 50 mcg BD | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Maximum HR 0-4 h, Day 2 | 86.3 bpm | Standard Deviation 14.03 |
| Salmeterol 50 mcg BD | Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM | Weighted mean HR 0-24, Day 7 | 78.18 bpm | Standard Deviation 9.649 |
Secondary
Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM
BP was measured using 28.5 h ABPM. Weighted mean SBP and DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. Weighted mean SBP and DBP at 0-24 h post-dose was obtained on Day 1, 7 and 14. Maximum SBP and minimum DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. Baseline was defined as the pre-dose weighted mean of Day 1.
Time frame: Day 1 up to Day 15
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 2 | 80.81 mmHg | Standard Deviation 9.182 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 1 | 82.48 mmHg | Standard Deviation 9.817 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-24, Day 14 | 125.45 mmHg | Standard Deviation 16.546 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 14 | 65.8 mmHg | Standard Deviation 14.53 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 15 | 142.8 mmHg | Standard Deviation 21.83 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 14 | 148.4 mmHg | Standard Deviation 20.04 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 1 | 150.0 mmHg | Standard Deviation 18.72 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 2 | 73.6 mmHg | Standard Deviation 11.43 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 8 | 141.1 mmHg | Standard Deviation 17.13 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 7 | 143.9 mmHg | Standard Deviation 20.1 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 2 | 140.0 mmHg | Standard Deviation 19.98 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 1 | 73.1 mmHg | Standard Deviation 9.14 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 8 | 128.54 mmHg | Standard Deviation 16.817 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 2 | 128.15 mmHg | Standard Deviation 18.616 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-24, Day 14 | 76.07 mmHg | Standard Deviation 9.443 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 1 | 130.55 mmHg | Standard Deviation 15.052 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 14 | 130.71 mmHg | Standard Deviation 17.527 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 15 | 70.6 mmHg | Standard Deviation 9.17 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-24, Day 7 | 76.20 mmHg | Standard Deviation 9.831 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-24, Day 1 | 74.44 mmHg | Standard Deviation 8.758 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 15 | 128.84 mmHg | Standard Deviation 17.647 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 8 | 74.1 mmHg | Standard Deviation 10.49 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 15 | 79.25 mmHg | Standard Deviation 9.154 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 14 | 81.49 mmHg | Standard Deviation 10.037 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-24, Day 1 | 122.64 mmHg | Standard Deviation 16.675 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 7 | 72.6 mmHg | Standard Deviation 10.55 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 8 | 81.88 mmHg | Standard Deviation 11.151 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 7 | 82.83 mmHg | Standard Deviation 10.367 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-24, Day 7 | 124.22 mmHg | Standard Deviation 16.893 |
| Placebo | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 7 | 129.32 mmHg | Standard Deviation 16.655 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-24, Day 7 | 72.18 mmHg | Standard Deviation 6.598 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 1 | 128.47 mmHg | Standard Deviation 11.67 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 2 | 122.90 mmHg | Standard Deviation 13.129 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 7 | 126.46 mmHg | Standard Deviation 15.897 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 8 | 123.65 mmHg | Standard Deviation 15.12 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 14 | 124.59 mmHg | Standard Deviation 9.64 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 15 | 120.74 mmHg | Standard Deviation 14.472 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-24, Day 1 | 117.48 mmHg | Standard Deviation 11.246 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-24, Day 7 | 118.98 mmHg | Standard Deviation 11.587 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-24, Day 14 | 118.60 mmHg | Standard Deviation 8.748 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 1 | 146.4 mmHg | Standard Deviation 15.61 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 2 | 137.4 mmHg | Standard Deviation 15.78 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 7 | 142.7 mmHg | Standard Deviation 20.02 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 8 | 138.1 mmHg | Standard Deviation 19.26 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 14 | 143.3 mmHg | Standard Deviation 14.06 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 15 | 131.4 mmHg | Standard Deviation 16.91 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 1 | 77.54 mmHg | Standard Deviation 8.2 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 2 | 74.01 mmHg | Standard Deviation 7.959 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 7 | 78.07 mmHg | Standard Deviation 8.744 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 8 | 75.82 mmHg | Standard Deviation 9.09 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 14 | 76.31 mmHg | Standard Deviation 4.101 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 15 | 75.25 mmHg | Standard Deviation 7.33 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-24, Day 1 | 70.53 mmHg | Standard Deviation 7.941 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-24, Day 14 | 71.24 mmHg | Standard Deviation 5.775 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 1 | 66.4 mmHg | Standard Deviation 9.73 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 2 | 65.1 mmHg | Standard Deviation 9.74 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 7 | 63.3 mmHg | Standard Deviation 12.12 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 8 | 65.2 mmHg | Standard Deviation 11.95 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 14 | 62.8 mmHg | Standard Deviation 7.75 |
