Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Chronic Bronchitis, COPD, Emphysema
Brief summary
This study evaluates the safety of medicine on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 56 weeks, and subjects will visit the clinic 16 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of COPD.
Exclusion criteria
* Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD. * Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs) | Up to Week 56 | AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Up to Week 56 | Clinical chemistry parameters: Total bilirubin (TB), Alkaline phosphatase (Al-P), Alanine aminotransferase (ALT), Asparate aminotransferase (AST), Gamma-glutamyl transpeptidase (GTP), Lactate dehydrogenase (LDH), Total cholesterol (TC), Glucose, Creatinine, Blood urea nitrogen (BUN), Uric acid (UA), Sodium (Na), Potassium (K), Chloride (Cl) and Calcium (Ca) were presented as the outliers from the normal range as \> upper limit and \< lower limit. Only number of participants with clinical chemistry values outside normal range were presented. |
| Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Up to Week 56 | Urinalysis parameters: Urine protein, Glucose and Urobilinogen were presented as shift from Baseline. Only number of participants with urinalysis values more than Baseline values were presented. The plus sign increases with a higher level of glucose and proteins in the urine: 1+: slightly positive, 2+: positive, 3+: high positive and 4+: strongly positive. |
| Mean Change From Baseline in Level of Plasma Cortisol 1 | Baseline and Week 24 and 52 | On each assessment day at Week 24 and 52, adrenal cortical function tests were performed between 8:00-10:00 in the morning. Additional measurements were taken at follow up visit, if the measurements made at Week 52 revealed any abnormalities of clinical significance. Blood samples were taken from participants at rest before undergoing spirometry. Baseline value was the measurement taken at the start of run-in or the treatment period. Change from Baseline was any post Baseline value minus value at Baseline. |
| Mean Level of Plasma Cortisol 2 | Up to Week 56 | On each assessment day at Week 24, 52 and follow up, adrenal cortical function tests were performed between 8:00-10:00 in the morning. Additional measurements were taken at follow up visit, if the measurements made at Week 52 revealed any abnormalities of clinical significance. Blood samples were taken from participants at rest before undergoing spirometry. |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline and up to Week 56 | Systolic and diastolic BP was measured in sitting position. Baseline value was the measurement taken at the start of run-in or the treatment period. Change from Baseline was any post Baseline value minus value at Baseline. |
| Mean Change From Baseline in Pulse Rate | Baseline and up to Week 56 | Pulse rate was measured in sitting position. Baseline value was the measurement taken at the start of run-in or the treatment period. Change from Baseline was any post Baseline value minus value at Baseline. |
| Number of Participants With Abnormal Oropharyngeal Examination Findings | Up to Week 56 | Oropharyngeal examination was performed in participants with suspected oral infection (candidiasis). |
| Number of Participants With Abnormal (Clinically Significant) Electrocardiogram (ECG) Findings | Up to Week 56 | On each assessment day at Week 24, 52 and follow up 12-lead ECG was performed. Additional measurements were taken at follow up visit, if the measurements made at Week 52 revealed any abnormalities of clinical significance. |
| Mean Change From Baseline in Bone Mineral Density (BMD) | Baseline and up to Week 56 | On each assessment day at Week 52 and follow up, lumber (L1-L4) BMD was determined with a BMD meter by the dual energy X-ray absorption (DEXA) method. Baseline value was the measurement taken during run-in period. Change from Baseline was any value post Baseline minus value at Baseline. |
| Mean Change From Baseline in Weight | Baseline and up to Week 56 | Body weight was measured during run-in period, at Week 24 and 52. |
| Number of Participants With Abnormal (Clinically Significant) Ophthalmological Examinations Findings | Up to Week 56 | On each assessment day at Week 24, 52 and follow up, ophthalmological examinations (vision, cornea, lens, intraocular pressure, fundus oculi) were performed to determine the presence or absence of glaucoma and cataract. |
| Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Up to Week 56 | Hematology parameters: Red blood cells (RBC), Hemoglobin (Hb), Hematocrit, Platelet count (PC), White blood cells (WBC), Basophils, Eosinophils, Neutrophils, Lymphocytes and Monocytes were presented as the outliers from the normal range as \> upper limit and \< lower limit. Only number of participants with hematology values outside normal range were presented. |
| Mean Change From Baseline in Forced Vital Capacity (FVC) | Baseline and up to Week 52 | FVC was the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. Baseline value was the value measured at visit 2. However, when the value at Visit 2 was missing, the value at Visit 1 was used as Baseline. Change from Baseline was any post Baseline value minus Baseline value. |
| Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | Baseline and up to Week 52 | V25 and V 50 were measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. Baseline value was the value measured at visit 2. However, when the value at Visit 2 was missing, the value at Visit 1 was used as baseline. Change from Baseline was any post Baseline value minus Baseline value. |
| Mean Change From Baseline in Percent of Days Without Use of Rescue Medication | Baseline and up to Week 52 | Rescue medication (salbutamol sulfate aerosol provided as an investigational product) was issued to a participant and, when necessary, a spacer at the start of the run-in period. At each time of entry in the Chronic Obstructive Pulmonary Disease (COPD) diary, a participant recorded the number of occasions of rescue medication inhaled in the previous 24 hours in the COPD diary. Baseline was mean value of the consecutive 7 days just before Visit 2. Change from Baseline was any post Baseline value minus Baseline value. |
| Change From Baseline in Symptom Score With Respect to Breathlessness, Cough, Sputum and Nighttime Awakenings | Baseline and up to Week 52 | A participant recorded scores on the scale of 0 to 4 for breathlessness and nighttime awakenings, where 0 indicated no symptoms and 4 indicated severe symptoms; on the scale of 0 to 3 for cough and sputum production, where 0 indicated no symptoms and 3 indicated severe symptoms, in the 24 hours prior to each entry in the COPD diary. Baseline was mean value of the consecutive 7 days just before Visit2. Change from Baseline was any post Baseline value minus Baseline value. |
