Asthma
Conditions
Keywords
asthma, Fluticasone furoate, GW642444
Brief summary
The primary purpose of the study is to assess the safety and tolerability of 52-week teatment with fluticasone furoate/GW642444 inhalation powder once-daily and FF inhalation powder once-daily in Japanese adult subjects with asthma.
Interventions
Fluticasone Furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
Fluticasone Furoate inhalation powder inhaled orally once daily for 52 weeks
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Out patient at least 18 years of age * Both genderds; females of childbearing potential must be willing to use birth control method * A diagnosis of asthma at least 6 months prior to Screening * A best FEV1 of at least 50% of the predicted nomal value at Screening * Subjects have been receiving maintanance therapy for asthma, for at least 4 weeks prior to Screening
Exclusion criteria
* History of life-threating asthma * Respiratory infection or oral candidiasis * Asthma exacerbation within 12 weeks * Concurrent respiratory disease or other disease that would confound study participation or affect subject safety * Allergies to study drugs, study drugs7 excipients, medications related to study drugs * Taking another investigational medication or medication prohibited for use during this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) | From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD]) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a 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, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold \>=5%) and SAE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. |
| Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD | Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. |
| Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. |
| Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. |
| Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. |
| Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (BL) (Week -2), Week 12, Week 24 and Week 52/WD. |
| Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. |
| Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. |
| Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. |
| Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. |
| Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. |
| Change From Baseline in the 24-hour Urinary Cortisol Excretion | Baseline (Week 0), Week 24, and Week 52/WD | Urine samples were collected for measurement of urinary cortisol excretion at the following scheduled time points: Baseline (Week 0), Week 24, and Week 52/WD. The 24-hour urinary cortisol excretion was calculated by multiplying the total volume of urine by the concentration of urinary cortisol. Cortisol is a hormone released from the adrenal gland that helps in fat, protein, and carbohydrate metabolism. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Blood Pressure | Baseline (Week 0), Week 12, Week 24, and Week 52/WD | Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline (Week 0), Weeks 12, 24 and Week 52/WD. Blood pressure was measured in a sitting position after a participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in Heart Rate (HR) | Baseline (Week 0), Week 12, Week 24, and Week 52/WD | Heart rate was measured in a sitting position after a participant was kept at rest for at least 5 minutes at Baseline (Week 0), Weeks 12, 24 and Week 52/WD. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 12, Week 24, and Week 52/WD | A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes at assessment time points (Baseline\[Week -2\], Week 12, 24 and Week 52/WD) in the treatment period. Data are presented for clinically significant (CS) as well as not clinically significant (NCS) abnormal (Abn) findings. Any abnormal ECG, including those that worsen from Baseline, and determined clinically significant by the assessment of the investigator were recorded as CS. |
| Number of Participants With Severe Asthma Exacerbation During the Study Treatment | Baseline up to Week 52 | A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Courses of corticosteroids separated by 1 week or more were treated as separate severe exacerbations. |
| Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment | Baseline up to Week 52 | Change from Baseline in AM and PM PEF at 52 weeks of evaluation period during study treatment was recorded in the dairy record card. The Baseline value was calculated as the mean of all available data recorded during the7 days immediately prior to the treatment start date (including Day 1: Day 1 is treatment start date). The PEF is defined as the greatest rate of airflow that can be achieved during forced exhalation beginning with the lungs fully inflated. |
| Change From Baseline in Asthma Symptom Score During the Study Treatment | Baseline up to Week 52 | The Baseline value was calculated as the mean of all available data recorded during the 7 days immediately prior to Visit 2 (treatment assignment visit). Participants entered their asthma symptom score in the patient diary twice daily (morning and evening). Daytime asthma symptom scores: 0-no asthma symptoms, 1-one episode of short-time asthma symptoms, 2-two or more episodes of short-time asthma symptoms, 3-asthma symptoms occurring during most part of daytime without interference with daily life activities, 4-asthma symptoms occurring during most part of daytime with interference with daily life activities, 5-severe asthma symptoms that disable working or daily life activities. Nighttime asthma symptom scores: 0-no asthma symptoms, 1-one awakening due to asthma symptoms, 2-two or more awakenings due to asthma symptoms, 3-asthma symptoms almost prevented the participant from sleeping, 4-severe asthma symptoms completely prevented from sleeping. |
| Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the Study Treatment | Baseline up to Week 52 | Participants who were symptom free for 24-hours were assessed. Change from Baseline is calculated as the value at Week 52 minus the value at Baseline. |
| Change From Baseline in the Percentage of Rescue-free 24-hour Periods | Baseline up to Week 52 | The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered as a rescue free period. Change from Baseline is calculated as the value at Week 52 minus the value at Baseline. |
| Number of Rescue Medication Inhalations | Baseline up to Week 52 | Salbutamol inhaler was used as the rescue medication. Participants entered the number of rescue medication inhalations in the patient diary twice daily (morning and evening). |
| Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results can be read as negative (Neg), Trace (TRA), 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, trace, 1+, 2+, and 3+ levels at Baseline (Week -2) and Week 52/WD. |
Countries
Japan
Participant flow
Pre-assignment details
Following screening (Visit1) and a 2-week Run-in Period during which participants continued to use their respective asthma therapy at a fixed dose. Participants who met continuation criteria at the end of Run-in Period (Visit 2) were allocated to a 52-Week Treatment Period.
Participants by arm
| Arm | Count |
|---|---|
| FF/GW642444 100/25 µg Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period. | 60 |
| FF/GW642444 200/25 µg Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period. | 93 |
| FF 100 µg Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period. | 90 |
| Total | 243 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 11 | 2 |
| Overall Study | Protocol Defined Stopping Criteria | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 2 |
Baseline characteristics
| Characteristic | FF/GW642444 200/25 µg | FF 100 µg | Total | FF/GW642444 100/25 µg |
|---|---|---|---|---|
| Age, Continuous | 52.6 Years STANDARD_DEVIATION 15.05 | 46.8 Years STANDARD_DEVIATION 15.46 | 50.1 Years STANDARD_DEVIATION 15.06 | 51.3 Years STANDARD_DEVIATION 13.74 |
| Gender Female | 49 Participants | 54 Participants | 141 Participants | 38 Participants |
| Gender Male | 44 Participants | 36 Participants | 102 Participants | 22 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 93 Participants | 90 Participants | 243 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 52 / 60 | 77 / 93 | 72 / 90 |
| serious Total, serious adverse events | 4 / 60 | 7 / 93 | 1 / 90 |
Outcome results
Primary
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a 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, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold \>=5%) and SAE.
Time frame: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Population: Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of randomized medication in the treatment period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF/GW642444 100/25 µg | Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) | Any SAE | 4 Participants |
| FF/GW642444 100/25 µg | Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) | Any Non-serious AE | 52 Participants |
| FF/GW642444 200/25 µg | Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) | Any SAE | 7 Participants |
| FF/GW642444 200/25 µg | Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) | Any Non-serious AE | 77 Participants |
| FF 100 µg | Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) | Any SAE | 1 Participants |
| FF 100 µg | Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) | Any Non-serious AE | 72 Participants |
Secondary
Change From Baseline in Asthma Symptom Score During the Study Treatment
The Baseline value was calculated as the mean of all available data recorded during the 7 days immediately prior to Visit 2 (treatment assignment visit). Participants entered their asthma symptom score in the patient diary twice daily (morning and evening). Daytime asthma symptom scores: 0-no asthma symptoms, 1-one episode of short-time asthma symptoms, 2-two or more episodes of short-time asthma symptoms, 3-asthma symptoms occurring during most part of daytime without interference with daily life activities, 4-asthma symptoms occurring during most part of daytime with interference with daily life activities, 5-severe asthma symptoms that disable working or daily life activities. Nighttime asthma symptom scores: 0-no asthma symptoms, 1-one awakening due to asthma symptoms, 2-two or more awakenings due to asthma symptoms, 3-asthma symptoms almost prevented the participant from sleeping, 4-severe asthma symptoms completely prevented from sleeping.
Time frame: Baseline up to Week 52
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FF/GW642444 100/25 µg | Change From Baseline in Asthma Symptom Score During the Study Treatment | -0.14 Scores on a scale | Standard Deviation 0.638 |
| FF/GW642444 200/25 µg | Change From Baseline in Asthma Symptom Score During the Study Treatment | -0.14 Scores on a scale | Standard Deviation 0.856 |
| FF 100 µg | Change From Baseline in Asthma Symptom Score During the Study Treatment | -0.19 Scores on a scale | Standard Deviation 0.771 |
Secondary
Change From Baseline in Blood Pressure
Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline (Week 0), Weeks 12, 24 and Week 52/WD. Blood pressure was measured in a sitting position after a participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline (Week 0), Week 12, Week 24, and Week 52/WD
Population: ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/GW642444 100/25 µg | Change From Baseline in Blood Pressure | SBP, Week 12, n=58, 90, 88 | -1.6 Millimeters of Mercury (mmHg) | Standard Deviation 9.54 |
| FF/GW642444 100/25 µg | Change From Baseline in Blood Pressure | SBP, Week 24, n=58, 83, 86 | -0.7 Millimeters of Mercury (mmHg) | Standard Deviation 11.76 |
| FF/GW642444 100/25 µg | Change From Baseline in Blood Pressure | SBP Week 52/WD, n=60, 92, 89 | -1.5 Millimeters of Mercury (mmHg) | Standard Deviation 9.34 |
| FF/GW642444 100/25 µg | Change From Baseline in Blood Pressure | DBP, Week 12, n=58, 90, 88 | -0.3 Millimeters of Mercury (mmHg) | Standard Deviation 8.09 |
| FF/GW642444 100/25 µg | Change From Baseline in Blood Pressure | DBP, Week 24, n=58, 83, 86 | -0.7 Millimeters of Mercury (mmHg) | Standard Deviation 8.46 |
| FF/GW642444 100/25 µg | Change From Baseline in Blood Pressure | DBP, Week 52/WD, n=60, 92, 89 | -0.1 Millimeters of Mercury (mmHg) | Standard Deviation 8.55 |
| FF/GW642444 200/25 µg | Change From Baseline in Blood Pressure | DBP, Week 52/WD, n=60, 92, 89 | 1.5 Millimeters of Mercury (mmHg) | Standard Deviation 10.13 |
| FF/GW642444 200/25 µg | Change From Baseline in Blood Pressure | SBP, Week 12, n=58, 90, 88 | 1.2 Millimeters of Mercury (mmHg) | Standard Deviation 11.42 |
| FF/GW642444 200/25 µg | Change From Baseline in Blood Pressure | DBP, Week 12, n=58, 90, 88 | 1.0 Millimeters of Mercury (mmHg) | Standard Deviation 8.63 |
| FF/GW642444 200/25 µg | Change From Baseline in Blood Pressure | DBP, Week 24, n=58, 83, 86 | 0.5 Millimeters of Mercury (mmHg) | Standard Deviation 9.43 |
| FF/GW642444 200/25 µg | Change From Baseline in Blood Pressure | SBP, Week 24, n=58, 83, 86 | -1.6 Millimeters of Mercury (mmHg) | Standard Deviation 12.88 |
| FF/GW642444 200/25 µg | Change From Baseline in Blood Pressure | SBP Week 52/WD, n=60, 92, 89 | 0.5 Millimeters of Mercury (mmHg) | Standard Deviation 11.95 |
| FF 100 µg | Change From Baseline in Blood Pressure | SBP, Week 24, n=58, 83, 86 | 0.1 Millimeters of Mercury (mmHg) | Standard Deviation 9.39 |
| FF 100 µg | Change From Baseline in Blood Pressure | SBP Week 52/WD, n=60, 92, 89 | 0.9 Millimeters of Mercury (mmHg) | Standard Deviation 11.66 |
| FF 100 µg | Change From Baseline in Blood Pressure | DBP, Week 52/WD, n=60, 92, 89 | -0.1 Millimeters of Mercury (mmHg) | Standard Deviation 9.2 |
| FF 100 µg | Change From Baseline in Blood Pressure | DBP, Week 12, n=58, 90, 88 | -2.3 Millimeters of Mercury (mmHg) | Standard Deviation 9.28 |
| FF 100 µg | Change From Baseline in Blood Pressure | SBP, Week 12, n=58, 90, 88 | 0.7 Millimeters of Mercury (mmHg) | Standard Deviation 13.01 |
| FF 100 µg | Change From Baseline in Blood Pressure | DBP, Week 24, n=58, 83, 86 | -1.1 Millimeters of Mercury (mmHg) | Standard Deviation 7.82 |
Secondary
Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment
Change from Baseline in AM and PM PEF at 52 weeks of evaluation period during study treatment was recorded in the dairy record card. The Baseline value was calculated as the mean of all available data recorded during the7 days immediately prior to the treatment start date (including Day 1: Day 1 is treatment start date). The PEF is defined as the greatest rate of airflow that can be achieved during forced exhalation beginning with the lungs fully inflated.