| GW642444 100 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 15 | 66.4 mmHg | Standard Deviation 8.6 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-24, Day 7 | 71.10 mmHg | Standard Deviation 10.471 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-24, Day 7 | 124.60 mmHg | Standard Deviation 12.774 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 8 | 127.55 mmHg | Standard Deviation 13.141 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 15 | 64.0 mmHg | Standard Deviation 15.06 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-24, Day 14 | 69.95 mmHg | Standard Deviation 11.156 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 8 | 65.1 mmHg | Standard Deviation 11.1 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 14 | 72.14 mmHg | Standard Deviation 10.218 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 14 | 59.3 mmHg | Standard Deviation 13.32 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 1 | 65.4 mmHg | Standard Deviation 12.03 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 2 | 129.23 mmHg | Standard Deviation 16.139 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 7 | 130.52 mmHg | Standard Deviation 13.432 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 15 | 124.68 mmHg | Standard Deviation 14.886 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 2 | 145.9 mmHg | Standard Deviation 21.48 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 7 | 74.87 mmHg | Standard Deviation 11.216 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 15 | 71.94 mmHg | Standard Deviation 11.908 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 2 | 63.4 mmHg | Standard Deviation 12.27 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 7 | 148.4 mmHg | Standard Deviation 18.6 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 1 | 77.46 mmHg | Standard Deviation 11.603 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 1 | 147.6 mmHg | Standard Deviation 18.78 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-24, Day 1 | 124.41 mmHg | Standard Deviation 13.961 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 8 | 141.8 mmHg | Standard Deviation 17.64 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 2 | 74.67 mmHg | Standard Deviation 12.607 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-24, Day 1 | 71.58 mmHg | Standard Deviation 10.67 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 8 | 74.77 mmHg | Standard Deviation 10.137 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 14 | 141.3 mmHg | Standard Deviation 14.43 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 14 | 124.86 mmHg | Standard Deviation 13.833 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-24, Day 14 | 122.71 mmHg | Standard Deviation 16.117 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 1 | 130.66 mmHg | Standard Deviation 16.508 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 15 | 138.4 mmHg | Standard Deviation 13.08 |
| GW642444 400 mcg Once Daily | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 7 | 63.9 mmHg | Standard Deviation 11.53 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 15 | 129.8 mmHg | Standard Deviation 15.02 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 1 | 78.14 mmHg | Standard Deviation 10.879 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 7 | 67.1 mmHg | Standard Deviation 8.07 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 2 | 77.07 mmHg | Standard Deviation 12.058 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-24, Day 1 | 117.94 mmHg | Standard Deviation 11.565 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 7 | 74.63 mmHg | Standard Deviation 8.888 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 15 | 65.6 mmHg | Standard Deviation 13.92 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 8 | 71.24 mmHg | Standard Deviation 10.305 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 15 | 118.52 mmHg | Standard Deviation 14.773 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 14 | 76.10 mmHg | Standard Deviation 8.595 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 8 | 62.6 mmHg | Standard Deviation 12.38 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-4, Day 15 | 73.61 mmHg | Standard Deviation 12.81 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 14 | 122.94 mmHg | Standard Deviation 11.67 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 1 | 126.05 mmHg | Standard Deviation 14.111 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-24, Day 1 | 70.49 mmHg | Standard Deviation 10.53 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 8 | 117.26 mmHg | Standard Deviation 11.281 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-24, Day 7 | 67.46 mmHg | Standard Deviation 7.075 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean DBP 0-24, Day 14 | 71.00 mmHg | Standard Deviation 7.793 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 7 | 123.10 mmHg | Standard Deviation 12.523 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 1 | 69.3 mmHg | Standard Deviation 9.99 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 14 | 67.4 mmHg | Standard Deviation 10.67 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 2 | 136.0 mmHg | Standard Deviation 16.71 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 1 | 141.3 mmHg | Standard Deviation 15.03 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 7 | 135.5 mmHg | Standard Deviation 15.97 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Minimum DBP 0-4 h, Day 2 | 68.1 mmHg | Standard Deviation 12.84 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 8 | 129.4 mmHg | Standard Deviation 14.06 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-24, Day 14 | 119.11 mmHg | Standard Deviation 9.109 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-4, Day 2 | 124.03 mmHg | Standard Deviation 16.147 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Maximum SBP 0-4 h, Day 14 | 135.1 mmHg | Standard Deviation 12.94 |
| Salmeterol 50 mcg BD | Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM | Weighted mean SBP 0-24, Day 7 | 116.34 mmHg | Standard Deviation 11.15 |
Secondary
Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time
A holter monitor is a machine that continuously records the heart's electrical activity. A 3-lead holter ECG monitoring device was used. The monitor was worn for 24 h during normal activity to record the heart's rhythm. The assessment for the events of supra ventricular ectopics, ventricular ectopics and ventricular runs per 24 h was done on Day 1, Day 7 and Day 14.
