Trial Outcomes & Findings for A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Low-Dose ICS Therapy. (NCT NCT00603278)
NCT ID: NCT00603278
Last Updated: 2016-12-28
Results Overview
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
622 participants
Primary outcome timeframe
Baseline and Week 8
Results posted on
2016-12-28
Participant Flow
Participants (par.) meeting eligibility criteria at the Screening visit completed a 28-day Run-in Period for Baseline safety evaluations and measures of asthma status. Par. were then randomized to an 8-week Treatment Period. 1406 par. were screened, and 622 par. were randomized, out of which 615 par. received at least one dose of study treatment.
Participant milestones
| Measure |
Placebo
Participants received placebo once daily (OD) in the evening from the novel dry powder inhaler (NDPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
Participants received GW685698X 100 micrograms (µg) OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
107
|
105
|
101
|
103
|
99
|
100
|
|
Overall Study
COMPLETED
|
66
|
88
|
87
|
92
|
86
|
81
|
|
Overall Study
NOT COMPLETED
|
41
|
17
|
14
|
11
|
13
|
19
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo once daily (OD) in the evening from the novel dry powder inhaler (NDPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
Participants received GW685698X 100 micrograms (µg) OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
35
|
10
|
11
|
8
|
7
|
14
|
|
Overall Study
Adverse Event
|
0
|
3
|
1
|
0
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
1
|
2
|
1
|
2
|
|
Overall Study
Protocol Violation
|
3
|
0
|
1
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Low-Dose ICS Therapy.
Baseline characteristics by cohort
| Measure |
Placebo
n=107 Participants
Participants received placebo once daily OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=105 Participants
Participants received GW685698X 100 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=101 Participants
Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=103 Participants
Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=99 Participants
Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=100 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
Total
n=615 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.1 Years
STANDARD_DEVIATION 16.19 • n=5 Participants
|
38.3 Years
STANDARD_DEVIATION 16.76 • n=7 Participants
|
38.8 Years
STANDARD_DEVIATION 15.97 • n=5 Participants
|
39.9 Years
STANDARD_DEVIATION 15.57 • n=4 Participants
|
40.7 Years
STANDARD_DEVIATION 15.87 • n=21 Participants
|
39.8 Years
STANDARD_DEVIATION 16.70 • n=8 Participants
|
39.4 Years
STANDARD_DEVIATION 16.14 • n=8 Participants
|
|
Gender
Female
|
74 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
62 Participants
n=8 Participants
|
402 Participants
n=8 Participants
|
|
Gender
Male
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
38 Participants
n=8 Participants
|
213 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
62 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
61 Participants
n=8 Participants
|
371 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Central/South Asian Heritage (HER)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Japanese/East Asian HER/South East Asian HER
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
142 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native & White
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
79 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
African American/African HER
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage & White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement (scheduled and unscheduled visits) was used to impute missing measurements.
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.
Outcome measures
| Measure |
Placebo
n=106 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=102 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=101 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=102 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=97 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=99 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8
|
-0.065 Liters
Standard Error 0.0395
|
0.142 Liters
Standard Error 0.0403
|
0.173 Liters
Standard Error 0.0404
|
0.228 Liters
Standard Error 0.0402
|
0.215 Liters
Standard Error 0.0414
|
0.160 Liters
Standard Error 0.0409
|
SECONDARY outcome
Timeframe: From Baseline up to Week 8Population: ITT Population. Only those participants available at the specified time points were analyzed.
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=104 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=101 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=102 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=99 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=99 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period
|
-2.8 Liters per minute
Standard Error 3.54
|
9.1 Liters per minute
Standard Error 3.60
|
14.8 Liters per minute
Standard Error 3.65
|
15.1 Liters per minute
Standard Error 3.62
|
21.0 Liters per minute
Standard Error 3.70
|
18.2 Liters per minute
Standard Error 3.69
|
SECONDARY outcome
Timeframe: From Baseline up to Week 8Population: ITT Population. Only those participants available at the specified time points were analyzed.
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=104 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=101 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=102 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=99 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=99 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period
|
-4.7 Liters per minute
Standard Error 3.78
|
15.6 Liters per minute
Standard Error 3.85
|
16.0 Liters per minute
Standard Error 3.89
|
25.5 Liters per minute
Standard Error 3.87
|
26.0 Liters per minute
Standard Error 3.95
|
25.1 Liters per minute
Standard Error 3.94
|
SECONDARY outcome
Timeframe: From Baseline up to Week 8Population: ITT Population. Only those participants available at the specified time points were analyzed.
Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=104 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=101 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=102 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=99 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=99 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period
|
17.1 Percentage of symptom-free 24-hr periods
Standard Error 2.91
|
21.3 Percentage of symptom-free 24-hr periods
Standard Error 2.96
|
19.4 Percentage of symptom-free 24-hr periods
Standard Error 2.99
|
24.1 Percentage of symptom-free 24-hr periods
Standard Error 2.97
|
28.0 Percentage of symptom-free 24-hr periods
Standard Error 3.02
|
30.4 Percentage of symptom-free 24-hr periods
Standard Error 3.02
|
SECONDARY outcome
Timeframe: From Baseline up to Week 8Population: ITT Population. Only those participants available at the specified time points were analyzed.