| Mean Frequency of Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | Up to Week 56 | An exacerbation was defined as worsening of the participant's symptoms of cough, sputum production and breathlessness requiring a change in medication. When a moderate or severe COPD exacerbation was observed, details (date of onset, outcome, date of resolution/death, severity, medications provided for treatment, whether the COPD exacerbation required hospitalization, whether the COPD exacerbation required participant withdrawal from the study) were recorded. |
| Mean Observed Maximum Plasma Concentration (Cmax) of Fluticasone Propionate (FP) | Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours | For analysis of pharmacokinetic (PK) parameters for FP, blood samples were taken just before dosing (within one hour prior to dosing), 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants. |
| Mean Cmax of Salmeterol | Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours | For analysis of PK parameters for salmeterol, blood samples were taken just before dosing (within one hour prior to dosing), 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants. |
| Median Time of Observed Maximum Plasma Concentration (Tmax) of FP | Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours | For analysis of PK parameters for FP, blood samples were taken just before dosing (within one hour prior to dosing), 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants. |
| Median Tmax of Salmeterol | Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours | For analysis of PK parameters for salmeterol, blood samples were taken just before dosing (within one hour prior to dosing), 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants. |
| Mean Area Under the Plasma Concentration-time Curve Over a Dosing Interval [AUC(0-tau)] of FP | Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours | For analysis of PK parameters for FP, blood samples were taken just before dosing (within one hour prior to dosing), 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants. |
| Mean Area Under the Plasma Concentration-time Curve From Zero up to the Last Quantifiable Plasma Concentration [AUC (0-t)] of Salmeterol | Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours | For analysis of PK parameters for salmeterol, blood samples were taken just before dosing (within one hour prior to dosing), 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants. |
| Mean Change From Baseline in Peak Expiratory Flow (PEF) | Baseline and up to Week 52 | PEF was the maximum speed of expiration measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. Baseline value was the value measured at visit 2. However, when the value at Visit 2 was missing, the value at Visit 1 was used as Baseline. Change from Baseline was any post Baseline value minus Baseline value. |
Countries
Japan
Participant flow
Recruitment details
A study was conducted at 20 centers in Japan from 28 December 2004 to 25 October 2006.
Pre-assignment details
The study period consisted of 2-week run-in period (could be extended up to 4 weeks). Total 174 participants entered into the study, of which 127 participants were screened and entered into run-in phase. Five participants withdrew from the study during run-in phase and total 122 participants received study medication.
Participants by arm
| Arm | Count |
|---|---|
| GW815SF 50/500 µg Participants received one inhalation of GW815SF 50/500 µg (50 µg salmeterol and 500 µg fluticasone propionate) twice daily for 52 weeks. Participants also received Salbutamol sulfate aerosol as a rescue medication on an as-needed basis. | 122 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 20 |
| Overall Study | Exacerbation of COPD | 13 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | GW815SF 50/500 µg |
|---|---|
| Age, Continuous | 70.2 Years STANDARD_DEVIATION 6.34 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 122 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 122 |
| other Total, other adverse events | 105 / 122 |
| serious Total, serious adverse events | 27 / 122 |
Outcome results
Primary
Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)
AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Time frame: Up to Week 56
Population: Safety Population included all participants who had received an investigational product even for once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GW815SF 50/500 µg | Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs) | Any AEs | 120 Participants |
| GW815SF 50/500 µg | Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs) | Any SAEs | 27 Participants |
Secondary
Change From Baseline in Symptom Score With Respect to Breathlessness, Cough, Sputum and Nighttime Awakenings
A participant recorded scores on the scale of 0 to 4 for breathlessness and nighttime awakenings, where 0 indicated no symptoms and 4 indicated severe symptoms; on the scale of 0 to 3 for cough and sputum production, where 0 indicated no symptoms and 3 indicated severe symptoms, in the 24 hours prior to each entry in the COPD diary. Baseline was mean value of the consecutive 7 days just before Visit2. Change from Baseline was any post Baseline value minus Baseline value.
Time frame: Baseline and up to Week 52
Population: FAS Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW815SF 50/500 µg | Change From Baseline in Symptom Score With Respect to Breathlessness, Cough, Sputum and Nighttime Awakenings | Breathlessness, treatment period | -0.2 Scores on a scale | Standard Deviation 0.57 |
| GW815SF 50/500 µg | Change From Baseline in Symptom Score With Respect to Breathlessness, Cough, Sputum and Nighttime Awakenings | Cough, treatment period | 0.0 Scores on a scale | Standard Deviation 0.51 |
| GW815SF 50/500 µg | Change From Baseline in Symptom Score With Respect to Breathlessness, Cough, Sputum and Nighttime Awakenings | Sputum, treatment period | 0.0 Scores on a scale | Standard Deviation 0.5 |
| GW815SF 50/500 µg | Change From Baseline in Symptom Score With Respect to Breathlessness, Cough, Sputum and Nighttime Awakenings | Nighttime awakenings, treatment period | -0.1 Scores on a scale | Standard Deviation 0.53 |
Secondary
Mean Area Under the Plasma Concentration-time Curve From Zero up to the Last Quantifiable Plasma Concentration [AUC (0-t)] of Salmeterol
For analysis of PK parameters for salmeterol, blood samples were taken just before dosing (within one hour prior to dosing), 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants.
Time frame: Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours
Population: All evaluable subjects. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GW815SF 50/500 µg | Mean Area Under the Plasma Concentration-time Curve From Zero up to the Last Quantifiable Plasma Concentration [AUC (0-t)] of Salmeterol | 158.16 Hours*picogram per milliliter | Standard Deviation 81.987 |
Secondary
Mean Area Under the Plasma Concentration-time Curve Over a Dosing Interval [AUC(0-tau)] of FP
For analysis of PK parameters for FP, blood samples were taken just before dosing (within one hour prior to dosing), 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants.