Time frame: Day 1 up to Day 14
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 1, Ventricular runs | 0.0 Number of events | Standard Deviation 0 |
| Placebo | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 14, Ventricular ectopics | 0.5 Number of events | Standard Deviation 1.87 |
| Placebo | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 7, Ventricular ectopics | 1.0 Number of events | Standard Deviation 4 |
| Placebo | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 7, Supra ventricular ectopics | 97.8 Number of events | Standard Deviation 220.23 |
| Placebo | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 14, Supra ventricular ectopics | 27.5 Number of events | Standard Deviation 42.17 |
| Placebo | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 1, Ventricular ectopics | 0.0 Number of events | Standard Deviation 0 |
| Placebo | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 1, Supra ventricular ectopics | 107.2 Number of events | Standard Deviation 259.78 |
| Placebo | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 7, Ventricular runs | 0.1 Number of events | Standard Deviation 0.25 |
| Placebo | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 14, Ventricular runs | 0.1 Number of events | Standard Deviation 0.27 |
| GW642444 100 mcg Once Daily | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 7, Ventricular ectopics | 0.2 Number of events | Standard Deviation 0.77 |
| GW642444 100 mcg Once Daily | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 1, Supra ventricular ectopics | 397.3 Number of events | Standard Deviation 982.72 |
| GW642444 100 mcg Once Daily | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 1, Ventricular ectopics | 0.8 Number of events | Standard Deviation 1.65 |
| GW642444 100 mcg Once Daily | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 1, Ventricular runs | 0.2 Number of events | Standard Deviation 0.4 |
| GW642444 100 mcg Once Daily | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 7, Supra ventricular ectopics | 321.4 Number of events | Standard Deviation 985.25 |
| GW642444 100 mcg Once Daily | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 7, Ventricular runs | 0.1 Number of events | Standard Deviation 0.26 |
| GW642444 100 mcg Once Daily | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 14, Supra ventricular ectopics | 398.1 Number of events | Standard Deviation 1005.29 |
| GW642444 100 mcg Once Daily | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 14, Ventricular ectopics | 0.4 Number of events | Standard Deviation 1.55 |
| GW642444 100 mcg Once Daily | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 14, Ventricular runs | 0.1 Number of events | Standard Deviation 0.52 |
| GW642444 400 mcg Once Daily | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 1, Ventricular runs | 1.0 Number of events | Standard Deviation 3.16 |
| GW642444 400 mcg Once Daily | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 7, Ventricular ectopics | 0.2 Number of events | Standard Deviation 0.8 |
| GW642444 400 mcg Once Daily | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 1, Ventricular ectopics | 3.6 Number of events | Standard Deviation 10.8 |
| GW642444 400 mcg Once Daily | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 7, Ventricular runs | 0.1 Number of events | Standard Deviation 0.27 |
| GW642444 400 mcg Once Daily | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 14, Supra ventricular ectopics | 333.5 Number of events | Standard Deviation 821.98 |
| GW642444 400 mcg Once Daily | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 1, Supra ventricular ectopics | 134.9 Number of events | Standard Deviation 249.35 |
| GW642444 400 mcg Once Daily | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 14, Ventricular runs | 0.0 Number of events | Standard Deviation 0 |
| GW642444 400 mcg Once Daily | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 14, Ventricular ectopics | 0.0 Number of events | Standard Deviation 0 |
| GW642444 400 mcg Once Daily | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 7, Supra ventricular ectopics | 442.5 Number of events | Standard Deviation 900.98 |
| Salmeterol 50 mcg BD | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 1, Ventricular runs | 0.1 Number of events | Standard Deviation 0.25 |
| Salmeterol 50 mcg BD | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 14, Supra ventricular ectopics | 93.3 Number of events | Standard Deviation 121.83 |
| Salmeterol 50 mcg BD | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 7, Ventricular ectopics | 0.0 Number of events | Standard Deviation 0 |
| Salmeterol 50 mcg BD | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 7, Supra ventricular ectopics | 73.0 Number of events | Standard Deviation 120.87 |
| Salmeterol 50 mcg BD | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 14, Ventricular ectopics | 0.0 Number of events | Standard Deviation 0 |
| Salmeterol 50 mcg BD | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 1, Ventricular ectopics | 0.3 Number of events | Standard Deviation 1 |
| Salmeterol 50 mcg BD | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 7, Ventricular runs | 0.0 Number of events | Standard Deviation 0 |
| Salmeterol 50 mcg BD | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 1, Supra ventricular ectopics | 61.9 Number of events | Standard Deviation 128.69 |
| Salmeterol 50 mcg BD | Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time | Day 14, Ventricular runs | 0.0 Number of events | Standard Deviation 0 |