The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hr period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of baseline, country, sex, age, and treatment group.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=104 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=101 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=102 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=99 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=99 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period
|
15.6 Percentage of rescue-free 24-hr periods
Standard Error 3.02
|
25.0 Percentage of rescue-free 24-hr periods
Standard Error 3.07
|
23.8 Percentage of rescue-free 24-hr periods
Standard Error 3.12
|
25.0 Percentage of rescue-free 24-hr periods
Standard Error 3.10
|
24.4 Percentage of rescue-free 24-hr periods
Standard Error 3.15
|
34.5 Percentage of rescue-free 24-hr periods
Standard Error 3.15
|
SECONDARY outcome
Timeframe: From the first dose of study medication up to Week 8/Early WithdrawalPopulation: ITT Population
The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=105 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=101 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=103 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=99 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=100 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period
|
35 Participants
|
10 Participants
|
11 Participants
|
8 Participants
|
7 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study medication up to Week 8/Early WithdrawalPopulation: ITT Population
An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold \>=3%) and SAEs.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=105 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=101 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=103 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=99 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=100 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period
Any AE
|
32 Participants
|
43 Participants
|
33 Participants
|
41 Participants
|
35 Participants
|
42 Participants
|
|
Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to Week 8/Early WithdrawalPopulation: ITT Population
A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed for the entire Treatment Period.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=105 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=101 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=103 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=99 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=100 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis
Clinical evidence
|
0 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis
No clinical evidence
|
107 Participants
|
102 Participants
|
99 Participants
|
99 Participants
|
97 Participants
|
96 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: ITT Population. Only those participants available at the specified time points were analyzed.
Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Outcome measures
| Measure |
Placebo
n=100 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=103 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=97 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=99 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=94 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=95 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8
Basophils, BL, n=100, 103, 97, 99, 94, 95
|
0.33 Percentage
Standard Deviation 0.159
|
0.32 Percentage
Standard Deviation 0.179
|
0.35 Percentage
Standard Deviation 0.188
|
0.31 Percentage
Standard Deviation 0.155
|
0.33 Percentage
Standard Deviation 0.169
|
0.34 Percentage
Standard Deviation 0.209
|
|
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8
Basophils,W8, n=63, 84, 82, 83, 81, 82
|
0.31 Percentage
Standard Deviation 0.182
|
0.32 Percentage
Standard Deviation 0.191
|
0.38 Percentage
Standard Deviation 0.227
|
0.33 Percentage
Standard Deviation 0.165
|
0.32 Percentage
Standard Deviation 0.203
|
0.35 Percentage
Standard Deviation 0.190
|
|
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8
Eosinophils, BL, n=100, 103, 97, 99, 94, 95
|
4.48 Percentage
Standard Deviation 3.262
|
4.05 Percentage
Standard Deviation 2.882
|
4.05 Percentage
Standard Deviation 2.981
|
4.17 Percentage
Standard Deviation 2.649
|
4.20 Percentage
Standard Deviation 3.185
|
4.66 Percentage
Standard Deviation 3.393
|
|
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8
Eosinophils, W8, n=63, 84, 82, 83, 81, 82
|
4.78 Percentage
Standard Deviation 4.107
|
3.72 Percentage
Standard Deviation 2.518
|
3.54 Percentage
Standard Deviation 2.556
|
3.53 Percentage
Standard Deviation 2.671
|
3.35 Percentage
Standard Deviation 3.063
|
4.21 Percentage
Standard Deviation 3.290
|
|
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8
Lymphocytes, BL, n=100, 103, 97, 99, 94, 95
|
34.05 Percentage
Standard Deviation 9.683
|
33.97 Percentage
Standard Deviation 8.817
|
34.01 Percentage
Standard Deviation 9.214
|
33.70 Percentage
Standard Deviation 8.380
|
31.48 Percentage
Standard Deviation 9.075
|
33.61 Percentage
Standard Deviation 9.032
|
|
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8
Lymphocytes, W8, n=63, 84, 82, 83, 81, 82
|
33.51 Percentage
Standard Deviation 8.261
|
32.95 Percentage
Standard Deviation 8.183
|
31.39 Percentage
Standard Deviation 8.668
|
30.97 Percentage
Standard Deviation 8.711
|
27.38 Percentage
Standard Deviation 7.585
|
33.17 Percentage
Standard Deviation 7.607
|
|
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8
Monocytes, BL, n=100, 103, 97, 99, 94, 95
|
4.66 Percentage
Standard Deviation 1.674
|
4.52 Percentage
Standard Deviation 2.128
|
4.85 Percentage
Standard Deviation 1.939
|
4.58 Percentage
Standard Deviation 1.994
|
4.47 Percentage
Standard Deviation 1.954
|
4.55 Percentage
Standard Deviation 2.190
|
|
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8
Monocytes, W8, n=63, 84, 82, 83, 81, 82
|
4.85 Percentage
Standard Deviation 1.798
|
4.82 Percentage
Standard Deviation 3.006
|
4.92 Percentage
Standard Deviation 2.324
|
4.42 Percentage
Standard Deviation 1.833
|
4.18 Percentage
Standard Deviation 2.176
|
4.59 Percentage
Standard Deviation 2.436
|
|
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8
Total Neutrophils, BL, n=100, 103, 97, 99, 94, 95
|
56.53 Percentage
Standard Deviation 9.391
|
58.17 Percentage
Standard Deviation 9.386
|
59.75 Percentage
Standard Deviation 9.513
|
60.72 Percentage
Standard Deviation 9.846
|
64.75 Percentage
Standard Deviation 8.896
|
57.61 Percentage
Standard Deviation 9.681
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: ITT Population. Only those participants available at the specified time points were analyzed.