Time frame: Baseline up to Week 52
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/GW642444 100/25 µg | Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment | PEF AM, Week 0-52 | 18.29 Litres per Minute (L/min) | Standard Deviation 36.304 |
| FF/GW642444 100/25 µg | Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment | PEF PM, Week 0-52 | 20.23 Litres per Minute (L/min) | Standard Deviation 35.274 |
| FF/GW642444 200/25 µg | Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment | PEF AM, Week 0-52 | 23.98 Litres per Minute (L/min) | Standard Deviation 38.668 |
| FF/GW642444 200/25 µg | Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment | PEF PM, Week 0-52 | 26.29 Litres per Minute (L/min) | Standard Deviation 40.51 |
| FF 100 µg | Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment | PEF AM, Week 0-52 | 12.38 Litres per Minute (L/min) | Standard Deviation 32.295 |
| FF 100 µg | Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment | PEF PM, Week 0-52 | 15.64 Litres per Minute (L/min) | Standard Deviation 30.772 |
Secondary
Change From Baseline in Heart Rate (HR)
Heart rate was measured in a sitting position after a participant was kept at rest for at least 5 minutes at Baseline (Week 0), Weeks 12, 24 and Week 52/WD. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline (Week 0), Week 12, Week 24, and Week 52/WD
Population: ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/GW642444 100/25 µg | Change From Baseline in Heart Rate (HR) | Week 24, n=58, 83, 86 | 0.1 Beats/Minute | Standard Deviation 9.24 |
| FF/GW642444 100/25 µg | Change From Baseline in Heart Rate (HR) | Week 12, n=58, 90, 88 | 0.9 Beats/Minute | Standard Deviation 12.27 |
| FF/GW642444 100/25 µg | Change From Baseline in Heart Rate (HR) | Week 52/WD, n=60, 92, 89 | -1.2 Beats/Minute | Standard Deviation 10.91 |
| FF/GW642444 200/25 µg | Change From Baseline in Heart Rate (HR) | Week 24, n=58, 83, 86 | 0.1 Beats/Minute | Standard Deviation 9.18 |
| FF/GW642444 200/25 µg | Change From Baseline in Heart Rate (HR) | Week 12, n=58, 90, 88 | -0.6 Beats/Minute | Standard Deviation 9.02 |
| FF/GW642444 200/25 µg | Change From Baseline in Heart Rate (HR) | Week 52/WD, n=60, 92, 89 | -1.4 Beats/Minute | Standard Deviation 9.62 |
| FF 100 µg | Change From Baseline in Heart Rate (HR) | Week 12, n=58, 90, 88 | 1.3 Beats/Minute | Standard Deviation 8.54 |
| FF 100 µg | Change From Baseline in Heart Rate (HR) | Week 52/WD, n=60, 92, 89 | 1.1 Beats/Minute | Standard Deviation 9.1 |
| FF 100 µg | Change From Baseline in Heart Rate (HR) | Week 24, n=58, 83, 86 | 1.1 Beats/Minute | Standard Deviation 9.97 |
Secondary
Change From Baseline in the 24-hour Urinary Cortisol Excretion
Urine samples were collected for measurement of urinary cortisol excretion at the following scheduled time points: Baseline (Week 0), Week 24, and Week 52/WD. The 24-hour urinary cortisol excretion was calculated by multiplying the total volume of urine by the concentration of urinary cortisol. Cortisol is a hormone released from the adrenal gland that helps in fat, protein, and carbohydrate metabolism. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.
Time frame: Baseline (Week 0), Week 24, and Week 52/WD
Population: Urine cortisol (UC) Population: all participants in the ITT Population from whom urine specimens were collected and who were considered not to have any confounding factors that might affect the analysis of the results of the specimens. Only those participants with post-Baseline data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| FF/GW642444 100/25 µg | Change From Baseline in the 24-hour Urinary Cortisol Excretion | Week 24, n=19, 20, 28 | 1.0218 Nanomoles (nmol)/24 hours | Geometric Coefficient of Variation 42.309 |
| FF/GW642444 100/25 µg | Change From Baseline in the 24-hour Urinary Cortisol Excretion | Week 52/WD, n=18, 19, 30 | 0.8956 Nanomoles (nmol)/24 hours | Geometric Coefficient of Variation 48.231 |
| FF/GW642444 200/25 µg | Change From Baseline in the 24-hour Urinary Cortisol Excretion | Week 24, n=19, 20, 28 | 1.0602 Nanomoles (nmol)/24 hours | Geometric Coefficient of Variation 64.825 |
| FF/GW642444 200/25 µg | Change From Baseline in the 24-hour Urinary Cortisol Excretion | Week 52/WD, n=18, 19, 30 | 1.0802 Nanomoles (nmol)/24 hours | Geometric Coefficient of Variation 73.912 |
| FF 100 µg | Change From Baseline in the 24-hour Urinary Cortisol Excretion | Week 24, n=19, 20, 28 | 0.9698 Nanomoles (nmol)/24 hours | Geometric Coefficient of Variation 67.211 |
| FF 100 µg | Change From Baseline in the 24-hour Urinary Cortisol Excretion | Week 52/WD, n=18, 19, 30 | 0.8190 Nanomoles (nmol)/24 hours | Geometric Coefficient of Variation 41.301 |
Secondary
Change From Baseline in the Percentage of Rescue-free 24-hour Periods
The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered as a rescue free period. Change from Baseline is calculated as the value at Week 52 minus the value at Baseline.
Time frame: Baseline up to Week 52
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/GW642444 100/25 µg | Change From Baseline in the Percentage of Rescue-free 24-hour Periods | Week 37-52, n=57, 79, 86 | 98.38 Percentage of rescue free 24-hour period | Standard Deviation 7.253 |
| FF/GW642444 100/25 µg | Change From Baseline in the Percentage of Rescue-free 24-hour Periods | Week 25-36, n=58, 84, 87 | 97.99 Percentage of rescue free 24-hour period | Standard Deviation 8.757 |
| FF/GW642444 100/25 µg | Change From Baseline in the Percentage of Rescue-free 24-hour Periods | Week 0-12, n=60, 93, 90 | 97.94 Percentage of rescue free 24-hour period | Standard Deviation 9.553 |
| FF/GW642444 100/25 µg | Change From Baseline in the Percentage of Rescue-free 24-hour Periods | Week 13-24, n=58, 91, 88 | 97.60 Percentage of rescue free 24-hour period | Standard Deviation 7.521 |
| FF/GW642444 100/25 µg | Change From Baseline in the Percentage of Rescue-free 24-hour Periods | Week 0-52, n=60, 93, 90 | 98.01 Percentage of rescue free 24-hour period | Standard Deviation 7.736 |
| FF/GW642444 200/25 µg | Change From Baseline in the Percentage of Rescue-free 24-hour Periods | Week 25-36, n=58, 84, 87 | 95.24 Percentage of rescue free 24-hour period | Standard Deviation 14.685 |
| FF/GW642444 200/25 µg | Change From Baseline in the Percentage of Rescue-free 24-hour Periods | Week 0-12, n=60, 93, 90 | 95.51 Percentage of rescue free 24-hour period | Standard Deviation 16.427 |
| FF/GW642444 200/25 µg | Change From Baseline in the Percentage of Rescue-free 24-hour Periods | Week 13-24, n=58, 91, 88 | 95.94 Percentage of rescue free 24-hour period | Standard Deviation 13.477 |
| FF/GW642444 200/25 µg | Change From Baseline in the Percentage of Rescue-free 24-hour Periods | Week 37-52, n=57, 79, 86 | 95.71 Percentage of rescue free 24-hour period | Standard Deviation 13.382 |
| FF/GW642444 200/25 µg | Change From Baseline in the Percentage of Rescue-free 24-hour Periods | Week 0-52, n=60, 93, 90 | 95.76 Percentage of rescue free 24-hour period | Standard Deviation 13.556 |
| FF 100 µg | Change From Baseline in the Percentage of Rescue-free 24-hour Periods | Week 0-52, n=60, 93, 90 | 94.28 Percentage of rescue free 24-hour period | Standard Deviation 15.169 |
| FF 100 µg | Change From Baseline in the Percentage of Rescue-free 24-hour Periods | Week 37-52, n=57, 79, 86 | 95.13 Percentage of rescue free 24-hour period | Standard Deviation 14.705 |
| FF 100 µg | Change From Baseline in the Percentage of Rescue-free 24-hour Periods | Week 0-12, n=60, 93, 90 | 92.79 Percentage of rescue free 24-hour period | Standard Deviation 17.462 |
| FF 100 µg | Change From Baseline in the Percentage of Rescue-free 24-hour Periods | Week 25-36, n=58, 84, 87 | 94.14 Percentage of rescue free 24-hour period | Standard Deviation 15.713 |
| FF 100 µg | Change From Baseline in the Percentage of Rescue-free 24-hour Periods | Week 13-24, n=58, 91, 88 | 94.35 Percentage of rescue free 24-hour period | Standard Deviation 16.99 |
Secondary
Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the Study Treatment
Participants who were symptom free for 24-hours were assessed. Change from Baseline is calculated as the value at Week 52 minus the value at Baseline.
Time frame: Baseline up to Week 52
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FF/GW642444 100/25 µg | Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the Study Treatment | 6.79 Percentage of symptom-free days | Standard Deviation 20.382 |
| FF/GW642444 200/25 µg | Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the Study Treatment | 6.51 Percentage of symptom-free days | Standard Deviation 28.29 |
| FF 100 µg | Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the Study Treatment | 8.19 Percentage of symptom-free days | Standard Deviation 26.975 |
Secondary
Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Time frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Population: ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/GW642444 100/25 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Albumin, Baseline, n=60, 93, 90 | 44.3 g/L | Standard Deviation 2.72 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Albumin, Week 12, n=58, 90, 87 | 44.3 g/L | Standard Deviation 2.37 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Albumin, Week 24, n=58, 83, 86 | 43.6 g/L | Standard Deviation 2.52 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Albumin, Week 52/WD, n=60, 90, 89 | 43.5 g/L | Standard Deviation 2.49 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | TP, Baseline, n=60, 93, 90 | 73.3 g/L | Standard Deviation 4.36 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | TP, Week 12, n=58, 90, 87 | 73.8 g/L | Standard Deviation 3.7 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | TP, Week 24, n=58, 83, 86 | 72.3 g/L | Standard Deviation 4.49 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | TP, Week 52/WD, n=60, 90, 89 | 71.5 g/L | Standard Deviation 3.55 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Albumin, Week 24, n=58, 83, 86 | 43.9 g/L | Standard Deviation 2.67 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | TP, Week 24, n=58, 83, 86 | 72.4 g/L | Standard Deviation 3.92 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Albumin, Week 52/WD, n=60, 90, 89 | 43.4 g/L | Standard Deviation 3.03 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | TP, Baseline, n=60, 93, 90 | 73.6 g/L | Standard Deviation 3.62 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | TP, Week 12, n=58, 90, 87 | 73.0 g/L | Standard Deviation 3.83 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Albumin, Baseline, n=60, 93, 90 | 44.8 g/L | Standard Deviation 2.59 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Albumin, Week 12, n=58, 90, 87 | 44.1 g/L | Standard Deviation 2.66 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | TP, Week 52/WD, n=60, 90, 89 | 71.4 g/L | Standard Deviation 3.6 |
| FF 100 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Albumin, Week 24, n=58, 83, 86 | 43.7 g/L | Standard Deviation 2.69 |
| FF 100 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Albumin, Week 12, n=58, 90, 87 | 44.3 g/L | Standard Deviation 2.69 |
| FF 100 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Albumin, Baseline, n=60, 93, 90 | 44.7 g/L | Standard Deviation 2.86 |
| FF 100 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Albumin, Week 52/WD, n=60, 90, 89 | 43.8 g/L | Standard Deviation 2.72 |
| FF 100 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | TP, Week 24, n=58, 83, 86 | 73.3 g/L | Standard Deviation 3.78 |
| FF 100 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | TP, Week 12, n=58, 90, 87 | 74.4 g/L | Standard Deviation 4.56 |
| FF 100 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | TP, Baseline, n=60, 93, 90 | 74.6 g/L | Standard Deviation 4.08 |
| FF 100 µg | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | TP, Week 52/WD, n=60, 90, 89 | 72.5 g/L | Standard Deviation 4.15 |
Secondary
Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD
Blood samples were collected for measurement at the following scheduled time points: Baseline (BL) (Week -2), Week 12, Week 24 and Week 52/WD.