Secondary
Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14
The parameters of biochemistry with their normal range included: alanine amino transferase (\[ALT\] 0-48 international units per liter \[IU/L\]), albumin (32-50 gram \[g\]/L), alkaline phosphatase (\[ALP\] 20-125 IU/L), aspartate amino transferase (\[AST\] 0-42 IU/L), calcium (2.12-2.56 millimole \[mmol\]/L, chloride (95-108 mmol/L), creatine kinase (\[CK\] 0-235 IU/L), creatinine (44-124 micromole \[µmol\]/L), direct bilirubin (0-6 µmol/L), gamma glutamyl transferase (\[GGT\] 0-65 IU/L), glucose (3.9-6.9 mmol/L), lactate dehydrogenase (\[LDH\] 0-250 IU/L), potassium (3.5-5.3 mmol/L), sodium (135-146 mmol/L), total bilirubin (0-22 µmol/L), total protein (60-85 g/L), urea (2.5-9 mmol/L) and uric acid (250-510 µmol/L). The assessments were performed on Day 1, Day 7 and Day 14. Baseline was defined as the assessment done on Day 1. Only those parameters for which at least one value of abnormality (to low or to high) change from Baseline, relative to normal ranges were reported are summarized.
Time frame: Baseline (Day 1) up to Day 14
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | ALT, change to high, Day 7 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | CK, change to high, Day 14 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Sodium, change to low, Day 7 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | AST, change to high, Day 14 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | LDH, change to high, Day 7 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Direct Bilirubin, change to high, Day 7 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Chloride, change to low, Day 7 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Uric acid, change to low, Day 14 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Urea, change to high, Day 7 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | GGT, change to high, Day 7 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Sodium, change to high, Day 7 | 1 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Potassium, change to high, Day 14 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Chloride, change to high, Day 7 | 1 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | GGT, change to high, Day 14 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Bilirubin, change to high, Day 7 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | LDH, change to high, Day 14 | 1 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Protein, change to low, Day 14 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Glucose, change to high, Day 7 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Urea, change to low, Day 14 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Calcium, change to low, Day 14 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Chloride, change to high, Day 14 | 1 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Glucose, change to low, Day 14 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Sodium, change to high, Day 14 | 1 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Uric acid, change to high, Day 14 | 0 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Protein, change to low, Day 7 | 1 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Glucose, change to high, Day 14 | 1 Participants |
| Placebo | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | AST, change to high, Day 7 | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Glucose, change to high, Day 14 | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Bilirubin, change to high, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | LDH, change to high, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | LDH, change to high, Day 14 | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Sodium, change to high, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Potassium, change to high, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Chloride, change to low, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Sodium, change to low, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | AST, change to high, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Sodium, change to high, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Urea, change to low, Day 14 | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Chloride, change to high, Day 7 | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | ALT, change to high, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Chloride, change to high, Day 14 | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | CK, change to high, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Urea, change to high, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Direct Bilirubin, change to high, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | AST, change to high, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | GGT, change to high, Day 7 | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Uric acid, change to high, Day 14 | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Protein, change to low, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | GGT, change to high, Day 14 | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Uric acid, change to low, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Glucose, change to high, Day 7 | 2 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Protein, change to low, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Glucose, change to low, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Calcium, change to low, Day 14 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Urea, change to high, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | ALT, change to high, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | AST, change to high, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | AST, change to high, Day 14 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Calcium, change to low, Day 14 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Chloride, change to low, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Chloride, change to high, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Chloride, change to high, Day 14 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | CK, change to high, Day 14 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Direct Bilirubin, change to high, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | GGT, change to high, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | GGT, change to high, Day 14 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Glucose, change to high, Day 7 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Glucose, change to low, Day 14 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Glucose, change to high, Day 14 | 2 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | LDH, change to high, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | LDH, change to high, Day 14 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Potassium, change to high, Day 14 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Sodium, change to low, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Sodium, change to high, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Sodium, change to high, Day 14 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Bilirubin, change to high, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Protein, change to low, Day 7 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Protein, change to low, Day 14 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Urea, change to low, Day 14 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Uric acid, change to low, Day 14 | 3 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Uric acid, change to high, Day 14 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Glucose, change to high, Day 14 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Uric acid, change to high, Day 14 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Bilirubin, change to high, Day 7 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Glucose, change to low, Day 14 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Glucose, change to high, Day 7 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Uric acid, change to low, Day 14 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Protein, change to low, Day 7 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | GGT, change to high, Day 14 | 2 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | GGT, change to high, Day 7 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | AST, change to high, Day 7 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Protein, change to low, Day 14 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Direct Bilirubin, change to high, Day 7 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | CK, change to high, Day 14 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Chloride, change to high, Day 14 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Urea, change to high, Day 7 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Chloride, change to high, Day 7 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Chloride, change to low, Day 7 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | ALT, change to high, Day 7 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Urea, change to low, Day 14 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Sodium, change to low, Day 7 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Calcium, change to low, Day 14 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Sodium, change to high, Day 7 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Potassium, change to high, Day 14 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | LDH, change to high, Day 14 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | AST, change to high, Day 14 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Sodium, change to high, Day 14 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | LDH, change to high, Day 7 | 1 Participants |
Secondary
Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14
The parameters of biochemistry with their normal range included: basophils (0-0.2 giga cells \[GI\]/L), eosinophils (0.05-0.55 GI/L), haematocrit (0.41-0.5 ratio), hemoglobin (138-172 g/L), lymphocytes (0.85-4.1 GI/L), mean corpuscle hemoglobin (\[MCH\] 27-33 picogram \[pg\]), mean corpuscle hemoglobin concentration (\[MCHC\] 320-360 g/L), mean corpuscle volume (\[MCV\] 80-100 femtoliter \[fl\]), monocytes (0.2-1.1 GI/L), segmented neutrophils (1.8-8 GI/L), total neutrophils (1.8-8 GI/L), platelet count (130-400 GI/L), red blood cell (\[RBC\] 4.4-5.8 trillion cells \[TI\]/L) count and white blood cell (\[WBC\] 3.8-10.8 GI/L) count. The assessments were performed on Day 1, Day 7 and Day 14. Baseline was defined as the assessment done on Day 1. Only those parameters for which at least one value of abnormality (to low or to high) change from Baseline, relative to normal ranges were reported are summarized.