Time frame: Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours
Population: All evaluable subjects. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GW815SF 50/500 µg | Mean Area Under the Plasma Concentration-time Curve Over a Dosing Interval [AUC(0-tau)] of FP | 903.48 Hours*picogram per milliliter | Standard Deviation 303.721 |
Secondary
Mean Change From Baseline in Bone Mineral Density (BMD)
On each assessment day at Week 52 and follow up, lumber (L1-L4) BMD was determined with a BMD meter by the dual energy X-ray absorption (DEXA) method. Baseline value was the measurement taken during run-in period. Change from Baseline was any value post Baseline minus value at Baseline.
Time frame: Baseline and up to Week 56
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GW815SF 50/500 µg | Mean Change From Baseline in Bone Mineral Density (BMD) | -0.014 Grams per centimeter square | Standard Deviation 0.0618 |
Secondary
Mean Change From Baseline in Forced Vital Capacity (FVC)
FVC was the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. Baseline value was the value measured at visit 2. However, when the value at Visit 2 was missing, the value at Visit 1 was used as Baseline. Change from Baseline was any post Baseline value minus Baseline value.
Time frame: Baseline and up to Week 52
Population: FAS Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW815SF 50/500 µg | Mean Change From Baseline in Forced Vital Capacity (FVC) | Week 4 | 0.128 Liters | Standard Deviation 0.3048 |
| GW815SF 50/500 µg | Mean Change From Baseline in Forced Vital Capacity (FVC) | Week 8 | 0.156 Liters | Standard Deviation 0.3411 |
| GW815SF 50/500 µg | Mean Change From Baseline in Forced Vital Capacity (FVC) | Week 12 | 0.142 Liters | Standard Deviation 0.3772 |
| GW815SF 50/500 µg | Mean Change From Baseline in Forced Vital Capacity (FVC) | Week 16 | 0.140 Liters | Standard Deviation 0.3199 |
| GW815SF 50/500 µg | Mean Change From Baseline in Forced Vital Capacity (FVC) | Week 20 | 0.106 Liters | Standard Deviation 0.3318 |
| GW815SF 50/500 µg | Mean Change From Baseline in Forced Vital Capacity (FVC) | Week 52/ withdrawal | 0.096 Liters | Standard Deviation 0.44 |
| GW815SF 50/500 µg | Mean Change From Baseline in Forced Vital Capacity (FVC) | Week 24 | 0.127 Liters | Standard Deviation 0.3247 |
| GW815SF 50/500 µg | Mean Change From Baseline in Forced Vital Capacity (FVC) | Week 28 | 0.149 Liters | Standard Deviation 0.4115 |
| GW815SF 50/500 µg | Mean Change From Baseline in Forced Vital Capacity (FVC) | Week 32 | 0.142 Liters | Standard Deviation 0.3587 |
| GW815SF 50/500 µg | Mean Change From Baseline in Forced Vital Capacity (FVC) | Week 36 | 0.147 Liters | Standard Deviation 0.3447 |
| GW815SF 50/500 µg | Mean Change From Baseline in Forced Vital Capacity (FVC) | Week 40 | 0.148 Liters | Standard Deviation 0.3803 |
| GW815SF 50/500 µg | Mean Change From Baseline in Forced Vital Capacity (FVC) | Week 44 | 0.156 Liters | Standard Deviation 0.3699 |
| GW815SF 50/500 µg | Mean Change From Baseline in Forced Vital Capacity (FVC) | Week 48 | 0.147 Liters | Standard Deviation 0.3713 |
| GW815SF 50/500 µg | Mean Change From Baseline in Forced Vital Capacity (FVC) | Week 52 | 0.170 Liters | Standard Deviation 0.3841 |
Secondary
Mean Change From Baseline in Level of Plasma Cortisol 1
On each assessment day at Week 24 and 52, adrenal cortical function tests were performed between 8:00-10:00 in the morning. Additional measurements were taken at follow up visit, if the measurements made at Week 52 revealed any abnormalities of clinical significance. Blood samples were taken from participants at rest before undergoing spirometry. Baseline value was the measurement taken at the start of run-in or the treatment period. Change from Baseline was any post Baseline value minus value at Baseline.
Time frame: Baseline and Week 24 and 52
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW815SF 50/500 µg | Mean Change From Baseline in Level of Plasma Cortisol 1 | Week 24 | 0.86 Micrograms per decilitre (µg/dL) | Standard Deviation 2.945 |
| GW815SF 50/500 µg | Mean Change From Baseline in Level of Plasma Cortisol 1 | Week 52/Withdrawal | -0.62 Micrograms per decilitre (µg/dL) | Standard Deviation 3.118 |
Secondary
Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity
V25 and V 50 were measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. Baseline value was the value measured at visit 2. However, when the value at Visit 2 was missing, the value at Visit 1 was used as baseline. Change from Baseline was any post Baseline value minus Baseline value.