Time frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Population: ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | LDH, Week 24, n=58, 83, 86 | 175.3 International unit per liter (IU/L) | Standard Deviation 29.35 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | Creatine Kinase, Baseline, n=60, 93, 90 | 111.9 International unit per liter (IU/L) | Standard Deviation 56.95 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | ALT, Baseline, n=60, 93, 90 | 19.0 International unit per liter (IU/L) | Standard Deviation 9.69 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | LDH, Baseline, n=60, 93, 90 | 176.7 International unit per liter (IU/L) | Standard Deviation 23.78 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AST, Week 52/WD, n=60, 90, 89 | 23.5 International unit per liter (IU/L) | Standard Deviation 9.47 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | ALT, Week 12, n=58, 90, 87 | 24.1 International unit per liter (IU/L) | Standard Deviation 23.12 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | GGT, Week 24, n=58, 83, 86 | 24.7 International unit per liter (IU/L) | Standard Deviation 14.73 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AST, Week 12, n=58, 90, 87 | 23.2 International unit per liter (IU/L) | Standard Deviation 10.08 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | ALT, Week 24, n=58, 83, 86 | 19.0 International unit per liter (IU/L) | Standard Deviation 11.52 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | LDH, Week 52/WD, n=60, 90, 89 | 179.5 International unit per liter (IU/L) | Standard Deviation 31.5 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AST, Baseline, n=60, 93, 90 | 20.0 International unit per liter (IU/L) | Standard Deviation 5.48 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | ALT, Week 52/WD, n=60, 90, 89 | 21.8 International unit per liter (IU/L) | Standard Deviation 12.46 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | LDH, Week 12, n=58, 90, 87 | 180.8 International unit per liter (IU/L) | Standard Deviation 32.66 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | GGT, Week 12, n=58, 90, 87 | 28.1 International unit per liter (IU/L) | Standard Deviation 15.29 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AP, Baseline, n=60, 93, 90 | 209.9 International unit per liter (IU/L) | Standard Deviation 57.34 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AST, Week 24, n=58, 83, 86 | 20.1 International unit per liter (IU/L) | Standard Deviation 5.72 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | GGT, Baseline, n=60, 93, 90 | 25.4 International unit per liter (IU/L) | Standard Deviation 14.04 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AP, Week 12, n=58, 90, 87 | 217.9 International unit per liter (IU/L) | Standard Deviation 56.39 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | Creatine Kinase, Week 52/WD, n=60, 90, 89 | 105.3 International unit per liter (IU/L) | Standard Deviation 48.78 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | Creatine Kinase, Week 24, n=58, 83, 86 | 115.4 International unit per liter (IU/L) | Standard Deviation 77.09 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AP, Week 24, n=58, 83, 86 | 212.3 International unit per liter (IU/L) | Standard Deviation 59.48 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | GGT, Week 52/WD, n=60, 90, 89 | 28.2 International unit per liter (IU/L) | Standard Deviation 16.85 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | Creatine Kinase, Week 12, n=58, 90, 87 | 118.9 International unit per liter (IU/L) | Standard Deviation 84.32 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AP, Week 52/WD, n=60, 90, 89 | 223.1 International unit per liter (IU/L) | Standard Deviation 64.76 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AP, Week 12, n=58, 90, 87 | 214.9 International unit per liter (IU/L) | Standard Deviation 56.73 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | GGT, Week 24, n=58, 83, 86 | 30.8 International unit per liter (IU/L) | Standard Deviation 39.66 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | LDH, Baseline, n=60, 93, 90 | 186.9 International unit per liter (IU/L) | Standard Deviation 34.4 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | LDH, Week 12, n=58, 90, 87 | 185.7 International unit per liter (IU/L) | Standard Deviation 37.83 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | LDH, Week 24, n=58, 83, 86 | 184.4 International unit per liter (IU/L) | Standard Deviation 36.45 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | LDH, Week 52/WD, n=60, 90, 89 | 188.1 International unit per liter (IU/L) | Standard Deviation 39.96 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AP, Baseline, n=60, 93, 90 | 222.7 International unit per liter (IU/L) | Standard Deviation 62.97 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AP, Week 24, n=58, 83, 86 | 216.4 International unit per liter (IU/L) | Standard Deviation 57.33 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AP, Week 52/WD, n=60, 90, 89 | 219.9 International unit per liter (IU/L) | Standard Deviation 60.27 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | ALT, Baseline, n=60, 93, 90 | 22.3 International unit per liter (IU/L) | Standard Deviation 14.46 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | ALT, Week 12, n=58, 90, 87 | 21.3 International unit per liter (IU/L) | Standard Deviation 11.39 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | ALT, Week 24, n=58, 83, 86 | 20.7 International unit per liter (IU/L) | Standard Deviation 10.45 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | ALT, Week 52/WD, n=60, 90, 89 | 23.2 International unit per liter (IU/L) | Standard Deviation 13.52 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AST, Baseline, n=60, 93, 90 | 22.0 International unit per liter (IU/L) | Standard Deviation 7.5 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AST, Week 12, n=58, 90, 87 | 22.0 International unit per liter (IU/L) | Standard Deviation 7.59 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AST, Week 24, n=58, 83, 86 | 21.2 International unit per liter (IU/L) | Standard Deviation 7.29 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AST, Week 52/WD, n=60, 90, 89 | 23.3 International unit per liter (IU/L) | Standard Deviation 7.53 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | Creatine Kinase, Baseline, n=60, 93, 90 | 149.8 International unit per liter (IU/L) | Standard Deviation 134.73 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | Creatine Kinase, Week 12, n=58, 90, 87 | 134.0 International unit per liter (IU/L) | Standard Deviation 114.92 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | Creatine Kinase, Week 24, n=58, 83, 86 | 131.9 International unit per liter (IU/L) | Standard Deviation 118.86 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | Creatine Kinase, Week 52/WD, n=60, 90, 89 | 126.6 International unit per liter (IU/L) | Standard Deviation 105.24 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | GGT, Baseline, n=60, 93, 90 | 34.9 International unit per liter (IU/L) | Standard Deviation 42.7 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | GGT, Week 12, n=58, 90, 87 | 31.0 International unit per liter (IU/L) | Standard Deviation 32.21 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | GGT, Week 52/WD, n=60, 90, 89 | 34.6 International unit per liter (IU/L) | Standard Deviation 48.03 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AP, Week 52/WD, n=60, 90, 89 | 217.0 International unit per liter (IU/L) | Standard Deviation 57.89 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | GGT, Week 12, n=58, 90, 87 | 28.2 International unit per liter (IU/L) | Standard Deviation 24.6 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | Creatine Kinase, Baseline, n=60, 93, 90 | 104.0 International unit per liter (IU/L) | Standard Deviation 45.88 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AP, Week 24, n=58, 83, 86 | 215.9 International unit per liter (IU/L) | Standard Deviation 58.96 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | LDH, Week 24, n=58, 83, 86 | 174.3 International unit per liter (IU/L) | Standard Deviation 27.84 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | Creatine Kinase, Week 12, n=58, 90, 87 | 97.4 International unit per liter (IU/L) | Standard Deviation 39.32 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AP, Week 12, n=58, 90, 87 | 220.3 International unit per liter (IU/L) | Standard Deviation 59.92 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | GGT, Week 24, n=58, 83, 86 | 26.5 International unit per liter (IU/L) | Standard Deviation 22.28 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | Creatine Kinase, Week 24, n=58, 83, 86 | 103.0 International unit per liter (IU/L) | Standard Deviation 58.4 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AST, Week 12, n=58, 90, 87 | 21.7 International unit per liter (IU/L) | Standard Deviation 6.9 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | LDH, Week 12, n=58, 90, 87 | 175.1 International unit per liter (IU/L) | Standard Deviation 28.03 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | Creatine Kinase, Week 52/WD, n=60, 90, 89 | 99.9 International unit per liter (IU/L) | Standard Deviation 48.96 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AP, Baseline, n=60, 93, 90 | 217.1 International unit per liter (IU/L) | Standard Deviation 64.13 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | ALT, Week 52/WD, n=60, 90, 89 | 23.0 International unit per liter (IU/L) | Standard Deviation 14.11 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | ALT, Week 24, n=58, 83, 86 | 20.1 International unit per liter (IU/L) | Standard Deviation 10.35 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | LDH, Baseline, n=60, 93, 90 | 175.3 International unit per liter (IU/L) | Standard Deviation 27.97 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AST, Baseline, n=60, 93, 90 | 21.5 International unit per liter (IU/L) | Standard Deviation 8.99 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | ALT, Week 12, n=58, 90, 87 | 20.7 International unit per liter (IU/L) | Standard Deviation 11.44 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | GGT, Baseline, n=60, 93, 90 | 30.0 International unit per liter (IU/L) | Standard Deviation 28.96 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | LDH, Week 52/WD, n=60, 90, 89 | 177.9 International unit per liter (IU/L) | Standard Deviation 29.66 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AST, Week 24, n=58, 83, 86 | 20.6 International unit per liter (IU/L) | Standard Deviation 6.02 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | ALT, Baseline, n=60, 93, 90 | 21.9 International unit per liter (IU/L) | Standard Deviation 16.43 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | GGT, Week 52/WD, n=60, 90, 89 | 28.9 International unit per liter (IU/L) | Standard Deviation 24.59 |
| FF 100 µg | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | AST, Week 52/WD, n=60, 90, 89 | 22.8 International unit per liter (IU/L) | Standard Deviation 6.75 |
Secondary
Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Time frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Population: ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | direct [BD], Baseline, n=60, 93, 90 | 3.220 Micromoles per Liter (µmol/L) | Standard Deviation 1.4459 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Creatinine, Week 12, n=58, 90, 87 | 59.3042 Micromoles per Liter (µmol/L) | Standard Deviation 13.92743 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | total [BT], Week 12, n=58, 90, 87 | 9.965 Micromoles per Liter (µmol/L) | Standard Deviation 4.1781 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | direct [BD], Week 52/WD, n=60, 90, 89 | 2.850 Micromoles per Liter (µmol/L) | Standard Deviation 1.2057 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Creatinine, Baseline, n=60, 93, 90 | 61.8800 Micromoles per Liter (µmol/L) | Standard Deviation 13.37091 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | total [BT], Week 24, n=58, 83, 86 | 11.056 Micromoles per Liter (µmol/L) | Standard Deviation 6.4954 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | direct [BD], Week 12, n=58, 90, 87 | 2.948 Micromoles per Liter (µmol/L) | Standard Deviation 1.2729 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | total [BT], Week 52/WD, n=60, 90, 89 | 9.491 Micromoles per Liter (µmol/L) | Standard Deviation 3.6503 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Uric acid, Week 12, n=58, 90, 87 | 302.6301 Micromoles per Liter (µmol/L) | Standard Deviation 86.10161 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | indirect [BI], Week 24, n=58, 83, 86 | 7.842 Micromoles per Liter (µmol/L) | Standard Deviation 5.1553 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | indirect [BI], Baseline, n=60, 93, 90 | 7.495 Micromoles per Liter (µmol/L) | Standard Deviation 2.9883 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | indirect [BI], Week 52/WD, n=60, 90, 89 | 6.640 Micromoles per Liter (µmol/L) | Standard Deviation 2.71 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Uric acid, Week 24, n=58, 83, 86 | 299.6561 Micromoles per Liter (µmol/L) | Standard Deviation 78.45023 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Uric acid, Baseline, n=60, 93, 90 | 304.0419 Micromoles per Liter (µmol/L) | Standard Deviation 90.67062 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | indirect [BI], Week 12, n=58, 90, 87 | 7.017 Micromoles per Liter (µmol/L) | Standard Deviation 3.1004 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | direct [BD], Week 24, n=58, 83, 86 | 3.214 Micromoles per Liter (µmol/L) | Standard Deviation 1.5717 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Creatinine, Week 52/WD, n=60, 90, 89 | 60.4067 Micromoles per Liter (µmol/L) | Standard Deviation 12.52458 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Uric acid, Week 52/WD, n=60, 90, 89 | 305.2315 Micromoles per Liter (µmol/L) | Standard Deviation 78.61596 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Creatinine, Week 