Time frame: Baseline (Day 1) up to Day 14
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Monocytes, change to low, Day 14 | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Monocytes, change to high, Day 7 | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Lymphocytes, change to high, Day 7 | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | WBC count, change to low, Day 14 | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Monocytes, change to low, Day 7 | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | MCV, change to high, Day 14 | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Lymphocytes, change to low, Day 14 | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Neutrophils, change to high, Day 14 | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | MCV, change to high, Day 7 | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | MCH, change to high, Day 14 | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | MCH, change to high, Day 7 | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Neutrophils, change to low, Day 14 | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hematocrit, change to low, Day 7 | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Eosinophils, change to high, Day 7 | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Neutrophils, change to high, Day 7 | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Neutrophils, change to low, Day 7 | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hematocrit, change to high, Day 7 | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Eosinophils, change to low, Day 7 | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Segmented Neutrophils, change to high, Day 14 | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Segmented Neutrophils, change to low, Day 14 | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hematocrit, change to low, Day 14 | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | WBC count, change to high, Day 14 | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Segmented Neutrophils, change to high, Day 7 | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Segmented Neutrophils, change to low, Day 7 | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hemoglobin, change to low, Day 7 | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | WBC count, change to high, Day 7 | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | RBC count, change to low, Day 14 | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | RBC count, change to low, Day 7 | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hemoglobin, change to low, Day 14 | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | WBC count, change to low, Day 7 | 2 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Platelet count, change to high, Day 14 | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Monocytes, change to high, Day 14 | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Lymphocytes, change to low, Day 7 | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Eosinophils, change to high, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hematocrit, change to high, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Eosinophils, change to low, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Eosinophils, change to high, Day 7 | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Eosinophils, change to high, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hematocrit, change to low, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hematocrit, change to low, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hemoglobin, change to low, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hemoglobin, change to low, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Lymphocytes, change to low, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Lymphocytes, change to high, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Lymphocytes, change to low, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | MCH, change to high, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | MCH, change to high, Day 14 | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | MCV, change to high, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | MCV, change to high, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Monocytes, change to low, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Monocytes, change to high, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Monocytes, change to low, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Monocytes, change to high, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Platelet count, change to high, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | RBC count, change to low, Day 7 | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | RBC count, change to low, Day 14 | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Segmented Neutrophils, change to low, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Segmented Neutrophils, change to high, Day 7 | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Segmented Neutrophils, change to low, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Segmented Neutrophils, change to high, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Neutrophils, change to low, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Neutrophils, change to high, Day 7 | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Neutrophils, change to low, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Neutrophils, change to high, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | WBC count, change to low, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | WBC count, change to high, Day 7 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | WBC count, change to low, Day 14 | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | WBC count, change to high, Day 14 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hemoglobin, change to low, Day 7 | 2 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Monocytes, change to low, Day 14 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Monocytes, change to high, Day 14 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hemoglobin, change to low, Day 14 | 2 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Eosinophils, change to low, Day 7 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Platelet count, change to high, Day 14 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | WBC count, change to low, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | RBC count, change to low, Day 7 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Lymphocytes, change to low, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | RBC count, change to low, Day 14 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Eosinophils, change to high, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Segmented Neutrophils, change to low, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hematocrit, change to low, Day 14 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Segmented Neutrophils, change to high, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | WBC count, change to high, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Segmented Neutrophils, change to low, Day 14 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hematocrit, change to high, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Segmented Neutrophils, change to high, Day 14 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Neutrophils, change to low, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hematocrit, change to low, Day 7 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | WBC count, change to high, Day 14 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Neutrophils, change to high, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | WBC count, change to low, Day 14 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | MCH, change to high, Day 7 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Neutrophils, change to low, Day 14 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | MCH, change to high, Day 14 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Lymphocytes, change to low, Day 14 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | MCV, change to high, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Eosinophils, change to high, Day 14 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | MCV, change to high, Day 14 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Lymphocytes, change to high, Day 7 | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Monocytes, change to low, Day 7 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Neutrophils, change to high, Day 14 | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Monocytes, change to high, Day 7 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | MCH, change to high, Day 14 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Neutrophils, change to high, Day 14 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Segmented Neutrophils, change to high, Day 14 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Monocytes, change to low, Day 14 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hemoglobin, change to low, Day 14 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Eosinophils, change to high, Day 7 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hematocrit, change to low, Day 7 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Monocytes, change to high, Day 14 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Eosinophils, change to low, Day 7 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Lymphocytes, change to low, Day 7 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Neutrophils, change to low, Day 7 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Platelet count, change to high, Day 14 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hemoglobin, change to low, Day 7 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Neutrophils, change to low, Day 14 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | WBC count, change to low, Day 14 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | RBC count, change to low, Day 7 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | MCV, change to high, Day 7 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | WBC count, change to low, Day 7 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Total Neutrophils, change to high, Day 7 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | RBC count, change to low, Day 14 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hematocrit, change to low, Day 14 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Eosinophils, change to high, Day 14 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Lymphocytes, change to high, Day 7 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Segmented Neutrophils, change to low, Day 7 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Monocytes, change to high, Day 7 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | WBC count, change to high, Day 14 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | MCH, change to high, Day 7 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Segmented Neutrophils, change to high, Day 7 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Hematocrit, change to high, Day 7 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Lymphocytes, change to low, Day 14 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Monocytes, change to low, Day 7 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | Segmented Neutrophils, change to low, Day 14 | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | MCV, change to high, Day 14 | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14 | WBC count, change to high, Day 7 | 1 Participants |
Secondary
Number of Participants With Rescue Free Days
Ipratropium bromide was provided as the rescue medication. The use of rescue medication was recorded by the participants on daily record cards each day in the morning and evening from Screening up to Follow-up. The percentage of rescue free days during the Run-in week, Week 1, Week 2 and Follow-up Week were assessed. Data is reported for number of participants with \< 20%, \>=20 to \<40%, \>=40 to \<60%, \>=60 to \<80% and \>=80% rescue free days.