Blood samples were collected for the measurement of Hematocrit at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Outcome measures
| Measure |
Placebo
n=102 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=104 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=96 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=99 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=93 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=95 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Hematocrit at Baseline and Week 8
Hematocrit, BL, n=102, 104, 96, 99, 93, 95
|
0.42 Proportion of 1
Standard Deviation 0.041
|
0.43 Proportion of 1
Standard Deviation 0.034
|
0.42 Proportion of 1
Standard Deviation 0.043
|
0.42 Proportion of 1
Standard Deviation 0.035
|
0.42 Proportion of 1
Standard Deviation 0.039
|
0.42 Proportion of 1
Standard Deviation 0.039
|
|
Hematocrit at Baseline and Week 8
Hematocrit, W8, n=62, 84, 82, 83, 81, 81
|
0.41 Proportion of 1
Standard Deviation 0.037
|
0.42 Proportion of 1
Standard Deviation 0.039
|
0.42 Proportion of 1
Standard Deviation 0.043
|
0.41 Proportion of 1
Standard Deviation 0.038
|
0.42 Proportion of 1
Standard Deviation 0.046
|
0.41 Proportion of 1
Standard Deviation 0.055
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: ITT Population. Only those participants available at the specified time points were analyzed.
Blood samples were collected for the measurement of hemoglobin at Baseline (BL)and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Outcome measures
| Measure |
Placebo
n=102 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=104 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=96 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=99 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=93 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=95 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Hemoglobin at Baseline and Week 8
Hemoglobin, BL, n=102, 104, 96, 99, 93, 95
|
137.64 Grams per liter (G/L)
Standard Deviation 13.911
|
139.34 Grams per liter (G/L)
Standard Deviation 11.908
|
137.74 Grams per liter (G/L)
Standard Deviation 14.028
|
138.08 Grams per liter (G/L)
Standard Deviation 11.707
|
138.57 Grams per liter (G/L)
Standard Deviation 13.393
|
136.93 Grams per liter (G/L)
Standard Deviation 14.139
|
|
Hemoglobin at Baseline and Week 8
Hemoglobin, W8, n=62, 84, 82, 83, 81, 81
|
135.09 Grams per liter (G/L)
Standard Deviation 12.043
|
136.42 Grams per liter (G/L)
Standard Deviation 13.342
|
137.85 Grams per liter (G/L)
Standard Deviation 13.772
|
135.30 Grams per liter (G/L)
Standard Deviation 12.360
|
138.17 Grams per liter (G/L)
Standard Deviation 15.050
|
135.79 Grams per liter (G/L)
Standard Deviation 18.663
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: ITT Population. Only those participants available at the specified time points were analyzed.
Blood samples were collected for the measurement of platelet count and WBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Outcome measures
| Measure |
Placebo
n=101 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=103 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=96 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=99 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=93 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=95 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8
Platelet count, BL, n=98, 103,93, 98, 89, 94
|
286.23 10^9 cells per liter (GI/L)
Standard Deviation 57.383
|
277.29 10^9 cells per liter (GI/L)
Standard Deviation 64.358
|
290.90 10^9 cells per liter (GI/L)
Standard Deviation 98.801
|
282.86 10^9 cells per liter (GI/L)
Standard Deviation 70.086
|
283.01 10^9 cells per liter (GI/L)
Standard Deviation 58.915
|
285.45 10^9 cells per liter (GI/L)
Standard Deviation 69.220
|
|
Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8
Platelet count, W8, n=60, 84, 80, 81, 80, 80
|
275.91 10^9 cells per liter (GI/L)
Standard Deviation 53.705
|
281.40 10^9 cells per liter (GI/L)
Standard Deviation 66.449
|
277.73 10^9 cells per liter (GI/L)
Standard Deviation 71.595
|
287.98 10^9 cells per liter (GI/L)
Standard Deviation 67.053
|
297.83 10^9 cells per liter (GI/L)
Standard Deviation 76.271
|
287.60 10^9 cells per liter (GI/L)
Standard Deviation 87.009
|
|
Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8
WBC, BL, n=101, 103, 96, 99, 93, 95
|
8.05 10^9 cells per liter (GI/L)
Standard Deviation 2.310
|
7.90 10^9 cells per liter (GI/L)
Standard Deviation 2.110
|
7.69 10^9 cells per liter (GI/L)
Standard Deviation 2.086
|
8.11 10^9 cells per liter (GI/L)
Standard Deviation 2.332
|
8.23 10^9 cells per liter (GI/L)
Standard Deviation 2.027
|
8.12 10^9 cells per liter (GI/L)
Standard Deviation 2.141
|
|
Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8
WBC, W8, n=62, 84, 82, 83, 81, 81
|
8.02 10^9 cells per liter (GI/L)
Standard Deviation 1.991
|
8.06 10^9 cells per liter (GI/L)
Standard Deviation 1.894
|
7.79 10^9 cells per liter (GI/L)
Standard Deviation 2.066
|
8.20 10^9 cells per liter (GI/L)
Standard Deviation 1.936
|
9.07 10^9 cells per liter (GI/L)
Standard Deviation 2.054
|
8.30 10^9 cells per liter (GI/L)
Standard Deviation 3.119
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: ITT Population. Only those participants available at the specified time points were analyzed.