24, n=58, 83, 86 | 59.7614 Micromoles per Liter (µmol/L) | Standard Deviation 12.91371 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | total [BT], Baseline, n=60, 93, 90 | 10.716 Micromoles per Liter (µmol/L) | Standard Deviation 4.1989 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Uric acid, Week 12, n=58, 90, 87 | 301.6297 Micromoles per Liter (µmol/L) | Standard Deviation 74.72395 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | direct [BD], Baseline, n=60, 93, 90 | 3.236 Micromoles per Liter (µmol/L) | Standard Deviation 1.5838 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | direct [BD], Week 24, n=58, 83, 86 | 3.338 Micromoles per Liter (µmol/L) | Standard Deviation 1.8484 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | direct [BD], Week 52/WD, n=60, 90, 89 | 3.344 Micromoles per Liter (µmol/L) | Standard Deviation 1.5574 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | indirect [BI], Baseline, n=60, 93, 90 | 7.079 Micromoles per Liter (µmol/L) | Standard Deviation 3.3788 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | indirect [BI], Week 12, n=58, 90, 87 | 7.600 Micromoles per Liter (µmol/L) | Standard Deviation 3.2131 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | indirect [BI], Week 52/WD, n=60, 90, 89 | 7.505 Micromoles per Liter (µmol/L) | Standard Deviation 3.5676 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | total [BT], Baseline, n=60, 93, 90 | 10.315 Micromoles per Liter (µmol/L) | Standard Deviation 4.7735 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | total [BT], Week 12, n=58, 90, 87 | 10.830 Micromoles per Liter (µmol/L) | Standard Deviation 4.5424 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | total [BT], Week 24, n=58, 83, 86 | 11.084 Micromoles per Liter (µmol/L) | Standard Deviation 5.4427 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | direct [BD], Week 12, n=58, 90, 87 | 3.230 Micromoles per Liter (µmol/L) | Standard Deviation 1.5475 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | indirect [BI], Week 24, n=58, 83, 86 | 7.747 Micromoles per Liter (µmol/L) | Standard Deviation 3.742 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | total [BT], Week 52/WD, n=60, 90, 89 | 10.849 Micromoles per Liter (µmol/L) | Standard Deviation 4.8513 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Creatinine, Baseline, n=60, 93, 90 | 66.4806 Micromoles per Liter (µmol/L) | Standard Deviation 15.94483 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Creatinine, Week 12, n=58, 90, 87 | 62.9408 Micromoles per Liter (µmol/L) | Standard Deviation 15.71444 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Creatinine, Week 24, n=58, 83, 86 | 64.5213 Micromoles per Liter (µmol/L) | Standard Deviation 15.90631 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Creatinine, Week 52/WD, n=60, 90, 89 | 64.6204 Micromoles per Liter (µmol/L) | Standard Deviation 16.01762 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Uric acid, Baseline, n=60, 93, 90 | 305.7784 Micromoles per Liter (µmol/L) | Standard Deviation 78.88104 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Uric acid, Week 24, n=58, 83, 86 | 310.8726 Micromoles per Liter (µmol/L) | Standard Deviation 86.38513 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Uric acid, Week 52/WD, n=60, 90, 89 | 300.3079 Micromoles per Liter (µmol/L) | Standard Deviation 82.30325 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | direct [BD], Week 12, n=58, 90, 87 | 3.125 Micromoles per Liter (µmol/L) | Standard Deviation 1.6535 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Creatinine, Week 12, n=58, 90, 87 | 60.1628 Micromoles per Liter (µmol/L) | Standard Deviation 13.02866 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | indirect [BI], Week 52/WD, n=60, 90, 89 | 6.936 Micromoles per Liter (µmol/L) | Standard Deviation 3.4525 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Uric acid, Week 52/WD, n=60, 90, 89 | 308.0262 Micromoles per Liter (µmol/L) | Standard Deviation 92.43123 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Creatinine, Week 24, n=58, 83, 86 | 60.6773 Micromoles per Liter (µmol/L) | Standard Deviation 13.02242 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | indirect [BI], Week 12, n=58, 90, 87 | 6.938 Micromoles per Liter (µmol/L) | Standard Deviation 3.0451 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Uric acid, Week 24, n=58, 83, 86 | 308.5352 Micromoles per Liter (µmol/L) | Standard Deviation 91.73313 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Creatinine, Week 52/WD, n=60, 90, 89 | 61.3536 Micromoles per Liter (µmol/L) | Standard Deviation 14.3866 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | indirect [BI], Baseline, n=60, 93, 90 | 7.125 Micromoles per Liter (µmol/L) | Standard Deviation 2.8688 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | direct [BD], Baseline, n=60, 93, 90 | 3.401 Micromoles per Liter (µmol/L) | Standard Deviation 1.7851 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Uric acid, Baseline, n=60, 93, 90 | 310.6178 Micromoles per Liter (µmol/L) | Standard Deviation 96.11471 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | direct [BD], Week 52/WD, n=60, 90, 89 | 3.055 Micromoles per Liter (µmol/L) | Standard Deviation 1.5569 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | indirect [BI], Week 24, n=58, 83, 86 | 6.760 Micromoles per Liter (µmol/L) | Standard Deviation 3.2222 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | total [BT], Week 24, n=58, 83, 86 | 9.663 Micromoles per Liter (µmol/L) | Standard Deviation 4.4958 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | direct [BD], Week 24, n=58, 83, 86 | 2.903 Micromoles per Liter (µmol/L) | Standard Deviation 1.597 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | total [BT], Week 52/WD, n=60, 90, 89 | 9.991 Micromoles per Liter (µmol/L) | Standard Deviation 4.7177 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | total [BT], Week 12, n=58, 90, 87 | 10.063 Micromoles per Liter (µmol/L) | Standard Deviation 4.3902 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Uric acid, Week 12, n=58, 90, 87 | 303.8266 Micromoles per Liter (µmol/L) | Standard Deviation 87.04586 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Creatinine, Baseline, n=60, 93, 90 | 62.0568 Micromoles per Liter (µmol/L) | Standard Deviation 12.65536 |
| FF 100 µg | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | total [BT], Baseline, n=60, 93, 90 | 10.526 Micromoles per Liter (µmol/L) | Standard Deviation 4.3571 |
Secondary
Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Time frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Population: ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | CO2 content/Bicarbonate, Week 24, n=58, 83, 86 | 25.4 Millimoles per Liter (mmol/L) | Standard Deviation 2.26 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Chloride, Week 12, n=58, 90, 87 | 105.9 Millimoles per Liter (mmol/L) | Standard Deviation 2.05 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Chloride, Week 24, n=58, 83, 86 | 105.4 Millimoles per Liter (mmol/L) | Standard Deviation 2.04 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Chloride, Week 52/WD, n=60, 90, 89 | 105.6 Millimoles per Liter (mmol/L) | Standard Deviation 2.19 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | CO2 content/Bicarbonate, BL, n=60, 93, 90 | 25.3 Millimoles per Liter (mmol/L) | Standard Deviation 2.02 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | CO2 content/Bicarbonate, Week 12, n=58, 90, 87 | 24.9 Millimoles per Liter (mmol/L) | Standard Deviation 2.01 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Chloride, BL, n=60, 93, 90 | 104.3 Millimoles per Liter (mmol/L) | Standard Deviation 1.97 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | CO2 content/Bicarbonate, Week 52/WD, n=60, 90, 88 | 24.9 Millimoles per Liter (mmol/L) | Standard Deviation 2.03 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Glucose, BL, n=60, 93, 90 | 5.6685 Millimoles per Liter (mmol/L) | Standard Deviation 0.88699 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Glucose, Week 12, n=58, 90, 87 | 5.5606 Millimoles per Liter (mmol/L) | Standard Deviation 1.07679 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Glucose, Week 24, n=58, 83, 86 | 5.8228 Millimoles per Liter (mmol/L) | Standard Deviation 1.41235 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Glucose, Week 52/WD, n=60, 90, 89 | 5.4455 Millimoles per Liter (mmol/L) | Standard Deviation 1.05905 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Potassium, BL, n=60, 93, 90 | 4.04 Millimoles per Liter (mmol/L) | Standard Deviation 0.279 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Potassium, Week 12, n=58, 90, 87 | 4.17 Millimoles per Liter (mmol/L) | Standard Deviation 0.282 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Potassium, Week 24, n=58, 83, 86 | 4.14 Millimoles per Liter (mmol/L) | Standard Deviation 0.326 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Potassium, Week 52/WD, n=60, 90, 89 | 4.14 Millimoles per Liter (mmol/L) | Standard Deviation 0.333 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Sodium, BL, n=60, 93, 90 | 141.2 Millimoles per Liter (mmol/L) | Standard Deviation 1.53 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Sodium, Week 12, n=58, 90, 87 | 141.1 Millimoles per Liter (mmol/L) | Standard Deviation 1.62 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Sodium, Week 24, n=58, 83, 86 | 140.9 Millimoles per Liter (mmol/L) | Standard Deviation 1.23 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Sodium, Week 52/WD, n=60, 90, 89 | 141.3 Millimoles per Liter (mmol/L) | Standard Deviation 1.42 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urea/BUN, BL, n=60, 93, 90 | 5.0658 Millimoles per Liter (mmol/L) | Standard Deviation 1.50071 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urea/BUN, Week 12, n=58, 90, 87 | 5.0792 Millimoles per Liter (mmol/L) | Standard Deviation 1.18333 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urea/BUN, Week 24, n=58, 83, 86 | 5.0177 Millimoles per Liter (mmol/L) | Standard Deviation 1.1688 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urea/BUN, Week 52/WD, n=60, 90, 89 | 4.9932 Millimoles per Liter (mmol/L) | Standard Deviation 1.28828 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urea/BUN, Week 12, n=58, 90, 87 | 4.9865 Millimoles per Liter (mmol/L) | Standard Deviation 1.23302 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Chloride, BL, n=60, 93, 90 | 104.2 Millimoles per Liter (mmol/L) | Standard Deviation 1.85 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Potassium, BL, n=60, 93, 90 | 4.13 Millimoles per Liter (mmol/L) | Standard Deviation 0.332 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Sodium, BL, n=60, 93, 90 | 141.3 Millimoles per Liter (mmol/L) | Standard Deviation 1.66 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Chloride, Week 12, n=58, 90, 87 | 105.6 Millimoles per Liter (mmol/L) | Standard Deviation 2.38 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Glucose, Week 24, n=58, 83, 86 | 5.8593 Millimoles per Liter (mmol/L) | Standard Deviation 0.97613 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urea/BUN, BL, n=60, 93, 90 | 5.0928 Millimoles per Liter (mmol/L) | Standard Deviation 1.38695 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Chloride, Week 24, n=58, 83, 86 | 105.0 Millimoles per Liter (mmol/L) | Standard Deviation 2.44 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Potassium, Week 12, n=58, 90, 87 | 4.17 Millimoles per Liter (mmol/L) | Standard Deviation 0.366 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urea/BUN, Week 24, n=58, 83, 86 | 4.9593 Millimoles per Liter (mmol/L) | Standard Deviation 1.23301 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Chloride, Week 52/WD, n=60, 90, 89 | 105.3 Millimoles per Liter (mmol/L) | Standard Deviation 2.41 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Glucose, Week 12, n=58, 90, 87 | 5.7848 Millimoles per Liter (mmol/L) | Standard Deviation 1.01409 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Sodium, Week 12, n=58, 90, 87 | 140.7 Millimoles per Liter (mmol/L) | Standard Deviation 1.81 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | CO2 content/Bicarbonate, BL, n=60, 93, 90 | 25.0 Millimoles per Liter (mmol/L) | Standard Deviation 1.84 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Potassium, Week 24, n=58, 83, 86 | 4.17 Millimoles per Liter (mmol/L) | Standard Deviation 0.39 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Glucose, Week 52/WD, n=60, 90, 89 | 5.7743 Millimoles per Liter (mmol/L) | Standard Deviation 1.00636 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | CO2 content/Bicarbonate, Week 12, n=58, 90, 87 | 24.8 Millimoles per Liter (mmol/L) | Standard Deviation 2.13 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Glucose, BL, n=60, 93, 90 | 5.7826 Millimoles per Liter (mmol/L) | Standard Deviation 0.98753 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urea/BUN, Week 52/WD, n=60, 90, 89 | 4.9869 Millimoles per Liter (mmol/L) | Standard Deviation 1.4112 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | CO2 content/Bicarbonate, Week 24, n=58, 83, 86 | 25.3 Millimoles per Liter (mmol/L) | Standard Deviation 2.33 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Potassium, Week 52/WD, n=60, 90, 89 | 4.17 Millimoles per Liter (mmol/L) | Standard Deviation 0.363 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Sodium, Week 24, n=58, 83, 86 | 141.1 Millimoles per Liter (mmol/L) | Standard Deviation 1.89 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | CO2 content/Bicarbonate, Week 52/WD, n=60, 90, 88 | 25.3 Millimoles per Liter (mmol/L) | Standard Deviation 2.14 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Sodium, Week 52/WD, n=60, 90, 89 | 141.6 Millimoles per Liter (mmol/L) | Standard Deviation 1.62 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | CO2 content/Bicarbonate, Week 52/WD, n=60, 90, 88 | 25.1 Millimoles per Liter (mmol/L) | Standard Deviation 2.04 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Glucose, BL, n=60, 