Time frame: Up to Follow-up (Day 17)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants With Rescue Free Days | Week 2 | < 20% | 7 Participants |
| Placebo | Number of Participants With Rescue Free Days | Week 1 | < 20% | 7 Participants |
| Placebo | Number of Participants With Rescue Free Days | Run-in | >=20 to <40% | 0 Participants |
| Placebo | Number of Participants With Rescue Free Days | Run-in | < 20% | 10 Participants |
| Placebo | Number of Participants With Rescue Free Days | Week 1 | >=80% | 6 Participants |
| Placebo | Number of Participants With Rescue Free Days | Week 1 | >=60 to <80% | 0 Participants |
| Placebo | Number of Participants With Rescue Free Days | Follow-up | >=40 to <60% | 0 Participants |
| Placebo | Number of Participants With Rescue Free Days | Week 1 | >=40 to <60% | 2 Participants |
| Placebo | Number of Participants With Rescue Free Days | Follow-up | >=20 to <40% | 0 Participants |
| Placebo | Number of Participants With Rescue Free Days | Run-in | >=40 to <60% | 3 Participants |
| Placebo | Number of Participants With Rescue Free Days | Week 1 | >=20 to <40% | 1 Participants |
| Placebo | Number of Participants With Rescue Free Days | Follow-up | < 20% | 9 Participants |
| Placebo | Number of Participants With Rescue Free Days | Week 2 | >=80% | 6 Participants |
| Placebo | Number of Participants With Rescue Free Days | Run-in | >=60 to <80% | 1 Participants |
| Placebo | Number of Participants With Rescue Free Days | Follow-up | >=80% | 3 Participants |
| Placebo | Number of Participants With Rescue Free Days | Week 2 | >=60 to <80% | 1 Participants |
| Placebo | Number of Participants With Rescue Free Days | Week 2 | >=40 to <60% | 1 Participants |
| Placebo | Number of Participants With Rescue Free Days | Run-in | >=80% | 1 Participants |
| Placebo | Number of Participants With Rescue Free Days | Follow-up | >=60 to <80% | 0 Participants |
| Placebo | Number of Participants With Rescue Free Days | Week 2 | >=20 to <40% | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Run-in | >=40 to <60% | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Run-in | < 20% | 9 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Run-in | >=20 to <40% | 2 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Run-in | >=60 to <80% | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Run-in | >=80% | 3 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Week 1 | < 20% | 5 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Week 2 | >=60 to <80% | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Week 1 | >=20 to <40% | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Week 1 | >=40 to <60% | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Week 1 | >=60 to <80% | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Week 1 | >=80% | 5 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Week 2 | < 20% | 4 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Week 2 | >=20 to <40% | 1 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Week 2 | >=40 to <60% | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Week 2 | >=80% | 5 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Follow-up | < 20% | 8 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Follow-up | >=20 to <40% | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Follow-up | >=40 to <60% | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Follow-up | >=60 to <80% | 0 Participants |
| GW642444 100 mcg Once Daily | Number of Participants With Rescue Free Days | Follow-up | >=80% | 5 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Follow-up | >=40 to <60% | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Week 2 | < 20% | 3 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Run-in | >=80% | 4 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Week 2 | >=20 to <40% | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Follow-up | >=80% | 4 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Week 2 | >=40 to <60% | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Run-in | >=60 to <80% | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Follow-up | >=60 to <80% | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Week 2 | >=80% | 5 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Run-in | >=40 to <60% | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Follow-up | < 20% | 5 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Run-in | < 20% | 5 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Follow-up | >=20 to <40% | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Week 1 | >=20 to <40% | 0 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Week 2 | >=60 to <80% | 2 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Run-in | >=20 to <40% | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Week 1 | >=40 to <60% | 3 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Week 1 | >=60 to <80% | 1 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Week 1 | < 20% | 3 Participants |
| GW642444 400 mcg Once Daily | Number of Participants With Rescue Free Days | Week 1 | >=80% | 6 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Week 1 | >=20 to <40% | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Week 1 | >=80% | 6 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Run-in | >=80% | 3 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Follow-up | >=40 to <60% | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Follow-up | >=60 to <80% | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Week 2 | < 20% | 3 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Week 1 | < 20% | 4 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Run-in | < 20% | 10 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Follow-up | < 20% | 2 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Week 2 | >=20 to <40% | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Run-in | >=60 to <80% | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Run-in | >=20 to <40% | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Follow-up | >=80% | 5 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Week 2 | >=40 to <60% | 2 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Week 1 | >=60 to <80% | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Week 2 | >=60 to <80% | 2 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Run-in | >=40 to <60% | 2 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Follow-up | >=20 to <40% | 0 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Week 1 | >=40 to <60% | 1 Participants |
| Salmeterol 50 mcg BD | Number of Participants With Rescue Free Days | Week 2 | >=80% | 3 Participants |
Secondary
Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14
Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The time at which Cmax was observed and tlast was determined directly from the raw concentration-time data.