Blood samples were collected for the measurement of RBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Outcome measures
| Measure |
Placebo
n=102 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=104 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=96 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=99 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=93 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=95 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Red Blood Cells (RBC) Count at Baseline and Week 8
BL, n=102, 104, 96, 99, 93, 95
|
4.66 10^12 cells per liter (TI/L)
Standard Deviation 0.439
|
4.68 10^12 cells per liter (TI/L)
Standard Deviation 0.385
|
4.69 10^12 cells per liter (TI/L)
Standard Deviation 0.539
|
4.63 10^12 cells per liter (TI/L)
Standard Deviation 0.442
|
4.64 10^12 cells per liter (TI/L)
Standard Deviation 0.395
|
4.61 10^12 cells per liter (TI/L)
Standard Deviation 0.412
|
|
Red Blood Cells (RBC) Count at Baseline and Week 8
W8, n=62, 84, 82, 83, 81, 80
|
4.54 10^12 cells per liter (TI/L)
Standard Deviation 0.483
|
4.57 10^12 cells per liter (TI/L)
Standard Deviation 0.447
|
4.62 10^12 cells per liter (TI/L)
Standard Deviation 0.513
|
4.50 10^12 cells per liter (TI/L)
Standard Deviation 0.458
|
4.66 10^12 cells per liter (TI/L)
Standard Deviation 0.526
|
4.52 10^12 cells per liter (TI/L)
Standard Deviation 0.426
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: ITT Population. Only those participants available at the specified time points were analyzed.
Blood samples were collected for the measurement of ALP, ALT, AST, LD and GGT at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).
Outcome measures
| Measure |
Placebo
n=106 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=104 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=101 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=102 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=98 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=99 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8
AST, W8, n=65, 85, 85, 89, 83, 81
|
21.8 International units per liter (IU/L)
Standard Deviation 8.77
|
20.5 International units per liter (IU/L)
Standard Deviation 7.50
|
21.4 International units per liter (IU/L)
Standard Deviation 8.42
|
22.7 International units per liter (IU/L)
Standard Deviation 12.58
|
21.7 International units per liter (IU/L)
Standard Deviation 8.87
|
21.4 International units per liter (IU/L)
Standard Deviation 8.51
|
|
Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8
LD, BL, n=106, 103, 100, 102, 97, 99
|
173.2 International units per liter (IU/L)
Standard Deviation 66.73
|
167.1 International units per liter (IU/L)
Standard Deviation 44.88
|
173.8 International units per liter (IU/L)
Standard Deviation 129.22
|
169.0 International units per liter (IU/L)
Standard Deviation 54.06
|
168.6 International units per liter (IU/L)
Standard Deviation 50.65
|
167.1 International units per liter (IU/L)
Standard Deviation 57.95
|
|
Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8
LD, W8, n=65, 85, 85, 89, 83, 81
|
157.4 International units per liter (IU/L)
Standard Deviation 37.93
|
158.2 International units per liter (IU/L)
Standard Deviation 29.31
|
162.5 International units per liter (IU/L)
Standard Deviation 35.17
|
160.6 International units per liter (IU/L)
Standard Deviation 30.45
|
169.2 International units per liter (IU/L)
Standard Deviation 31.91
|
162.4 International units per liter (IU/L)
Standard Deviation 35.39
|
|
Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8
GGT, BL, n=106, 104, 101, 102, 98, 99
|
33.1 International units per liter (IU/L)
Standard Deviation 54.48
|
26.0 International units per liter (IU/L)
Standard Deviation 20.33
|
27.6 International units per liter (IU/L)
Standard Deviation 21.53
|
35.2 International units per liter (IU/L)
Standard Deviation 38.16
|
28.2 International units per liter (IU/L)
Standard Deviation 18.36
|
29.5 International units per liter (IU/L)
Standard Deviation 27.60
|
|
Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8
GGT, W8, n=65, 85, 85, 89, 83, 81
|
31.5 International units per liter (IU/L)
Standard Deviation 44.86
|
30.1 International units per liter (IU/L)
Standard Deviation 41.05
|
29.2 International units per liter (IU/L)
Standard Deviation 31.63
|
34.8 International units per liter (IU/L)
Standard Deviation 39.40
|
28.3 International units per liter (IU/L)
Standard Deviation 23.69
|
28.4 International units per liter (IU/L)
Standard Deviation 24.14
|
|
Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8
ALP, BL, n=106, 104, 101, 102, 98, 99
|
89.3 International units per liter (IU/L)
Standard Deviation 58.42
|
90.5 International units per liter (IU/L)