93, 90 | 5.7669 Millimoles per Liter (mmol/L) | Standard Deviation 1.03176 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Glucose, Week 12, n=58, 90, 87 | 5.7647 Millimoles per Liter (mmol/L) | Standard Deviation 1.05233 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Glucose, Week 24, n=58, 83, 86 | 5.8169 Millimoles per Liter (mmol/L) | Standard Deviation 1.43353 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Sodium, Week 52/WD, n=60, 90, 89 | 141.2 Millimoles per Liter (mmol/L) | Standard Deviation 1.8 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Glucose, Week 52/WD, n=60, 90, 89 | 5.8572 Millimoles per Liter (mmol/L) | Standard Deviation 1.17153 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urea/BUN, Week 24, n=58, 83, 86 | 4.8510 Millimoles per Liter (mmol/L) | Standard Deviation 1.24616 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Potassium, BL, n=60, 93, 90 | 4.12 Millimoles per Liter (mmol/L) | Standard Deviation 0.338 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Potassium, Week 12, n=58, 90, 87 | 4.16 Millimoles per Liter (mmol/L) | Standard Deviation 0.352 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urea/BUN, BL, n=60, 93, 90 | 4.7116 Millimoles per Liter (mmol/L) | Standard Deviation 1.12591 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Potassium, Week 24, n=58, 83, 86 | 4.16 Millimoles per Liter (mmol/L) | Standard Deviation 0.331 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urea/BUN, Week 52/WD, n=60, 90, 89 | 4.7120 Millimoles per Liter (mmol/L) | Standard Deviation 1.16694 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Potassium, Week 52/WD, n=60, 90, 89 | 4.16 Millimoles per Liter (mmol/L) | Standard Deviation 0.306 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Chloride, BL, n=60, 93, 90 | 103.6 Millimoles per Liter (mmol/L) | Standard Deviation 1.6 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Chloride, Week 12, n=58, 90, 87 | 105.6 Millimoles per Liter (mmol/L) | Standard Deviation 2.14 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Sodium, BL, n=60, 93, 90 | 140.7 Millimoles per Liter (mmol/L) | Standard Deviation 1.59 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Chloride, Week 24, n=58, 83, 86 | 105.0 Millimoles per Liter (mmol/L) | Standard Deviation 2.16 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urea/BUN, Week 12, n=58, 90, 87 | 4.7973 Millimoles per Liter (mmol/L) | Standard Deviation 1.37172 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Chloride, Week 52/WD, n=60, 90, 89 | 104.8 Millimoles per Liter (mmol/L) | Standard Deviation 2.12 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | CO2 content/Bicarbonate, BL, n=60, 93, 90 | 25.2 Millimoles per Liter (mmol/L) | Standard Deviation 1.95 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Sodium, Week 12, n=58, 90, 87 | 140.8 Millimoles per Liter (mmol/L) | Standard Deviation 1.47 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | CO2 content/Bicarbonate, Week 12, n=58, 90, 87 | 25.4 Millimoles per Liter (mmol/L) | Standard Deviation 1.81 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | CO2 content/Bicarbonate, Week 24, n=58, 83, 86 | 24.8 Millimoles per Liter (mmol/L) | Standard Deviation 2.32 |
| FF 100 µg | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Sodium, Week 24, n=58, 83, 86 | 141.0 Millimoles per Liter (mmol/L) | Standard Deviation 1.69 |
Secondary
Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Time frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Population: ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/GW642444 100/25 µg | Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Week 24, n=58, 83, 86 | 0.4238 Proportions of I | Standard Deviation 0.04228 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Baseline, n=60, 93, 90 | 0.4214 Proportions of I | Standard Deviation 0.04429 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Week 12, n=58, 90, 87 | 0.4288 Proportions of I | Standard Deviation 0.04224 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Week 52/WD, n=60, 90, 89 | 0.4194 Proportions of I | Standard Deviation 0.03921 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Week 52/WD, n=60, 90, 89 | 0.4272 Proportions of I | Standard Deviation 0.04367 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Week 12, n=58, 90, 87 | 0.4325 Proportions of I | Standard Deviation 0.04199 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Baseline, n=60, 93, 90 | 0.4374 Proportions of I | Standard Deviation 0.04417 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Week 24, n=58, 83, 86 | 0.4333 Proportions of I | Standard Deviation 0.04277 |
| FF 100 µg | Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Week 52/WD, n=60, 90, 89 | 0.4215 Proportions of I | Standard Deviation 0.04138 |
| FF 100 µg | Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Baseline, n=60, 93, 90 | 0.4319 Proportions of I | Standard Deviation 0.0409 |
| FF 100 µg | Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Week 24, n=58, 83, 86 | 0.4288 Proportions of I | Standard Deviation 0.03858 |
| FF 100 µg | Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Week 12, n=58, 90, 87 | 0.4283 Proportions of I | Standard Deviation 0.0387 |
Secondary
Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Time frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Population: ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/GW642444 100/25 µg | Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD | Baseline, n=60, 93, 90 | 135.7 Grams per liter (g/L) | Standard Deviation 15.88 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD | Week 12, n=58, 90, 87 | 138.2 Grams per liter (g/L) | Standard Deviation 15.1 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD | Week 24, n=58, 83, 86 | 137.4 Grams per liter (g/L) | Standard Deviation 15.45 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD | Week 52/WD, n=60, 90, 89 | 136.4 Grams per liter (g/L) | Standard Deviation 14.16 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD | Week 52/WD, n=60, 90, 89 | 139.0 Grams per liter (g/L) | Standard Deviation 15.91 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD | Baseline, n=60, 93, 90 | 141.1 Grams per liter (g/L) | Standard Deviation 16.34 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD | Week 24, n=58, 83, 86 | 140.8 Grams per liter (g/L) | Standard Deviation 15.99 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD | Week 12, n=58, 90, 87 | 140.6 Grams per liter (g/L) | Standard Deviation 15.58 |
| FF 100 µg | Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD | Week 52/WD, n=60, 90, 89 | 136.7 Grams per liter (g/L) | Standard Deviation 15.62 |
| FF 100 µg | Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD | Week 12, n=58, 90, 87 | 139.1 Grams per liter (g/L) | Standard Deviation 14.47 |
| FF 100 µg | Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD | Week 24, n=58, 83, 86 | 139.0 Grams per liter (g/L) | Standard Deviation 14.92 |
| FF 100 µg | Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD | Baseline, n=60, 93, 90 | 138.6 Grams per liter (g/L) | Standard Deviation 15.61 |
Secondary
Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Time frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Population: ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/GW642444 100/25 µg | Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Baseline, n=60, 93, 90 | 4.557 10^12 per liter (Ti/L) | Standard Deviation 0.4987 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Week 12, n=58, 90, 87 | 4.656 10^12 per liter (Ti/L) | Standard Deviation 0.454 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Week 24, n=58, 83, 86 | 4.626 10^12 per liter (Ti/L) | Standard Deviation 0.4679 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Week 52/WD, n=60, 90, 89 | 4.603 10^12 per liter (Ti/L) | Standard Deviation 0.4469 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Week 52/WD, n=60, 90, 89 | 4.671 10^12 per liter (Ti/L) | Standard Deviation 0.5082 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Baseline, n=60, 93, 90 | 4.714 10^12 per liter (Ti/L) | Standard Deviation 0.4804 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Week 24, n=58, 83, 86 | 4.687 10^12 per liter (Ti/L) | Standard Deviation 0.4898 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Week 12, n=58, 90, 87 | 4.685 10^12 per liter (Ti/L) | Standard Deviation 0.4888 |
| FF 100 µg | Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Week 52/WD, n=60, 90, 89 | 4.664 10^12 per liter (Ti/L) | Standard Deviation 0.4643 |
| FF 100 µg | Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Week 12, n=58, 90, 87 | 4.696 10^12 per liter (Ti/L) | Standard Deviation 0.4267 |
| FF 100 µg | Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Week 24, n=58, 83, 86 | 4.681 10^12 per liter (Ti/L) | Standard Deviation 0.4357 |
| FF 100 µg | Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Baseline, n=60, 93, 90 | 4.689 10^12 per liter (Ti/L) | Standard Deviation 0.4493 |
Secondary
Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Time frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Population: ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/GW642444 100/25 µg | Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine pH, Baseline, n=60, 93, 90 | 6.33 pH | Standard Deviation 0.774 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine pH, Week 12, n=58, 90, 87 | 6.41 pH | Standard Deviation 0.726 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine pH, Week 24, n=58, 83, 86 | 6.27 pH | Standard Deviation 0.785 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine pH, Week 52/WD, n=60, 90, 89 | 6.25 pH | Standard Deviation 0.795 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine pH, Week 52/WD, n=60, 90, 89 | 6.50 pH | Standard Deviation 0.775 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine pH, Baseline, n=60, 93, 90 | 6.36 pH | Standard Deviation 0.883 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine pH, Week 24, n=58, 83, 86 | 6.40 pH | Standard Deviation 0.878 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine pH, Week 12, n=58, 90, 87 | 6.36 pH | Standard Deviation 0.798 |
| FF 100 µg | Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine pH, Week 52/WD, n=60, 90, 89 | 6.42 pH | Standard Deviation 0.847 |
| FF 100 µg | Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine pH, Week 12, n=58, 90, 87 | 6.39 pH | Standard Deviation 0.833 |
| FF 100 µg | Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine pH, Week 24, n=58, 83, 86 | 6.33 pH | Standard Deviation 0.807 |
| FF 100 µg | Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine pH, Baseline, n=60, 93, 90 | 6.46 pH | Standard Deviation 0.852 |
Secondary
Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Time frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Population: ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/GW642444 100/25 µg | Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine Specific Gravity, Baseline, n=60, 93, 90 | 1.0177 ratio of urine density to water density | Standard Deviation 0.00764 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine Specific Gravity, Week 12, n=58, 90, 87 | 1.0171 ratio of urine density to water density | Standard Deviation 0.00731 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine Specific Gravity, Week 24, n=58, 83, 86 | 1.0174 ratio of urine density to water density | Standard Deviation 0.00795 |
| FF/GW642444 100/25 µg | Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine Specific Gravity, Week 52/WD, n=60, 90, 89 | 1.0160 ratio of urine density to water density | Standard Deviation 0.00689 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine Specific Gravity, Week 52/WD, n=60, 90, 89 | 1.0159 ratio of urine density to water density | Standard Deviation 0.00755 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine Specific Gravity, Baseline, n=60, 93, 90 | 1.0177 ratio of urine density to water density | Standard Deviation 0.0083 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine Specific Gravity, Week 24, n=58, 83, 86 | 1.0180 ratio of urine density to water density | Standard Deviation 0.00755 |
| FF/GW642444 200/25 µg | Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine Specific Gravity, Week 12, n=58, 90, 87 | 1.0167 ratio of urine density to water density | Standard Deviation 0.00789 |
| FF 100 µg | Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine Specific Gravity, Week 52/WD, n=60, 90, 89 | 1.0156 ratio of urine density to water density | Standard Deviation 0.00811 |
| FF 100 µg | Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine Specific Gravity, Week 12, n=58, 90, 87 | 1.0163 ratio of urine density to water density | Standard Deviation 0.00806 |
| FF 100 µg | Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine Specific Gravity, Week 24, n=58, 83, 86 | 1.0179 ratio of urine density to water density | Standard Deviation 0.00758 |
| FF 100 µg | Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine Specific Gravity, Baseline, n=60, 93, 90 | 1.0173 ratio of urine density to water density | Standard Deviation 0.00734 |
Secondary
Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Time frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Population: ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Basophils, Week 12, n=58, 90, 87 | 0.76 Percentage | Standard Deviation 0.473 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Lymphocytes, Week 52/WD, n=60, 90, 89 | 30.01 Percentage | Standard Deviation 6.702 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Week 12, n=58, 90, 87 | 5.22 Percentage | Standard Deviation 3.257 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Basophils, Baseline, n=60,93,90 | 0.78 Percentage | Standard Deviation 0.509 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Lymphocytes , Week 24, n=58, 83, 86 | 29.06 Percentage | Standard Deviation 6.269 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Week 24, n=58, 83, 86 | 4.88 Percentage | Standard Deviation 3.678 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Monocytes, Baseline, n=60,93,90 | 5.23 Percentage | Standard Deviation 1.307 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Lymphocytes, Week 12, n=58, 90, 87 | 29.22 Percentage | Standard Deviation 6.891 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Week 52/WD, n=60, 90, 89 | 4.89 Percentage | Standard Deviation 3.981 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Week 52/WD, n=60, 90, 89 | 58.54 Percentage | Standard Deviation 8.91 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Lymphocytes, Baseline, n=60, 93, 90 | 30.49 Percentage | Standard Deviation 5.948 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Week 24, n=58, 83, 86 | 59.82 Percentage | Standard Deviation 7.893 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Baseline, n=60,93,90 | 57.91 Percentage | Standard Deviation 8.064 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Basophils, Week 24, n=58, 83, 86 | 0.74 Percentage | Standard Deviation 0.51 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Week 12, n=58, 90, 87 | 59.14 Percentage | Standard Deviation 7.785 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Monocytes, Week 52/WD, n=60, 90, 89 | 5.59 Percentage | Standard Deviation 1.637 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Basophils, Week 52/WD, n=60, 90, 89 | 0.77 Percentage | Standard Deviation 0.51 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Monocytes, Week 24, n=58, 83, 86 | 5.51 Percentage | Standard Deviation 1.571 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Monocytes, Week 12, n=58, 90, 87 | 5.65 Percentage | Standard Deviation 1.187 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Baseline, n=60,93,90 | 5.59 Percentage | Standard Deviation 4.476 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Week 12, n=58, 90, 87 | 4.01 Percentage | Standard Deviation 3.112 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Monocytes, Baseline, n=60,93,90 | 5.39 Percentage | Standard Deviation 1.408 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Monocytes, Week 24, n=58, 83, 86 | 5.52 Percentage | Standard Deviation 1.321 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Week 52/WD, n=60, 90, 89 | 61.70 Percentage | Standard Deviation 8.326 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Basophils, Baseline, n=60,93,90 | 0.71 Percentage | Standard Deviation 0.419 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Basophils, Week 12, n=58, 90, 87 | 0.67 Percentage | Standard Deviation 0.414 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Basophils, Week 24, n=58, 83, 86 | 0.66 Percentage | Standard Deviation 0.392 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Basophils, Week 52/WD, n=60, 90, 89 | 0.64 Percentage | Standard Deviation 0.383 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Baseline, n=60,93,90 | 5.03 Percentage | Standard Deviation 3.843 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Week 24, n=58, 83, 86 | 4.00 Percentage | Standard Deviation 2.753 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Week 52/WD, n=60, 90, 89 | 4.27 Percentage | Standard Deviation 3.247 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Lymphocytes, Baseline, n=60, 93, 90 | 30.95 Percentage | Standard Deviation 7.504 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Lymphocytes, Week 12, n=58, 90, 87 | 29.15 Percentage | Standard Deviation 6.378 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Lymphocytes , Week 24, n=58, 83, 86 | 28.40 Percentage | Standard Deviation 6.282 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Lymphocytes, Week 52/WD, n=60, 90, 89 | 27.67 Percentage | Standard Deviation 7.913 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Monocytes, Week 12, n=58, 90, 87 | 5.61 Percentage | Standard Deviation 1.626 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Monocytes, Week 52/WD, n=60, 90, 89 | 5.72 Percentage | Standard Deviation 1.366 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Baseline, n=60,93,90 | 57.92 Percentage | Standard Deviation 8.103 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Week 12, n=58, 90, 87 | 60.57 Percentage | Standard Deviation 7.474 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Week 24, n=58, 83, 86 | 61.37 Percentage | Standard Deviation 6.79 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Baseline, n=60,93,90 | 5.32 Percentage | Standard Deviation 3.167 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Week 12, n=58, 90, 87 | 59.31 Percentage | Standard Deviation 8.642 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Lymphocytes, Week 52/WD, n=60, 90, 89 | 29.04 Percentage | Standard Deviation 7.047 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Basophils, Week 52/WD, n=60, 90, 89 | 0.72 Percentage | Standard Deviation 0.482 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Monocytes, Baseline, n=60,93,90 | 5.35 Percentage | Standard Deviation 1.442 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Monocytes, Week 24, n=58, 83, 86 | 5.41 Percentage | Standard Deviation 1.37 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Basophils, Week 24, n=58, 83, 86 | 0.72 Percentage | Standard Deviation 0.408 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Week 52/WD, n=60, 90, 89 | 60.05 Percentage | Standard Deviation 7.883 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Monocytes, Week 52/WD, n=60, 90, 89 | 5.59 Percentage | Standard Deviation 1.516 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Basophils, Week 12, n=58, 90, 87 | 0.79 Percentage | Standard Deviation 0.542 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Week 24, n=58, 83, 86 | 60.64 Percentage | Standard Deviation 7.358 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Week 52/WD, n=60, 90, 89 | 4.60 Percentage | Standard Deviation 3.09 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Baseline, n=60,93,90 | 57.28 Percentage | Standard Deviation 7.467 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Lymphocytes, Baseline, n=60, 93, 90 | 31.26 Percentage | Standard Deviation 6.15 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Week 24, n=58, 83, 86 | 4.37 Percentage | Standard Deviation 3.061 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Monocytes, Week 12, n=58, 90, 87 | 5.65 Percentage | Standard Deviation 1.639 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Lymphocytes, Week 12, n=58, 90, 87 | 29.35 Percentage | Standard Deviation 7.274 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Week 12, n=58, 90, 87 | 4.90 Percentage | Standard Deviation 3.496 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Basophils, Baseline, n=60,93,90 | 0.79 Percentage | Standard Deviation 0.508 |
| FF 100 µg | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Lymphocytes , Week 24, n=58, 83, 86 | 28.83 Percentage | Standard Deviation 6.343 |
Secondary
Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Time frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Population: ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/GW642444 100/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Week 52/WD, n=60, 90, 89 | 3.585 10^9 per liter (Gi/L) | Standard Deviation 1.257 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Baseline, n=60, 93, 90 | 0.338 10^9 per liter (Gi/L) | Standard Deviation 0.2514 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Week 12, n=58, 90, 87 | 0.306 10^9 per liter (Gi/L) | Standard Deviation 0.2106 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Week 24, n=58, 83, 86 | 0.282 10^9 per liter (Gi/L) | Standard Deviation 0.2244 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Week 52/WD, n=60, 90, 89 | 0.290 10^9 per liter (Gi/L) | Standard Deviation 0.2399 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Platelet count, Baseline, n=60, 93, 90 | 252.4 10^9 per liter (Gi/L) | Standard Deviation 53.41 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Platelet count, Week 12, n=58, 90, 87 | 263.9 10^9 per liter (Gi/L) | Standard Deviation 62.25 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Platelet count, Week 24, n=58, 83, 86 | 261.1 10^9 per liter (Gi/L) | Standard Deviation 62.25 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Platelet count, Week 52/WD, n=60, 90, 89 | 267.2 10^9 per liter (Gi/L) | Standard Deviation 54.93 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | WBC, Baseline, n=60, 93, 90 | 6.24 10^9 per liter (Gi/L) | Standard Deviation 1.716 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | WBC, Week 12, n=58, 90, 87 | 5.90 10^9 per liter (Gi/L) | Standard Deviation 1.642 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | WBC, Week 24, n=58, 83, 86 | 5.86 10^9 per liter (Gi/L) | Standard Deviation 1.541 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | WBC, Week 52/WD, n=60, 90, 89 | 6.11 10^9 per liter (Gi/L) | Standard Deviation 1.625 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Baseline, n=60, 93, 90 | 3.661 10^9 per liter (Gi/L) | Standard Deviation 1.3444 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Week 12, n=58, 90, 87 | 3.522 10^9 per liter (Gi/L) | Standard Deviation 1.214 |
| FF/GW642444 100/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Week 24, n=58, 83, 86 | 3.522 10^9 per liter (Gi/L) | Standard Deviation 1.1186 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Platelet count, Baseline, n=60, 93, 90 | 257.1 10^9 per liter (Gi/L) | Standard Deviation 64.98 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Week 24, n=58, 83, 86 | 3.833 10^9 per liter (Gi/L) | Standard Deviation 1.2812 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Platelet count, Week 12, n=58, 90, 87 | 269.3 10^9 per liter (Gi/L) | Standard Deviation 60.55 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Baseline, n=60, 93, 90 | 3.734 10^9 per liter (Gi/L) | Standard Deviation 1.2446 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Platelet count, Week 24, n=58, 83, 86 | 270.2 10^9 per liter (Gi/L) | Standard Deviation 66.6 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Platelet count, Week 52/WD, n=60, 90, 89 | 276.7 10^9 per liter (Gi/L) | Standard Deviation 68.64 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Week 12, n=58, 90, 87 | 3.729 10^9 per liter (Gi/L) | Standard Deviation 1.1131 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | WBC, Week 12, n=58, 90, 87 | 6.11 10^9 per liter (Gi/L) | Standard Deviation 1.462 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | WBC, Week 24, n=58, 83, 86 | 6.19 10^9 per liter (Gi/L) | Standard Deviation 1.743 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Week 12, n=58, 90, 87 | 0.245 10^9 per liter (Gi/L) | Standard Deviation 0.2057 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Week 52/WD, n=60, 90, 89 | 4.010 10^9 per liter (Gi/L) | Standard Deviation 1.2422 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Baseline, n=60, 93, 90 | 0.323 10^9 per liter (Gi/L) | Standard Deviation 0.2591 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | WBC, Baseline, n=60, 93, 90 | 6.39 10^9 per liter (Gi/L) | Standard Deviation 1.503 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Week 24, n=58, 83, 86 | 0.247 10^9 per liter (Gi/L) | Standard Deviation 0.1864 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | WBC, Week 52/WD, n=60, 90, 89 | 6.45 10^9 per liter (Gi/L) | Standard Deviation 1.53 |
| FF/GW642444 200/25 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Week 52/WD, n=60, 90, 89 | 0.281 10^9 per liter (Gi/L) | Standard Deviation 0.2332 |
| FF 100 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Week 12, n=58, 90, 87 | 0.286 10^9 per liter (Gi/L) | Standard Deviation 0.2154 |
| FF 100 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Platelet count, Baseline, n=60, 93, 90 | 254.1 10^9 per liter (Gi/L) | Standard Deviation 60.77 |
| FF 100 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | WBC, Baseline, n=60, 93, 90 | 6.13 10^9 per liter (Gi/L) | Standard Deviation 1.495 |
| FF 100 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Week 52/WD, n=60, 90, 89 | 3.795 10^9 per liter (Gi/L) | Standard Deviation 1.2221 |
| FF 100 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Platelet count, Week 12, n=58, 90, 87 | 259.0 10^9 per liter (Gi/L) | Standard Deviation 54 |
| FF 100 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Week 52/WD, n=60, 90, 89 | 0.285 10^9 per liter (Gi/L) | Standard Deviation 0.2032 |
| FF 100 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | WBC, Week 52/WD, n=60, 90, 89 | 6.24 10^9 per liter (Gi/L) | Standard Deviation 1.511 |
| FF 100 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Platelet count, Week 24, n=58, 83, 86 | 260.1 10^9 per liter (Gi/L) | Standard Deviation 58.84 |
| FF 100 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Baseline, n=60, 93, 90 | 3.536 10^9 per liter (Gi/L) | Standard Deviation 1.108 |
| FF 100 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Week 24, n=58, 83, 86 | 0.256 10^9 per liter (Gi/L) | Standard Deviation 0.1907 |
| FF 100 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Platelet count, Week 52/WD, n=60, 90, 89 | 270.3 10^9 per liter (Gi/L) | Standard Deviation 63.75 |
| FF 100 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Week 24, n=58, 83, 86 | 3.690 10^9 per liter (Gi/L) | Standard Deviation 1.2837 |
| FF 100 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Eosinophils, Baseline, n=60, 93, 90 | 0.323 10^9 per liter (Gi/L) | Standard Deviation 0.2042 |
| FF 100 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | WBC, Week 24, n=58, 83, 86 | 6.01 10^9 per liter (Gi/L) | Standard Deviation 1.564 |
| FF 100 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | WBC, Week 12, n=58, 90, 87 | 5.95 10^9 per liter (Gi/L) | Standard Deviation 1.636 |
| FF 100 µg | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Total neutrophils, Week 12, n=58, 90, 87 | 3.567 10^9 per liter (Gi/L) | Standard Deviation 1.2419 |
Secondary
Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD
Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results can be read as negative (Neg), Trace (TRA), 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, trace, 1+, 2+, and 3+ levels at Baseline (Week -2) and Week 52/WD.