Time frame: Baseline and up to Week 52
Population: FAS Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V25, Baseline | 0.018 Liter per second | Standard Deviation 0.0595 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V25, Week 8 | 0.021 Liter per second | Standard Deviation 0.0685 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V25, Week 28 | 0.012 Liter per second | Standard Deviation 0.0753 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V25, Week 32 | 0.009 Liter per second | Standard Deviation 0.0628 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V25, Week 36 | 0.018 Liter per second | Standard Deviation 0.0689 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V25, Week 40 | 0.022 Liter per second | Standard Deviation 0.0715 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V25, Week 44 | 0.015 Liter per second | Standard Deviation 0.0681 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V25, Week 48 | 0.010 Liter per second | Standard Deviation 0.0735 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V25, Week 52 | 0.017 Liter per second | Standard Deviation 0.0839 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V25, Week 52/ withdrawal | 0.012 Liter per second | Standard Deviation 0.0819 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V50, Week 4 | 0.044 Liter per second | Standard Deviation 0.1708 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V50, Week 8 | 0.076 Liter per second | Standard Deviation 0.1665 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V50, Week 12 | 0.054 Liter per second | Standard Deviation 0.1797 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V50, Week 16 | 0.060 Liter per second | Standard Deviation 0.1555 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V50, Week 20 | 0.040 Liter per second | Standard Deviation 0.1839 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V50, Week 24 | 0.047 Liter per second | Standard Deviation 0.1891 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V50, Week 28 | 0.049 Liter per second | Standard Deviation 0.1799 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V50, Week 32 | 0.053 Liter per second | Standard Deviation 0.1866 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V50, Week 36 | 0.046 Liter per second | Standard Deviation 0.198 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V50, Week 40 | 0.053 Liter per second | Standard Deviation 0.1953 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V50, Week 44 | 0.046 Liter per second | Standard Deviation 0.1879 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V50, Week 48 | 0.038 Liter per second | Standard Deviation 0.1807 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V50, Week 52 | 0.059 Liter per second | Standard Deviation 0.205 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V50, Week 52/ withdrawal | 0.045 Liter per second | Standard Deviation 0.2024 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V25, Week 12 | 0.015 Liter per second | Standard Deviation 0.0611 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V25, Week 16 | 0.016 Liter per second | Standard Deviation 0.0713 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V25, Week 20 | 0.012 Liter per second | Standard Deviation 0.0693 |
| GW815SF 50/500 µg | Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity | V25, Week 24 | 0.017 Liter per second | Standard Deviation 0.0649 |
Secondary
Mean Change From Baseline in Peak Expiratory Flow (PEF)
PEF was the maximum speed of expiration measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. Baseline value was the value measured at visit 2. However, when the value at Visit 2 was missing, the value at Visit 1 was used as Baseline. Change from Baseline was any post Baseline value minus Baseline value.
Time frame: Baseline and up to Week 52
Population: Full analysis set (FAS) Population included all enrolled Population excluding those who had not received investigational product at all and those who had no available data regarding efficacy after starting treatment with investigational product. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW815SF 50/500 µg | Mean Change From Baseline in Peak Expiratory Flow (PEF) | Week 28 | 0.334 Liters per second | Standard Deviation 0.7185 |
| GW815SF 50/500 µg | Mean Change From Baseline in Peak Expiratory Flow (PEF) | Week 32 | 0.269 Liters per second | Standard Deviation 0.7712 |
| GW815SF 50/500 µg | Mean Change From Baseline in Peak Expiratory Flow (PEF) | Week 36 | 0.350 Liters per second | Standard Deviation 0.7354 |
| GW815SF 50/500 µg | Mean Change From Baseline in Peak Expiratory Flow (PEF) | Week 40 | 0.277 Liters per second | Standard Deviation 0.751 |
| GW815SF 50/500 µg | Mean Change From Baseline in Peak Expiratory Flow (PEF) | Week 48 | 0.314 Liters per second | Standard Deviation 0.76 |
| GW815SF 50/500 µg | Mean Change From Baseline in Peak Expiratory Flow (PEF) | Week 52 | 0.296 Liters per second | Standard Deviation 0.7666 |
| GW815SF 50/500 µg | Mean Change From Baseline in Peak Expiratory Flow (PEF) | Week 52/ withdrawal | 0.229 Liters per second | Standard Deviation 0.7942 |
| GW815SF 50/500 µg | Mean Change From Baseline in Peak Expiratory Flow (PEF) | Week 4 | 0.315 Liters per second | Standard Deviation 0.6108 |
| GW815SF 50/500 µg | Mean Change From Baseline in Peak Expiratory Flow (PEF) | Week 8 | 0.446 Liters per second | Standard Deviation 0.6561 |
| GW815SF 50/500 µg | Mean Change From Baseline in Peak Expiratory Flow (PEF) | Week 12 | 0.394 Liters per second | Standard Deviation 0.6607 |
| GW815SF 50/500 µg | Mean Change From Baseline in Peak Expiratory Flow (PEF) | Week 16 | 0.357 Liters per second | Standard Deviation 0.6991 |
| GW815SF 50/500 µg | Mean Change From Baseline in Peak Expiratory Flow (PEF) | Week 20 | 0.309 Liters per second | Standard Deviation 0.6281 |
| GW815SF 50/500 µg | Mean Change From Baseline in Peak Expiratory Flow (PEF) | Week 24 | 0.328 Liters per second | Standard Deviation 0.6912 |
| GW815SF 50/500 µg | Mean Change From Baseline in Peak Expiratory Flow (PEF) | Week 44 | 0.307 Liters per second | Standard Deviation 0.761 |
Secondary
Mean Change From Baseline in Percent of Days Without Use of Rescue Medication
Rescue medication (salbutamol sulfate aerosol provided as an investigational product) was issued to a participant and, when necessary, a spacer at the start of the run-in period. At each time of entry in the Chronic Obstructive Pulmonary Disease (COPD) diary, a participant recorded the number of occasions of rescue medication inhaled in the previous 24 hours in the COPD diary. Baseline was mean value of the consecutive 7 days just before Visit 2. Change from Baseline was any post Baseline value minus Baseline value.
Time frame: Baseline and up to Week 52
Population: FAS Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GW815SF 50/500 µg | Mean Change From Baseline in Percent of Days Without Use of Rescue Medication | 15.6 Percentage of days | Standard Deviation 33.96 |
Secondary
Mean Change From Baseline in Pulse Rate
Pulse rate was measured in sitting position. Baseline value was the measurement taken at the start of run-in or the treatment period. Change from Baseline was any post Baseline value minus value at Baseline.