Standard Deviation 61.69
|
83.7 International units per liter (IU/L)
Standard Deviation 56.68
|
88.0 International units per liter (IU/L)
Standard Deviation 74.76
|
83.8 International units per liter (IU/L)
Standard Deviation 40.51
|
89.0 International units per liter (IU/L)
Standard Deviation 57.83
|
|
Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8
ALP, W8, n=65, 85, 84, 89, 83, 81
|
88.0 International units per liter (IU/L)
Standard Deviation 57.32
|
82.8 International units per liter (IU/L)
Standard Deviation 44.87
|
77.9 International units per liter (IU/L)
Standard Deviation 40.64
|
77.9 International units per liter (IU/L)
Standard Deviation 37.21
|
81.9 International units per liter (IU/L)
Standard Deviation 40.05
|
88.6 International units per liter (IU/L)
Standard Deviation 53.16
|
|
Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8
ALT, BL, n=106, 104, 101, 102, 98, 99
|
22.3 International units per liter (IU/L)
Standard Deviation 21.25
|
20.0 International units per liter (IU/L)
Standard Deviation 14.75
|
20.5 International units per liter (IU/L)
Standard Deviation 15.44
|
23.4 International units per liter (IU/L)
Standard Deviation 15.65
|
20.4 International units per liter (IU/L)
Standard Deviation 12.70
|
20.6 International units per liter (IU/L)
Standard Deviation 15.83
|
|
Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8
ALT, W8, n=65, 85, 85, 89, 83, 81
|
20.1 International units per liter (IU/L)
Standard Deviation 14.37
|
21.0 International units per liter (IU/L)
Standard Deviation 14.01
|
20.8 International units per liter (IU/L)
Standard Deviation 11.68
|
23.3 International units per liter (IU/L)
Standard Deviation 16.73
|
22.1 International units per liter (IU/L)
Standard Deviation 18.46
|
20.3 International units per liter (IU/L)
Standard Deviation 14.92
|
|
Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8
AST, BL, n=106, 103, 100, 102, 97, 99
|
25.2 International units per liter (IU/L)
Standard Deviation 30.81
|
20.8 International units per liter (IU/L)
Standard Deviation 7.81
|
24.8 International units per liter (IU/L)
Standard Deviation 38.56
|
22.7 International units per liter (IU/L)
Standard Deviation 10.10
|
21.2 International units per liter (IU/L)
Standard Deviation 7.10
|
21.4 International units per liter (IU/L)
Standard Deviation 10.18
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: ITT Population. Only those participants available at the specified time points were analyzed.
Blood samples were collected for the measurement of albumin and total protein at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).
Outcome measures
| Measure |
Placebo
n=106 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=104 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=101 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=102 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=98 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=99 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8
Total protein, W8, n=65, 85, 85, 89, 83, 81
|
72.0 Grams per liter (G/L)
Standard Deviation 4.68
|
72.4 Grams per liter (G/L)
Standard Deviation 4.31
|
73.3 Grams per liter (G/L)
Standard Deviation 5.28
|
72.5 Grams per liter (G/L)
Standard Deviation 3.92
|
73.9 Grams per liter (G/L)
Standard Deviation 4.02
|
72.8 Grams per liter (G/L)
Standard Deviation 4.16
|
|
Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8
Albumin,BL, n=106, 104, 101, 102, 98, 99
|
45.2 Grams per liter (G/L)
Standard Deviation 3.43
|
45.4 Grams per liter (G/L)
Standard Deviation 3.12
|
45.4 Grams per liter (G/L)
Standard Deviation 3.16
|
45.4 Grams per liter (G/L)
Standard Deviation 2.71
|
45.5 Grams per liter (G/L)
Standard Deviation 2.62
|
44.9 Grams per liter (G/L)
Standard Deviation 2.86
|
|
Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8
Albumin, W8, n=65, 85, 85, 89, 83, 81
|
44.0 Grams per liter (G/L)
Standard Deviation 3.06
|
44.7 Grams per liter (G/L)
Standard Deviation 3.08
|
45.1 Grams per liter (G/L)
Standard Deviation 2.81
|
44.6 Grams per liter (G/L)
Standard Deviation 2.81
|
45.3 Grams per liter (G/L)
Standard Deviation 2.91
|
44.5 Grams per liter (G/L)
Standard Deviation 3.19
|
|
Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8
Total protein, BL, n=106, 104, 101, 102, 98, 99
|
74.1 Grams per liter (G/L)
Standard Deviation 5.03
|
73.3 Grams per liter (G/L)
Standard Deviation 4.16
|
73.9 Grams per liter (G/L)
Standard Deviation 4.40
|
73.7 Grams per liter (G/L)
Standard Deviation 4.42
|
74.0 Grams per liter (G/L)
Standard Deviation 4.37
|
73.0 Grams per liter (G/L)
Standard Deviation 4.26
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: ITT Population. Only those participants available at the specified time points were analyzed.