Time frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Population: ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 3+, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, TRA, Week 12, n=58, 90, 87 | 5 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 3+, Week 24, n=58, 83, 86 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,1+, Week 52/WD, n=60, 90, 89 | 4 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, Neg, Week 12, n=58, 90, 87 | 52 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, Neg, Week 52/WD, n=60, 90, 89 | 59 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,2+, Week 12, n=58, 90, 87 | 3 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 3+, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, TRA, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, Neg, Week 12, n=58, 90, 87 | 50 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 2+, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 1+, Week 52/WD, n=60, 90, 89 | 1 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,1+, Week 12, n=58, 90, 87 | 2 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 1+, BL, n=60, 93, 90 | 1 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 2+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 2+, Week 24, n=58, 83, 86 | 3 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, TRA, BL, n=60, 93, 90 | 4 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 3+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,3+, Week 52/WD, n=60, 90, 89 | 1 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, Neg, BL, n=60, 93, 90 | 55 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, Neg, BL, n=60, 93, 90 | 60 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,TRA, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 3+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, TRA, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,TRA, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 2+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 1+, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 3+, Week 24, n=58, 83, 86 | 1 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 1+, Week 52/WD, n=60, 90, 89 | 1 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 2+, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, TRA, Week 12, n=58, 90, 87 | 2 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, TRA, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 3+, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,Neg, Week 12, n=58, 90, 87 | 52 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, Neg, Week 52/WD, n=60, 90, 89 | 59 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, Neg, Week 12, n=58, 90, 87 | 58 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, Neg, Week 52/WD, n=60, 90, 89 | 54 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 3+, Week 24, n=58, 83, 86 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, TRA, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 2+, BL, n=60, 93, 90 | 1 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 2+, Week 24, n=58, 83, 86 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 1+, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,3+, BL, n=60, 93, 90 | 1 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 1+, Week 24, n=58, 83, 86 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 2+, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, TRA, Week 52/WD, n=60, 90, 89 | 4 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, TRA, Week 24, n=58, 83, 86 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 3+, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,Neg, Week 52/WD, n=60, 90, 89 | 52 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, Neg, Week 24, n=58, 83, 86 | 58 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,2+, BL, n=60, 93, 90 | 3 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 1+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 1+, Week 12, n=58, 90, 87 | 4 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,1+, BL, n=60, 93, 90 | 3 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 2+, Week 52/WD, n=60, 90, 89 | 1 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, TRA, BL, n=60, 93, 90 | 6 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,TRA, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 3+, Week 52/WD, n=60, 90, 89 | 1 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,3+, Week 24, n=58, 83, 86 | 2 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC, Neg, BL, n=60, 93, 90 | 53 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, Neg, BL, n=60, 93, 90 | 58 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 2+, Week 12, n=58, 90, 87 | 2 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 3+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, TRA, BL, n=60, 93, 90 | 2 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 3+, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 2+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 1+, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,2+, Week 24, n=58, 83, 86 | 2 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 1+, Week 52/WD, n=60, 90, 89 | 1 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 2+, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,2+, Week 52/WD, n=60, 90, 89 | 3 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, TRA, Week 52/WD, n=60, 90, 89 | 5 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 3+, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,1+, Week 24, n=58, 83, 86 | 4 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, Neg, Week 52/WD, n=60, 90, 89 | 54 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, Neg, Week 12, n=58, 90, 87 | 55 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, Neg, Week 24, n=58, 83, 86 | 49 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 3+, Week 24, n=58, 83, 86 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, TRA, Week 12, n=58, 90, 87 | 2 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 1+, BL, n=60, 93, 90 | 2 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 2+, Week 24, n=58, 83, 86 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 1+, Week 12, n=58, 90, 87 | 1 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,TRA, Week 24, n=58, 83, 86 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 1+, Week 24, n=58, 83, 86 | 1 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 2+, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, TRA, Week 24, n=58, 83, 86 | 4 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, TRA, Week 24, n=58, 83, 86 | 7 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 3+, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, Neg, BL, n=60, 93, 90 | 51 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, Neg, Week 24, n=58, 83, 86 | 50 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, Neg, Week 24, n=58, 83, 86 | 53 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,Neg, Week 24, n=58, 83, 86 | 50 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 3+, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, TRA, Week 24, n=58, 83, 86 | 2 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 1+, Week 24, n=58, 83, 86 | 1 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 2+, Week 12, n=58, 90, 87 | 1 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 1+, Week 24, n=58, 83, 86 | 2 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,3+, Week 12, n=58, 90, 87 | 1 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 1+, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 2+, Week 24, n=58, 83, 86 | 1 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,1+, Week 12, n=58, 90, 87 | 5 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, TRA, BL, n=60, 93, 90 | 5 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 2+, BL, n=60, 93, 90 | 3 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 1+, BL, n=60, 93, 90 | 5 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, Neg, Week 12, n=58, 90, 87 | 79 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, TRA, Week 12, n=58, 90, 87 | 4 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 1+, Week 12, n=58, 90, 87 | 2 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 2+, Week 12, n=58, 90, 87 | 3 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 3+, Week 12, n=58, 90, 87 | 2 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, Neg, Week 24, n=58, 83, 86 | 71 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, TRA, Week 24, n=58, 83, 86 | 6 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 3+, BL, n=60, 93, 90 | 1 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 1+, Week 24, n=58, 83, 86 | 1 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 2+, Week 24, n=58, 83, 86 | 3 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 3+, Week 24, n=58, 83, 86 | 2 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, Neg, Week 52/WD, n=60, 90, 89 | 76 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, TRA, Week 52/WD, n=60, 90, 89 | 4 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 1+, Week 52/WD, n=60, 90, 89 | 6 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 2+, Week 52/WD, n=60, 90, 89 | 3 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 3+, Week 52/WD, n=60, 90, 89 | 1 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, Neg, BL, n=60, 93, 90 | 93 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, TRA, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 1+, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 2+, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 3+, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, Neg, Week 12, n=58, 90, 87 | 90 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, TRA, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 1+, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 2+, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 3+, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, Neg, Week 24, n=58, 83, 86 | 80 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, TRA, Week 24, n=58, 83, 86 | 1 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 1+, Week 24, n=58, 83, 86 | 1 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 2+, Week 24, n=58, 83, 86 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 3+, Week 24, n=58, 83, 86 | 1 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, Neg, Week 52/WD, n=60, 90, 89 | 87 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, TRA, Week 52/WD, n=60, 90, 89 | 3 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 1+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 2+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 3+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, Neg, BL, n=60, 93, 90 | 93 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, TRA, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 1+, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 2+, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 3+, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, Neg, Week 12, n=58, 90, 87 | 89 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, TRA, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 1+, Week 12, n=58, 90, 87 | 1 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 2+, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 3+, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, Neg, Week 24, n=58, 83, 86 | 83 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, TRA, Week 24, n=58, 83, 86 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 1+, Week 24, n=58, 83, 86 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 2+, Week 24, n=58, 83, 86 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 3+, Week 24, n=58, 83, 86 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, Neg, Week 52/WD, n=60, 90, 89 | 90 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, TRA, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 1+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 2+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 3+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, Neg, BL, n=60, 93, 90 | 76 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, TRA, BL, n=60, 93, 90 | 16 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 1+, BL, n=60, 93, 90 | 1 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 2+, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 3+, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, Neg, Week 12, n=58, 90, 87 | 82 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, TRA, Week 12, n=58, 90, 87 | 5 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 1+, Week 12, n=58, 90, 87 | 2 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 2+, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 3+, Week 12, n=58, 90, 87 | 1 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, Neg, Week 24, n=58, 83, 86 | 73 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, TRA, Week 24, n=58, 83, 86 | 8 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 1+, Week 24, n=58, 83, 86 | 1 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 2+, Week 24, n=58, 83, 86 | 1 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 3+, Week 24, n=58, 83, 86 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, Neg, Week 52/WD, n=60, 90, 89 | 70 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, TRA, Week 52/WD, n=60, 90, 89 | 15 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 1+, Week 52/WD, n=60, 90, 89 | 4 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 2+, Week 52/WD, n=60, 90, 89 | 1 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 3+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC, Neg, BL, n=60, 93, 90 | 79 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,TRA, BL, n=60, 93, 90 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,1+, BL, n=60, 93, 90 | 7 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,2+, BL, n=60, 93, 90 | 3 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,3+, BL, n=60, 93, 90 | 4 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,Neg, Week 12, n=58, 90, 87 | 73 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,TRA, Week 12, n=58, 90, 87 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, Neg, BL, n=60, 93, 90 | 79 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,2+, Week 12, n=58, 90, 87 | 5 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,3+, Week 12, n=58, 90, 87 | 7 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,Neg, Week 24, n=58, 83, 86 | 70 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,TRA, Week 24, n=58, 83, 86 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,1+, Week 24, n=58, 83, 86 | 6 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,2+, Week 24, n=58, 83, 86 | 5 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,3+, Week 24, n=58, 83, 86 | 2 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,Neg, Week 52/WD, n=60, 90, 89 | 75 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,TRA, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,1+, Week 52/WD, n=60, 90, 89 | 6 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,2+, Week 52/WD, n=60, 90, 89 | 5 Participants |