Time frame: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Population: PK Concentration Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14 | Tmax, Day 1 | 1.000 h |
| Placebo | Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14 | Tmax, Day 7 | 1.000 h |
| Placebo | Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14 | Tmax, Day 14 | 0.555 h |
| Placebo | Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14 | Tlast, Day 1 | 2.000 h |
| Placebo | Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14 | Tlast, Day 7 | 2.000 h |
| Placebo | Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14 | Tlast, Day 14 | 4.000 h |
| GW642444 100 mcg Once Daily | Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14 | Tlast, Day 7 | 4.000 h |
| GW642444 100 mcg Once Daily | Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14 | Tmax, Day 1 | 1.000 h |
| GW642444 100 mcg Once Daily | Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14 | Tlast, Day 1 | 4.000 h |
| GW642444 100 mcg Once Daily | Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14 | Tmax, Day 7 | 0.130 h |
| GW642444 100 mcg Once Daily | Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14 | Tlast, Day 14 | 4.000 h |
| GW642444 100 mcg Once Daily | Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14 | Tmax, Day 14 | 0.525 h |
Secondary
Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14
GW630200 and GSK932009 are metabolites of GW642444H. CCI2189 is a counterion of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The time at which Cmax was observed was determined directly from the raw concentration-time data.
Time frame: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Population: PK Concentration Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14 | CC12189, Day 1 | 1.285 h |
| Placebo | Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14 | CC12189, Day 7 | 1.010 h |
| Placebo | Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14 | CC12189, Day 14 | 1.000 h |
| Placebo | Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14 | GW630200, Day 1 | NA h |
| Placebo | Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14 | GW630200, Day 7 | NA h |
| Placebo | Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14 | GW630200, Day 14 | NA h |
| Placebo | Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14 | GSK932009, Day 7 | 2.500 h |
| Placebo | Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14 | GSK932009, Day 14 | 1.500 h |
| GW642444 100 mcg Once Daily | Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14 | GSK932009, Day 14 | 2.000 h |
| GW642444 100 mcg Once Daily | Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14 | GW630200, Day 7 | NA h |
| GW642444 100 mcg Once Daily | Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14 | CC12189, Day 1 | 1.000 h |
| GW642444 100 mcg Once Daily | Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14 | GSK932009, Day 7 | 2.000 h |
| GW642444 100 mcg Once Daily | Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14 | CC12189, Day 7 | 1.000 h |
| GW642444 100 mcg Once Daily | Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14 | GW630200, Day 14 | NA h |
| GW642444 100 mcg Once Daily | Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14 | CC12189, Day 14 | 1.000 h |
| GW642444 100 mcg Once Daily | Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14 | GSK932009, Day 1 | 2.050 h |
| GW642444 100 mcg Once Daily | Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14 | GW630200, Day 1 | NA h |
Secondary
Tmax of Salmeterol at Day 1, 7 and 14
Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The time at which Cmax was observed was determined directly from the raw concentration-time data.
Time frame: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Population: PK Concentration Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Tmax of Salmeterol at Day 1, 7 and 14 | Day 1 | 1.000 h |
| Placebo | Tmax of Salmeterol at Day 1, 7 and 14 | Day 7 | 1.000 h |
| Placebo | Tmax of Salmeterol at Day 1, 7 and 14 | Day 14 | 1.000 h |