Blood samples were collected for the measurement of chloride, calcium, CO2/BI, cholesterol, glucose, PI, potassium, sodium, and urea/blood urea nitrogen (BUN) at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Outcome measures
| Measure |
Placebo
n=106 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=104 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=101 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=102 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=98 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=99 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
Chloride, BL, n=106, 104, 101, 102, 98, 99
|
104.8 Millimoles per liter (mmol/L)
Standard Deviation 3.06
|
105.0 Millimoles per liter (mmol/L)
Standard Deviation 2.61
|
104.7 Millimoles per liter (mmol/L)
Standard Deviation 3.15
|
104.5 Millimoles per liter (mmol/L)
Standard Deviation 2.34
|
104.8 Millimoles per liter (mmol/L)
Standard Deviation 3.00
|
105.0 Millimoles per liter (mmol/L)
Standard Deviation 2.41
|
|
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
Chloride, W8, n=65, 85, 85, 89, 83, 81
|
104.8 Millimoles per liter (mmol/L)
Standard Deviation 2.31
|
104.3 Millimoles per liter (mmol/L)
Standard Deviation 2.05
|
104.3 Millimoles per liter (mmol/L)
Standard Deviation 2.36
|
104.4 Millimoles per liter (mmol/L)
Standard Deviation 2.20
|
104.0 Millimoles per liter (mmol/L)
Standard Deviation 2.37
|
104.4 Millimoles per liter (mmol/L)
Standard Deviation 2.37
|
|
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
Calcium, BL, n=106, 103, 100, 102, 97, 99
|
2.3 Millimoles per liter (mmol/L)
Standard Deviation 0.12
|
2.3 Millimoles per liter (mmol/L)
Standard Deviation 0.12
|
2.3 Millimoles per liter (mmol/L)
Standard Deviation 0.12
|
2.3 Millimoles per liter (mmol/L)
Standard Deviation 0.10
|
2.3 Millimoles per liter (mmol/L)
Standard Deviation 0.12
|
2.3 Millimoles per liter (mmol/L)
Standard Deviation 0.11
|
|
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
Calcium, W8, n=65, 85, 84, 89, 83, 81
|
2.3 Millimoles per liter (mmol/L)
Standard Deviation 0.12
|
2.3 Millimoles per liter (mmol/L)
Standard Deviation 0.12
|
2.3 Millimoles per liter (mmol/L)
Standard Deviation 0.11
|
2.3 Millimoles per liter (mmol/L)
Standard Deviation 0.11
|
2.3 Millimoles per liter (mmol/L)
Standard Deviation 0.12
|
2.3 Millimoles per liter (mmol/L)
Standard Deviation 0.11
|
|
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
CO2/BI, BL, n=106, 103, 100, 102, 97, 99
|
22.9 Millimoles per liter (mmol/L)
Standard Deviation 2.12
|
22.5 Millimoles per liter (mmol/L)
Standard Deviation 2.67
|
22.7 Millimoles per liter (mmol/L)
Standard Deviation 2.40
|
22.6 Millimoles per liter (mmol/L)
Standard Deviation 2.58
|
22.6 Millimoles per liter (mmol/L)
Standard Deviation 2.24
|
22.6 Millimoles per liter (mmol/L)
Standard Deviation 2.15
|
|
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
CO2/BI, W8, n=65, 85, 85, 89, 83, 81
|
22.4 Millimoles per liter (mmol/L)
Standard Deviation 2.08
|
22.5 Millimoles per liter (mmol/L)
Standard Deviation 2.40
|
22.8 Millimoles per liter (mmol/L)
Standard Deviation 2.72
|
23.1 Millimoles per liter (mmol/L)
Standard Deviation 2.40
|
22.8 Millimoles per liter (mmol/L)
Standard Deviation 2.58
|
22.9 Millimoles per liter (mmol/L)
Standard Deviation 2.37
|
|
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
Cholesterol, BL, n=106, 104, 101, 102, 98, 99
|
5.0 Millimoles per liter (mmol/L)
Standard Deviation 1.09
|
5.0 Millimoles per liter (mmol/L)
Standard Deviation 1.21
|
4.9 Millimoles per liter (mmol/L)
Standard Deviation 1.07
|
5.2 Millimoles per liter (mmol/L)
Standard Deviation 1.13
|
5.2 Millimoles per liter (mmol/L)
Standard Deviation 1.16
|
5.0 Millimoles per liter (mmol/L)
Standard Deviation 1.12
|
|
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
Cholesterol, W8, n=65, 85, 85, 89, 83, 81
|
4.9 Millimoles per liter (mmol/L)
Standard Deviation 1.06
|
5.0 Millimoles per liter (mmol/L)
Standard Deviation 1.19
|
4.9 Millimoles per liter (mmol/L)
Standard Deviation 1.03
|
5.1 Millimoles per liter (mmol/L)
Standard Deviation 1.08
|
5.1 Millimoles per liter (mmol/L)
Standard Deviation 1.11
|
4.9 Millimoles per liter (mmol/L)
Standard Deviation 1.05
|
|
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
Glucose, BL, n=106, 103, 100, 102, 98, 99
|
5.2 Millimoles per liter (mmol/L)
Standard Deviation 0.94
|
5.4 Millimoles per liter (mmol/L)
Standard Deviation 1.95
|
5.1 Millimoles per liter (mmol/L)