| FF/GW642444 200/25 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,3+, Week 52/WD, n=60, 90, 89 | 4 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, TRA, Week 12, n=58, 90, 87 | 7 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 1+, Week 24, n=58, 83, 86 | 1 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 2+, BL, n=60, 93, 90 | 3 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 1+, Week 12, n=58, 90, 87 | 4 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, TRA, Week 24, n=58, 83, 86 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,2+, Week 52/WD, n=60, 90, 89 | 7 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 2+, Week 12, n=58, 90, 87 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, Neg, Week 24, n=58, 83, 86 | 82 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,3+, Week 12, n=58, 90, 87 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 3+, Week 12, n=58, 90, 87 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 3+, Week 12, n=58, 90, 87 | 3 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, TRA, Week 24, n=58, 83, 86 | 2 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, Neg, Week 24, n=58, 83, 86 | 80 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 2+, Week 12, n=58, 90, 87 | 1 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,TRA, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, TRA, Week 24, n=58, 83, 86 | 5 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 1+, Week 12, n=58, 90, 87 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,Neg, Week 24, n=58, 83, 86 | 78 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 1+, Week 24, n=58, 83, 86 | 1 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, TRA, Week 12, n=58, 90, 87 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, Neg, Week 24, n=58, 83, 86 | 78 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 2+, Week 24, n=58, 83, 86 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, Neg, Week 12, n=58, 90, 87 | 83 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, Neg, BL, n=60, 93, 90 | 81 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 3+, Week 24, n=58, 83, 86 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 3+, BL, n=60, 93, 90 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,TRA, Week 24, n=58, 83, 86 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, Neg, Week 52/WD, n=60, 90, 89 | 68 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 2+, BL, n=60, 93, 90 | 2 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 3+, Week 12, n=58, 90, 87 | 3 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, TRA, Week 52/WD, n=60, 90, 89 | 17 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 1+, BL, n=60, 93, 90 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 1+, BL, n=60, 93, 90 | 2 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 1+, Week 52/WD, n=60, 90, 89 | 2 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, TRA, BL, n=60, 93, 90 | 1 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,1+, Week 24, n=58, 83, 86 | 7 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 2+, Week 52/WD, n=60, 90, 89 | 2 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, Neg, BL, n=60, 93, 90 | 87 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 2+, Week 12, n=58, 90, 87 | 1 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 3+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 3+, Week 52/WD, n=60, 90, 89 | 2 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,1+, Week 52/WD, n=60, 90, 89 | 2 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC, Neg, BL, n=60, 93, 90 | 82 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 2+, Week 52/WD, n=60, 90, 89 | 3 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,2+, Week 24, n=58, 83, 86 | 1 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,TRA, BL, n=60, 93, 90 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 1+, Week 52/WD, n=60, 90, 89 | 1 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 1+, Week 12, n=58, 90, 87 | 3 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,1+, BL, n=60, 93, 90 | 3 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, TRA, Week 52/WD, n=60, 90, 89 | 2 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 3+, Week 12, n=58, 90, 87 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, TRA, BL, n=60, 93, 90 | 2 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, Neg, Week 24, n=58, 83, 86 | 86 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 2+, Week 12, n=58, 90, 87 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,2+, BL, n=60, 93, 90 | 2 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, TRA, Week 24, n=58, 83, 86 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 1+, Week 12, n=58, 90, 87 | 1 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, Neg, Week 52/WD, n=60, 90, 89 | 81 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 1+, Week 24, n=58, 83, 86 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, TRA, Week 12, n=58, 90, 87 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,3+, Week 24, n=58, 83, 86 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 2+, Week 24, n=58, 83, 86 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, Neg, Week 12, n=58, 90, 87 | 86 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,3+, BL, n=60, 93, 90 | 3 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 3+, Week 24, n=58, 83, 86 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 3+, BL, n=60, 93, 90 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 3+, Week 24, n=58, 83, 86 | 2 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, Neg, Week 52/WD, n=60, 90, 89 | 89 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 2+, BL, n=60, 93, 90 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, TRA, Week 12, n=58, 90, 87 | 5 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, TRA, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 1+, BL, n=60, 93, 90 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,Neg, Week 12, n=58, 90, 87 | 77 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 1+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, TRA, BL, n=60, 93, 90 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 2+, Week 24, n=58, 83, 86 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 2+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, Neg, BL, n=60, 93, 90 | 90 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,3+, Week 52/WD, n=60, 90, 89 | 2 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UK, 3+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 3+, Week 52/WD, n=60, 90, 89 | 1 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,TRA, Week 12, n=58, 90, 87 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, Neg, BL, n=60, 93, 90 | 79 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 2+, Week 52/WD, n=60, 90, 89 | 1 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 1+, Week 24, n=58, 83, 86 | 4 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, TRA, BL, n=60, 93, 90 | 9 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 1+, Week 52/WD, n=60, 90, 89 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,Neg, Week 52/WD, n=60, 90, 89 | 78 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 1+, BL, n=60, 93, 90 | 2 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, TRA, Week 52/WD, n=60, 90, 89 | 3 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,1+, Week 12, n=58, 90, 87 | 7 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 2+, BL, n=60, 93, 90 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, Neg, Week 52/WD, n=60, 90, 89 | 84 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, 3+, BL, n=60, 93, 90 | 2 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, 3+, BL, n=60, 93, 90 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 3+, Week 24, n=58, 83, 86 | 3 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UOB, Neg, Week 12, n=58, 90, 87 | 75 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UP, Neg, Week 12, n=58, 90, 87 | 76 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UG, 2+, Week 24, n=58, 83, 86 | 0 Participants |
| FF 100 µg | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | UWBC,2+, Week 12, n=58, 90, 87 | 3 Participants |
Secondary
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes at assessment time points (Baseline\[Week -2\], Week 12, 24 and Week 52/WD) in the treatment period. Data are presented for clinically significant (CS) as well as not clinically significant (NCS) abnormal (Abn) findings. Any abnormal ECG, including those that worsen from Baseline, and determined clinically significant by the assessment of the investigator were recorded as CS.
Time frame: Week 12, Week 24, and Week 52/WD
Population: ITT Population. . Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF/GW642444 100/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Baseline, Abn NCS, n=60, 93, 90 | 19 Participants |
| FF/GW642444 100/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Baseline, Abn CS, n=60, 93, 90 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 12, Abn NCS, n=58, 90, 88 | 11 Participants |
| FF/GW642444 100/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 12, Abn CS, n=58, 90, 88 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 24, Abn NCS, n=58, 83, 86 | 12 Participants |
| FF/GW642444 100/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 24, Abn CS, n=58, 83, 86 | 0 Participants |
| FF/GW642444 100/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 52/WD, Abn NCS, n=60, 90, 89 | 10 Participants |
| FF/GW642444 100/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 52/WD, Abn CS, n=60, 90, 89 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 12, Abn NCS, n=58, 90, 88 | 17 Participants |
| FF/GW642444 200/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 52/WD, Abn NCS, n=60, 90, 89 | 16 Participants |
| FF/GW642444 200/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 12, Abn CS, n=58, 90, 88 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 24, Abn NCS, n=58, 83, 86 | 18 Participants |
| FF/GW642444 200/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 24, Abn CS, n=58, 83, 86 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Baseline, Abn NCS, n=60, 93, 90 | 22 Participants |
| FF/GW642444 200/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Baseline, Abn CS, n=60, 93, 90 | 0 Participants |
| FF/GW642444 200/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 52/WD, Abn CS, n=60, 90, 89 | 2 Participants |
| FF 100 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 12, Abn NCS, n=58, 90, 88 | 10 Participants |
| FF 100 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Baseline, Abn CS, n=60, 93, 90 | 0 Participants |
| FF 100 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Baseline, Abn NCS, n=60, 93, 90 | 11 Participants |
| FF 100 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 12, Abn CS, n=58, 90, 88 | 0 Participants |
| FF 100 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 52/WD, Abn NCS, n=60, 90, 89 | 12 Participants |
| FF 100 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 24, Abn CS, n=58, 83, 86 | 0 Participants |
| FF 100 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 24, Abn NCS, n=58, 83, 86 | 9 Participants |
| FF 100 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Week 52/WD, Abn CS, n=60, 90, 89 | 0 Participants |
Secondary
Number of Participants With Severe Asthma Exacerbation During the Study Treatment
A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Courses of corticosteroids separated by 1 week or more were treated as separate severe exacerbations.
Time frame: Baseline up to Week 52
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FF/GW642444 100/25 µg | Number of Participants With Severe Asthma Exacerbation During the Study Treatment | 3 Participants |
| FF/GW642444 200/25 µg | Number of Participants With Severe Asthma Exacerbation During the Study Treatment | 9 Participants |
| FF 100 µg | Number of Participants With Severe Asthma Exacerbation During the Study Treatment | 16 Participants |
Secondary
Number of Rescue Medication Inhalations
Salbutamol inhaler was used as the rescue medication. Participants entered the number of rescue medication inhalations in the patient diary twice daily (morning and evening).
Time frame: Baseline up to Week 52
Population: ITT Population. The number of participants analyzed depends on the number of participants remaining in the indaicated time period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/GW642444 100/25 µg | Number of Rescue Medication Inhalations | Week 0-52, n=60, 93, 90 | 23.28 Number of inhalations | Standard Deviation 132.467 |
| FF/GW642444 100/25 µg | Number of Rescue Medication Inhalations | Week 37-52, n=57, 79, 86 | 7.75 Number of inhalations | Standard Deviation 50.851 |
| FF/GW642444 100/25 µg | Number of Rescue Medication Inhalations | Week 13-24, n=58, 91, 88 | 5.12 Number of inhalations | Standard Deviation 19.094 |
| FF/GW642444 100/25 µg | Number of Rescue Medication Inhalations | Week 25-36, n=58, 84, 87 | 6.02 Number of inhalations | Standard Deviation 36.358 |
| FF/GW642444 100/25 µg | Number of Rescue Medication Inhalations | Week 0-12, n=60, 93, 90 | 5.15 Number of inhalations | Standard Deviation 31.288 |
| FF/GW642444 200/25 µg | Number of Rescue Medication Inhalations | Week 25-36, n=58, 84, 87 | 7.45 Number of inhalations | Standard Deviation 25.058 |
| FF/GW642444 200/25 µg | Number of Rescue Medication Inhalations | Week 13-24, n=58, 91, 88 | 6.65 Number of inhalations | Standard Deviation 23.257 |
| FF/GW642444 200/25 µg | Number of Rescue Medication Inhalations | Week 0-12, n=60, 93, 90 | 7.32 Number of inhalations | Standard Deviation 27.667 |
| FF/GW642444 200/25 µg | Number of Rescue Medication Inhalations | Week 37-52, n=57, 79, 86 | 7.73 Number of inhalations | Standard Deviation 22.285 |
| FF/GW642444 200/25 µg | Number of Rescue Medication Inhalations | Week 0-52, n=60, 93, 90 | 27.13 Number of inhalations | Standard Deviation 90.038 |
| FF 100 µg | Number of Rescue Medication Inhalations | Week 0-52, n=60, 93, 90 | 56.23 Number of inhalations | Standard Deviation 253.508 |
| FF 100 µg | Number of Rescue Medication Inhalations | Week 37-52, n=57, 79, 86 | 17.78 Number of inhalations | Standard Deviation 97.092 |
| FF 100 µg | Number of Rescue Medication Inhalations | Week 13-24, n=58, 91, 88 | 12.56 Number of inhalations | Standard Deviation 54.154 |
| FF 100 µg | Number of Rescue Medication Inhalations | Week 25-36, n=58, 84, 87 | 14.01 Number of inhalations | Standard Deviation 70.642 |
| FF 100 µg | Number of Rescue Medication Inhalations | Week 0-12, n=60, 93, 90 | 13.42 Number of inhalations | Standard Deviation 43.889 |