Time frame: Baseline and up to Week 56
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW815SF 50/500 µg | Mean Change From Baseline in Pulse Rate | Week 16 | 1.0 beats per min | Standard Deviation 10.03 |
| GW815SF 50/500 µg | Mean Change From Baseline in Pulse Rate | Week 20 | 1.1 beats per min | Standard Deviation 11.19 |
| GW815SF 50/500 µg | Mean Change From Baseline in Pulse Rate | Week 48 | -0.2 beats per min | Standard Deviation 10.66 |
| GW815SF 50/500 µg | Mean Change From Baseline in Pulse Rate | Week 52 / withdrawal | 0.8 beats per min | Standard Deviation 11.18 |
| GW815SF 50/500 µg | Mean Change From Baseline in Pulse Rate | Week 40 | 0.7 beats per min | Standard Deviation 10.94 |
| GW815SF 50/500 µg | Mean Change From Baseline in Pulse Rate | Week 44 | 0.4 beats per min | Standard Deviation 11 |
| GW815SF 50/500 µg | Mean Change From Baseline in Pulse Rate | Week 4 | -1.5 beats per min | Standard Deviation 11.19 |
| GW815SF 50/500 µg | Mean Change From Baseline in Pulse Rate | Week 8 | -1.6 beats per min | Standard Deviation 10.12 |
| GW815SF 50/500 µg | Mean Change From Baseline in Pulse Rate | Week 12 | -0.4 beats per min | Standard Deviation 10.4 |
| GW815SF 50/500 µg | Mean Change From Baseline in Pulse Rate | Week 24 | 1.4 beats per min | Standard Deviation 11.74 |
| GW815SF 50/500 µg | Mean Change From Baseline in Pulse Rate | Week 28 | 1.2 beats per min | Standard Deviation 10.23 |
| GW815SF 50/500 µg | Mean Change From Baseline in Pulse Rate | Week 32 | 0.4 beats per min | Standard Deviation 10.69 |
| GW815SF 50/500 µg | Mean Change From Baseline in Pulse Rate | Week 36 | 0.9 beats per min | Standard Deviation 9.76 |
Secondary
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Systolic and diastolic BP was measured in sitting position. Baseline value was the measurement taken at the start of run-in or the treatment period. Change from Baseline was any post Baseline value minus value at Baseline.
Time frame: Baseline and up to Week 56
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 4 | 0.5 Millimeter of mercury (mmHg) | Standard Deviation 14.22 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 8 | -0.1 Millimeter of mercury (mmHg) | Standard Deviation 14.74 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 12 | 0.6 Millimeter of mercury (mmHg) | Standard Deviation 15.85 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 16 | 0.7 Millimeter of mercury (mmHg) | Standard Deviation 15.98 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 44 | -3.1 Millimeter of mercury (mmHg) | Standard Deviation 17.48 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 48 | -4.1 Millimeter of mercury (mmHg) | Standard Deviation 16.23 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 52 / withdrawal | 0.3 Millimeter of mercury (mmHg) | Standard Deviation 18.12 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 16 | 0.3 Millimeter of mercury (mmHg) | Standard Deviation 10.07 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 20 | -1.4 Millimeter of mercury (mmHg) | Standard Deviation 9.91 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 24 | 0.6 Millimeter of mercury (mmHg) | Standard Deviation 9.88 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 28 | -0.6 Millimeter of mercury (mmHg) | Standard Deviation 10 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 32 | -1.4 Millimeter of mercury (mmHg) | Standard Deviation 11.35 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 36 | 0.0 Millimeter of mercury (mmHg) | Standard Deviation 10.16 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 20 | -0.8 Millimeter of mercury (mmHg) | Standard Deviation 17.08 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 24 | 0.2 Millimeter of mercury (mmHg) | Standard Deviation 16.5 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 28 | -0.4 Millimeter of mercury (mmHg) | Standard Deviation 17.1 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 32 | -1.8 Millimeter of mercury (mmHg) | Standard Deviation 17.74 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 36 | 1.1 Millimeter of mercury (mmHg) | Standard Deviation 17.67 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 40 | 0.4 Millimeter of mercury (mmHg) | Standard Deviation 17.09 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 4 | -0.7 Millimeter of mercury (mmHg) | Standard Deviation 9.22 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 8 | -1.2 Millimeter of mercury (mmHg) | Standard Deviation 9.22 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 12 | 0.3 Millimeter of mercury (mmHg) | Standard Deviation 9.72 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 40 | -1.3 Millimeter of mercury (mmHg) | Standard Deviation 10.66 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 44 | -2.1 Millimeter of mercury (mmHg) | Standard Deviation 11.01 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 48 | -2.9 Millimeter of mercury (mmHg) | Standard Deviation 9.44 |
| GW815SF 50/500 µg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 52 / withdrawal | -0.1 Millimeter of mercury (mmHg) | Standard Deviation 10.42 |
Secondary
Mean Change From Baseline in Weight
Body weight was measured during run-in period, at Week 24 and 52.
Time frame: Baseline and up to Week 56
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW815SF 50/500 µg | Mean Change From Baseline in Weight | Week 24 | 0.17 Kilograms | Standard Deviation 1.785 |
| GW815SF 50/500 µg | Mean Change From Baseline in Weight | Withdrawal | -0.51 Kilograms | Standard Deviation 2.188 |
Secondary
Mean Cmax of Salmeterol
For analysis of PK parameters for salmeterol, blood samples were taken just before dosing (within one hour prior to dosing), 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants.
Time frame: Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours
Population: All evaluable subjects. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GW815SF 50/500 µg | Mean Cmax of Salmeterol | 66.04 pg/mL | Standard Deviation 24.955 |
Secondary
Mean Frequency of Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
An exacerbation was defined as worsening of the participant's symptoms of cough, sputum production and breathlessness requiring a change in medication. When a moderate or severe COPD exacerbation was observed, details (date of onset, outcome, date of resolution/death, severity, medications provided for treatment, whether the COPD exacerbation required hospitalization, whether the COPD exacerbation required participant withdrawal from the study) were recorded.
Time frame: Up to Week 56
Population: FAS Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GW815SF 50/500 µg | Mean Frequency of Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 0.456 Number of exacerbations | Standard Deviation 1.356 |
Secondary
Mean Level of Plasma Cortisol 2
On each assessment day at Week 24, 52 and follow up, adrenal cortical function tests were performed between 8:00-10:00 in the morning. Additional measurements were taken at follow up visit, if the measurements made at Week 52 revealed any abnormalities of clinical significance. Blood samples were taken from participants at rest before undergoing spirometry.