Standard Deviation 0.70
|
5.2 Millimoles per liter (mmol/L)
Standard Deviation 0.84
|
5.5 Millimoles per liter (mmol/L)
Standard Deviation 2.18
|
5.5 Millimoles per liter (mmol/L)
Standard Deviation 1.88
|
|
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
Glucose, W8, n=65, 85, 85, 89, 83, 81
|
5.0 Millimoles per liter (mmol/L)
Standard Deviation 0.73
|
5.2 Millimoles per liter (mmol/L)
Standard Deviation 1.66
|
5.1 Millimoles per liter (mmol/L)
Standard Deviation 1.04
|
5.2 Millimoles per liter (mmol/L)
Standard Deviation 1.06
|
5.0 Millimoles per liter (mmol/L)
Standard Deviation 1.46
|
5.3 Millimoles per liter (mmol/L)
Standard Deviation 1.85
|
|
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
PI, BL, n=106, 104, 101, 102, 98, 99
|
1.2 Millimoles per liter (mmol/L)
Standard Deviation 0.20
|
1.2 Millimoles per liter (mmol/L)
Standard Deviation 0.22
|
1.2 Millimoles per liter (mmol/L)
Standard Deviation 0.33
|
1.2 Millimoles per liter (mmol/L)
Standard Deviation 0.19
|
1.2 Millimoles per liter (mmol/L)
Standard Deviation 0.19
|
1.1 Millimoles per liter (mmol/L)
Standard Deviation 0.22
|
|
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
PI, W8, n=65, 85, 85, 89, 83, 81
|
1.3 Millimoles per liter (mmol/L)
Standard Deviation 0.21
|
1.3 Millimoles per liter (mmol/L)
Standard Deviation 0.17
|
1.2 Millimoles per liter (mmol/L)
Standard Deviation 0.18
|
1.2 Millimoles per liter (mmol/L)
Standard Deviation 0.17
|
1.3 Millimoles per liter (mmol/L)
Standard Deviation 0.26
|
1.3 Millimoles per liter (mmol/L)
Standard Deviation 0.19
|
|
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
Potassium, BL, n=106, 103, 100, 102, 97, 98
|
4.2 Millimoles per liter (mmol/L)
Standard Deviation 0.41
|
4.1 Millimoles per liter (mmol/L)
Standard Deviation 0.45
|
4.1 Millimoles per liter (mmol/L)
Standard Deviation 0.44
|
4.2 Millimoles per liter (mmol/L)
Standard Deviation 0.46
|
4.2 Millimoles per liter (mmol/L)
Standard Deviation 0.38
|
4.1 Millimoles per liter (mmol/L)
Standard Deviation 0.41
|
|
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
Potassium, W8, n=65, 85, 84, 89, 83, 81
|
4.2 Millimoles per liter (mmol/L)
Standard Deviation 0.64
|
4.2 Millimoles per liter (mmol/L)
Standard Deviation 0.53
|
4.3 Millimoles per liter (mmol/L)
Standard Deviation 0.63
|
4.2 Millimoles per liter (mmol/L)
Standard Deviation 0.44
|
4.3 Millimoles per liter (mmol/L)
Standard Deviation 0.66
|
4.2 Millimoles per liter (mmol/L)
Standard Deviation 0.34
|
|
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
Sodium, BL, n=106, 104, 101, 102, 98, 99
|
140.7 Millimoles per liter (mmol/L)
Standard Deviation 3.38
|
140.6 Millimoles per liter (mmol/L)
Standard Deviation 1.91
|
141.0 Millimoles per liter (mmol/L)
Standard Deviation 3.13
|
140.3 Millimoles per liter (mmol/L)
Standard Deviation 2.07
|
140.7 Millimoles per liter (mmol/L)
Standard Deviation 2.85
|
140.5 Millimoles per liter (mmol/L)
Standard Deviation 1.76
|
|
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
Sodium, W8, n=65, 85, 85, 89, 83, 81
|
139.9 Millimoles per liter (mmol/L)
Standard Deviation 2.11
|
140.0 Millimoles per liter (mmol/L)
Standard Deviation 1.95
|
140.3 Millimoles per liter (mmol/L)
Standard Deviation 2.05
|
140.5 Millimoles per liter (mmol/L)
Standard Deviation 2.15
|
140.3 Millimoles per liter (mmol/L)
Standard Deviation 2.23
|
140.2 Millimoles per liter (mmol/L)
Standard Deviation 1.80
|
|
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
BUN, BL, n=106, 104, 101, 102, 98, 99
|
5.3 Millimoles per liter (mmol/L)
Standard Deviation 1.87
|
5.1 Millimoles per liter (mmol/L)
Standard Deviation 2.07
|
5.1 Millimoles per liter (mmol/L)
Standard Deviation 1.90
|
4.9 Millimoles per liter (mmol/L)
Standard Deviation 1.61
|
5.2 Millimoles per liter (mmol/L)
Standard Deviation 2.20
|
5.3 Millimoles per liter (mmol/L)
Standard Deviation 1.78
|
|
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
BUN, W8, n=65, 85, 85, 89, 83, 81
|
5.2 Millimoles per liter (mmol/L)
Standard Deviation 1.42
|
4.9 Millimoles per liter (mmol/L)
Standard Deviation 1.47
|
5.0 Millimoles per liter (mmol/L)
Standard Deviation 1.61
|
5.0 Millimoles per liter (mmol/L)
Standard Deviation 1.68
|
4.8 Millimoles per liter (mmol/L)
Standard Deviation 1.60
|
5.2 Millimoles per liter (mmol/L)
Standard Deviation 1.64
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: ITT Population. Only those participants available at the specified time points were analyzed.