Time frame: Up to Week 56
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GW815SF 50/500 µg | Mean Level of Plasma Cortisol 2 | Baseline | 9.41 µg/dL | Geometric Coefficient of Variation 26.69 |
| GW815SF 50/500 µg | Mean Level of Plasma Cortisol 2 | Week 24 | 10.08 µg/dL | Geometric Coefficient of Variation 34.19 |
| GW815SF 50/500 µg | Mean Level of Plasma Cortisol 2 | Week 52/Withdrawal | 8.49 µg/dL | Geometric Coefficient of Variation 38.63 |
Secondary
Mean Observed Maximum Plasma Concentration (Cmax) of Fluticasone Propionate (FP)
For analysis of pharmacokinetic (PK) parameters for FP, blood samples were taken just before dosing (within one hour prior to dosing), 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants.
Time frame: Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours
Population: All participants evaluable for pharmacokinetic parameters were included in PK Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GW815SF 50/500 µg | Mean Observed Maximum Plasma Concentration (Cmax) of Fluticasone Propionate (FP) | 124.63 Picograms per milliliter (pg/mL) | Standard Deviation 38.597 |
Secondary
Median Time of Observed Maximum Plasma Concentration (Tmax) of FP
For analysis of PK parameters for FP, blood samples were taken just before dosing (within one hour prior to dosing), 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants.
Time frame: Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours
Population: All evaluable subjects. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GW815SF 50/500 µg | Median Time of Observed Maximum Plasma Concentration (Tmax) of FP | 0.875 hours |
Secondary
Median Tmax of Salmeterol
For analysis of PK parameters for salmeterol, blood samples were taken just before dosing (within one hour prior to dosing), 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants.
Time frame: Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours
Population: All evaluable subjects. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GW815SF 50/500 µg | Median Tmax of Salmeterol | 0.250 hour |
Secondary
Number of Participants With Abnormal (Clinically Significant) Electrocardiogram (ECG) Findings
On each assessment day at Week 24, 52 and follow up 12-lead ECG was performed. Additional measurements were taken at follow up visit, if the measurements made at Week 52 revealed any abnormalities of clinical significance.
Time frame: Up to Week 56
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GW815SF 50/500 µg | Number of Participants With Abnormal (Clinically Significant) Electrocardiogram (ECG) Findings | Baseline | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Clinically Significant) Electrocardiogram (ECG) Findings | Week 24 | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Clinically Significant) Electrocardiogram (ECG) Findings | Withdrawal | 4 Participants |
Secondary
Number of Participants With Abnormal (Clinically Significant) Ophthalmological Examinations Findings
On each assessment day at Week 24, 52 and follow up, ophthalmological examinations (vision, cornea, lens, intraocular pressure, fundus oculi) were performed to determine the presence or absence of glaucoma and cataract.
Time frame: Up to Week 56
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GW815SF 50/500 µg | Number of Participants With Abnormal (Clinically Significant) Ophthalmological Examinations Findings | Cataract, Baseline | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Clinically Significant) Ophthalmological Examinations Findings | Cataract, Week 24 | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Clinically Significant) Ophthalmological Examinations Findings | Cataract, Withdrawal | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Clinically Significant) Ophthalmological Examinations Findings | Glaucoma, Baseline | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Clinically Significant) Ophthalmological Examinations Findings | Glucoma, Week 24 | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Clinically Significant) Ophthalmological Examinations Findings | Glucoma, Withdrawal | 4 Participants |
Secondary
Number of Participants With Abnormal Oropharyngeal Examination Findings
Oropharyngeal examination was performed in participants with suspected oral infection (candidiasis).
Time frame: Up to Week 56
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GW815SF 50/500 µg | Number of Participants With Abnormal Oropharyngeal Examination Findings | Week 36 | 7 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal Oropharyngeal Examination Findings | Week 40 | 7 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal Oropharyngeal Examination Findings | Week 44 | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal Oropharyngeal Examination Findings | Week 48 | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal Oropharyngeal Examination Findings | Week52 / withdrawal | 8 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal Oropharyngeal Examination Findings | Week -2 | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal Oropharyngeal Examination Findings | Week 0 | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal Oropharyngeal Examination Findings | Week 4 | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal Oropharyngeal Examination Findings | Week 8 | 7 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal Oropharyngeal Examination Findings | Week 12 | 7 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal Oropharyngeal Examination Findings | Week 16 | 9 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal Oropharyngeal Examination Findings | Week 20 | 9 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal Oropharyngeal Examination Findings | Week 24 | 9 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal Oropharyngeal Examination Findings | Week 28 | 6 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal Oropharyngeal Examination Findings | Week 32 | 7 Participants |
Secondary
Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters
Clinical chemistry parameters: Total bilirubin (TB), Alkaline phosphatase (Al-P), Alanine aminotransferase (ALT), Asparate aminotransferase (AST), Gamma-glutamyl transpeptidase (GTP), Lactate dehydrogenase (LDH), Total cholesterol (TC), Glucose, Creatinine, Blood urea nitrogen (BUN), Uric acid (UA), Sodium (Na), Potassium (K), Chloride (Cl) and Calcium (Ca) were presented as the outliers from the normal range as \> upper limit and \< lower limit. Only number of participants with clinical chemistry values outside normal range were presented.
Time frame: Up to Week 56
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TB, Week 24, > upper limit | 5 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TB, Week 36, > upper limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TB, Week 36, < lower limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TB, Week 52/ withdrawal, > upper limit | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | AL-P, Baseline, > upper limit | 18 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | AL-P, Week 4, > upper limit | 15 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | AL-P, Week 12, > upper limit | 15 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | AL-P, Week 24, > upper limit | 18 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | AL-P, Week 24, < lower limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | AL-P, Week 36, > upper limit | 12 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | AL-P, Week 52/ withdrawal, > upper limit | 13 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | ALT, Baseline, > upper limit | 5 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | ALT, Week 4, > upper limit | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | ALT, Week 12, > upper limit | 7 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | ALT, Week 24, > upper limit | 6 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | ALT, Week 36, > upper limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | AST, Week 4, > upper limit | 6 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Gamma GTP, Week 12, < lower limit | 8 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Gamma GTP, Week 24, > upper limit | 12 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Gamma GTP, Week 24, < lower limit | 8 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Gamma GTP, Week 36, < lower limit | 8 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Gamma GTP,Week 52/withdrawal, > upper limit | 15 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Gamma GTP,Week 52/withdrawal, < lower limit | 10 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | LDH, Baseline, > upper limit | 10 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TC, Week 12, < lower limit | 8 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TC, Week 36, > upper limit | 22 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TC, Week 36, < lower limit | 10 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TC, Week 52/ withdrawal, > upper limit | 27 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TC, Week 52/ withdrawal, < lower limit | 10 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Glucose, Baseline, > upper limit | 40 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Glucose, Week 24, > upper limit | 31 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Glucose, Week 52/ withdrawal, > upper limit | 45 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Glucose, Week 52/ withdrawal, < lower limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Creatinine, Baseline, > upper limit | 8 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Creatinine, Week 12, < lower limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Creatinine, Week 24, > upper limit | 9 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Creatinine, Week 24, < lower limit | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Creatinine, Week 36, > upper limit | 9 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Creatinine, Week 36, < lower limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Creatinine,Week 52/withdrawal, >upper limit | 7 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | BUN, Week 4, < lower limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | BUN, Week 12, > upper limit | 23 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | BUN, Week 12, < lower limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | BUN, Week 36, > upper limit | 21 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | BUN, Week 52/ withdrawal, > upper limit | 22 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | BUN, Week 52/ withdrawal, < lower limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | UA, Baseline, > upper limit | 35 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | UA, Week 52/ withdrawal, > upper limit | 32 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Na, Baseline, > upper limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Na, Week 4, > upper limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Na, Week 4, < lower limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Na, Week 12, > upper limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Na, Week 24, > upper limit | 6 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Na, Week 52/ withdrawal, < lower limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | K, Baseline, > upper limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | K, Baseline, < lower limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | K, Week 4, > upper limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | K, Week 12, < lower limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | K, Week 24, > upper limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | K, Week 24, < lower limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | K, Week 36, > upper limit | 7 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | K, Week 52/ withdrawal, > upper limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | K, Week 52/ withdrawal, < lower limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Cl, Week 12, > upper limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Cl, Week 36, > upper limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Cl, Week 52/ withdrawal, > upper limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Cl, Week 52/ withdrawal, < lower limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Ca, Baseline, > upper limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Ca, Baseline, < lower limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Ca, Week 4, > upper limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Ca, Week 4, < lower limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Ca, Week 12, > upper limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Ca, Week 12, < lower limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Ca, Week 24, > upper limit | 7 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Ca, Week 36, > upper limit | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Ca, Week 52/ withdrawal, > upper limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Ca, Week 52/ withdrawal, < lower limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TB, Baseline, > upper limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TB, Week 4, > upper limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TB, Week 12, > upper limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TB, Week 12, < lower limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | ALT, Week 52/ withdrawal, > upper limit | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | AST, Baseline, > upper limit | 9 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | AST, Week 12, > upper limit | 6 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | AST, Week 24, > upper limit | 9 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | AST, Week 36, > upper limit | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | AST, Week 52/ withdrawal, > upper limit | 5 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Gamma GTP, Baseline, > upper limit | 15 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Gamma GTP, Baseline, < lower limit | 9 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Gamma GTP, Week 4, > upper limit | 17 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Gamma GTP, Week 4, < lower limit | 10 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Gamma GTP, Week 12, > upper limit | 14 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Gamma GTP, Week 36, > upper limit | 12 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | LDH, Week 4, > upper limit | 11 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | LDH, Week 12, > upper limit | 8 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | LDH, Week 24, > upper limit | 14 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | LDH, Week 36, > upper limit | 10 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | LDH, Week 36, < lower limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | LDH, Week 52/ withdrawal, > upper limit | 9 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TC, Baseline, > upper limit | 17 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TC, Baseline, < lower limit | 13 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TC, Week 4, > upper limit | 19 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TC, Week 4, < lower limit | 16 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TC, Week 12, > upper limit | 21 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TC, Week 24, > upper limit | 20 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | TC, Week 24, < lower limit | 10 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Glucose, Baseline, < lower limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Glucose, Week 4, > upper limit | 42 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Glucose, Week 4, < lower limit | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Glucose, Week 12, > upper limit | 42 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Glucose, Week 12, < lower limit | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Glucose, Week 24, < lower limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Glucose, Week 36, > upper limit | 34 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Glucose, Week 36, < lower limit | 5 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Creatinine, Baseline, < lower limit | 8 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Creatinine, Week 4, > upper limit | 9 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Creatinine, Week 4, < lower limit | 8 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Creatinine, Week 12, > upper limit | 8 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Creatinine,Week 52/withdrawal, <lower limit | 6 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | BUN, Baseline, > upper limit | 31 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | BUN, Baseline, < lower limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | BUN, Week 4, > upper limit | 16 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | BUN, Week 24, > upper limit | 18 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | UA, Week 4, > upper limit | 31 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | UA, Week 12, > upper limit | 29 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | UA, Week 24, > upper limit | 19 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | UA, Week 36, > upper limit | 21 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Na, Week 36, > upper limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | K, Week 12, > upper limit | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Cl, Baseline, > upper limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Cl, Baseline, < lower limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Cl, Week 4, > upper limit | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Cl, Week 4, < lower limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Cl, Week 12, < lower limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Cl, Week 24, > upper limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters | Cl, Week 24, < lower limit | 2 Participants |
Secondary
Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters
Hematology parameters: Red blood cells (RBC), Hemoglobin (Hb), Hematocrit, Platelet count (PC), White blood cells (WBC), Basophils, Eosinophils, Neutrophils, Lymphocytes and Monocytes were presented as the outliers from the normal range as \> upper limit and \< lower limit. Only number of participants with hematology values outside normal range were presented.
Time frame: Up to Week 56
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | RBC, Week 36, > upper limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | RBC, Week 36, < lower limit | 22 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | RBC, Week 52/Withdrawal, > upper limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Hb, Baseline, < lower limit | 15 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Hb, Week 4, < lower limit | 20 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Hb, Week 12, < lower limit | 20 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Hb, Week 24, < lower limit | 13 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Hb, Week 36, < lower limit | 14 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Hb, Week 52/Withdrawal, <lower limit | 27 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Hematocrit, Baseline, > upper limit | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Hematocrit, Week 12, < lower limit | 13 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Hematocrit,Week 52/Withdrawal,< lower limit | 17 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | PC, Baseline, > upper limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | PC, Baseline, < lower limit | 8 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | PC, Week 4, > upper limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | PC, Week 4, < lower limit | 7 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | PC, Week 12, > upper limit | 7 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | PC, Week 12, < lower limit | 6 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | PC, Week 52/Withdrawal, < lower limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | WBC, Week 36, > upper limit | 5 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | WBC, Week 36, < lower limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | WBC, Week 52/Withdrawal, > upper limit | 7 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Basophils, Baseline, > upper limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Basophils, Week 4, > upper limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Eosinophils, Baseline, > upper limit | 17 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Eosinophils, Week 4, > upper limit | 10 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Eosinophils,Week 52/Withdrawal,> upper limit | 10 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Neutrophils, Baseline, > upper limit | 5 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Neutrophils, Baseline, < lower limit | 5 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Neutrophils, Week 4, > upper limit | 7 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Neutrophils, Week 4, < lower limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Neutrophils, Week 12, > upper limit | 6 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Neutrophils, Week 24, > upper limit | 15 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Neutrophils, Week 36, > upper limit | 9 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Neutrophils, Week 36, < lower limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Neutrophils,Week 52/Withdrawal,>upper limit | 11 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Neutrophils,Week 52/Withdrawal,< lower limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Lymphocytes, Baseline, > upper limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Lymphocytes, Baseline, < lower limit | 10 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Lymphocytes, Week 4, < lower limit | 16 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Lymphocytes, Week 12, < lower limit | 17 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Lymphocytes, Week 24, < lower limit | 25 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Monocytes, Week 4, > upper limit | 47 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Monocytes, Week 12, > upper limit | 37 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Monocytes, Week 24, > upper limit | 25 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Monocytes, Week 36, > upper limit | 28 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Monocytes, wEEK 52/Withdrawal,> upper limit | 14 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | RBC, Baseline, < lower limit | 30 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | RBC, Week 4, < lower limit | 36 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | RBC, Week 12, < lower limit | 36 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | RBC, Week 24, > upper limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | RBC, Week 24, < lower limit | 21 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | RBC, Week 52/Withdrawal, < lower limit | 33 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Hb, Baseline, > upper limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Hematocrit, Baseline, < lower limit | 10 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Hematocrit, Week 4, > upper limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Hematocrit, Week 4, < lower limit | 13 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Hematocrit, Week 12, > upper limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Hematocrit, Week 24, > upper limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Hematocrit, Week 24, < lower limit | 9 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Hematocrit, Week 36, < lower limit | 12 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | PC, Week 24, > upper limit | 5 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | PC, Week 24, < lower limit | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | PC, Week 36, > upper limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | PC, Week 36, < lower limit | 6 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | PC, Week 52/Withdrawal, > upper limit | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | WBC, Baseline, > upper limit | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | WBC, Baseline, < lower limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | WBC, Week 4, > upper limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | WBC, Week 4, < lower limit | 3 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | WBC, Week 12, > upper limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | WBC, Week 24, > upper limit | 5 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | WBC, Week 24, < lower limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Basophils, Week 12, > upper limit | 4 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Basophils, Week 36, > upper limit | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Basophils, Week 52/Withdrawal, > upper limit | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Eosinophils, Week 12, > upper limit | 10 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Eosinophils, Week 24, > upper limit | 8 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Eosinophils, Week 36, > upper limit | 8 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Lymphocytes, Week 36, < lower limit | 16 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Lymphocytes,Week 52/Withdrawal,< lower limit | 19 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters | Monocytes, Baseline, > upper limit | 31 Participants |
Secondary
Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters
Urinalysis parameters: Urine protein, Glucose and Urobilinogen were presented as shift from Baseline. Only number of participants with urinalysis values more than Baseline values were presented. The plus sign increases with a higher level of glucose and proteins in the urine: 1+: slightly positive, 2+: positive, 3+: high positive and 4+: strongly positive.
Time frame: Up to Week 56
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Urine protein, Week 4, 1+ to 3+ | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Glucose, Week 4, 3+ to 4+ | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Urine protein, Week 12, 1+ to 2+ | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Urine protein, Week 12, 1+ to 3+ | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Glucose, Week 12, 2+ to 4+ | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Glucose, Week 12, 3+ to 4+ | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Urine protein, Week 24, 1+ to 2+ | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Urine protein, Week 24, 1+ to 3+ | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Glucose, Week 24, 1+ to 2+ | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Glucose, Week 24, 1+ to 4+ | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Glucose, Week 24, 2+ to 4+ | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Urine protein, Week 36, 1+ to 2+ | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Urine protein, Week 36, 1+ to 3+ | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Glucose, Week 52/withdrawal, 2+ to 4+ | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Glucose, Week 36, 1+ to 4+ | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Glucose, Week 36, 2+ to 4+ | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Glucose, Week 36, 3+ to 4+ | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Urine protein, Week 52/withdrawal, 1+ to 3+ | 1 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Glucose, Week 52/withdrawal, 1+ to 2+ | 2 Participants |
| GW815SF 50/500 µg | Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters | Glucose, Week 52/withdrawal, 1+ to 4+ | 1 Participants |