Blood samples were collected for the measurement of DBIL, TBIL, uric acid and creatinine at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Outcome measures
| Measure |
Placebo
n=106 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=104 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=101 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=102 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=98 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=99 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8
Creatinine, W8, n=65, 85, 85, 89, 83, 81
|
74.4 Micromoles per liter (µmol/L)
Standard Deviation 15.58
|
74.6 Micromoles per liter (µmol/L)
Standard Deviation 14.95
|
78.5 Micromoles per liter (µmol/L)
Standard Deviation 16.79
|
76.9 Micromoles per liter (µmol/L)
Standard Deviation 15.97
|
76.2 Micromoles per liter (µmol/L)
Standard Deviation 15.18
|
77.2 Micromoles per liter (µmol/L)
Standard Deviation 16.59
|
|
Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8
DBIL, BL, n=106, 103, 100, 101, 98, 98
|
2.1 Micromoles per liter (µmol/L)
Standard Deviation 1.23
|
2.0 Micromoles per liter (µmol/L)
Standard Deviation 1.30
|
1.9 Micromoles per liter (µmol/L)
Standard Deviation 1.09
|
1.9 Micromoles per liter (µmol/L)
Standard Deviation 1.09
|
2.1 Micromoles per liter (µmol/L)
Standard Deviation 0.97
|
1.8 Micromoles per liter (µmol/L)
Standard Deviation 0.90
|
|
Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8
DBIL, W8, n=65, 65, 85, 89, 83, 81
|
1.8 Micromoles per liter (µmol/L)
Standard Deviation 0.97
|
2.0 Micromoles per liter (µmol/L)
Standard Deviation 1.09
|
1.9 Micromoles per liter (µmol/L)
Standard Deviation 0.88
|
1.9 Micromoles per liter (µmol/L)
Standard Deviation 0.88
|
1.8 Micromoles per liter (µmol/L)
Standard Deviation 0.93
|
1.7 Micromoles per liter (µmol/L)
Standard Deviation 0.75
|
|
Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8
TBIL, BL, n=106, 104, 101, 102, 98, 99
|
10.2 Micromoles per liter (µmol/L)
Standard Deviation 5.39
|
10.6 Micromoles per liter (µmol/L)
Standard Deviation 6.11
|
9.4 Micromoles per liter (µmol/L)
Standard Deviation 5.20
|
9.3 Micromoles per liter (µmol/L)
Standard Deviation 4.65
|
9.7 Micromoles per liter (µmol/L)
Standard Deviation 5.48
|
8.9 Micromoles per liter (µmol/L)
Standard Deviation 4.02
|
|
Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8
TBIL, W8, n=65, 85, 85, 89, 83, 81
|
8.5 Micromoles per liter (µmol/L)
Standard Deviation 4.38
|
9.6 Micromoles per liter (µmol/L)
Standard Deviation 6.13
|
9.2 Micromoles per liter (µmol/L)
Standard Deviation 4.93
|
8.8 Micromoles per liter (µmol/L)
Standard Deviation 4.14
|
9.2 Micromoles per liter (µmol/L)
Standard Deviation 4.08
|
8.4 Micromoles per liter (µmol/L)
Standard Deviation 3.03
|
|
Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8
Uric acid, BL, n=106, 104, 101, 102, 98, 99
|
326.7 Micromoles per liter (µmol/L)
Standard Deviation 93.33
|
323.2 Micromoles per liter (µmol/L)
Standard Deviation 83.60
|
319.4 Micromoles per liter (µmol/L)
Standard Deviation 94.90
|
326.7 Micromoles per liter (µmol/L)
Standard Deviation 95.36
|
323.9 Micromoles per liter (µmol/L)
Standard Deviation 82.30
|
312.7 Micromoles per liter (µmol/L)
Standard Deviation 85.72
|
|
Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8
Uric acid, W8, n=65, 85, 85, 89, 83, 81
|
308.8 Micromoles per liter (µmol/L)
Standard Deviation 89.18
|
318.3 Micromoles per liter (µmol/L)
Standard Deviation 84.85
|
319.7 Micromoles per liter (µmol/L)
Standard Deviation 93.76
|
314.4 Micromoles per liter (µmol/L)
Standard Deviation 94.26
|
321.1 Micromoles per liter (µmol/L)
Standard Deviation 83.68
|
311.4 Micromoles per liter (µmol/L)
Standard Deviation 90.62
|
|
Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8
Creatinine, BL, n=106, 104, 101, 102, 98, 99
|
77.9 Micromoles per liter (µmol/L)
Standard Deviation 14.57
|
77.9 Micromoles per liter (µmol/L)
Standard Deviation 18.60
|
77.8 Micromoles per liter (µmol/L)
Standard Deviation 16.50
|
75.9 Micromoles per liter (µmol/L)
Standard Deviation 15.04
|
75.9 Micromoles per liter (µmol/L)
Standard Deviation 18.24
|
77.7 Micromoles per liter (µmol/L)
Standard Deviation 15.77
|
SECONDARY outcome
Timeframe: Baseline and Week 8/Early WithdrawalPopulation: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, 3+ and 4+, and for UG the result can be read as Neg, Trace, Trace or 1/10 grams per deciliter (G/dL), 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, Trace, 1+, 2+, 3+ and 4+ levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (WD). The Baseline value was the measurement taken at screening (Visit 1).
Outcome measures
| Measure |
Placebo
n=102 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=101 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=98 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=99 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=94 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=97 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UOB, Neg, BL, n=102, 101, 98, 99, 94, 95
|
96 Participants
|
91 Participants
|
85 Participants
|
90 Participants
|
81 Participants
|
91 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UOB, Trace, BL, n=102, 101, 98, 99, 94, 97
|
4 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
8 Participants
|
2 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UOB, 1+, BL, n=102, 101, 98, 99, 94, 97
|
1 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UOB, 2+, BL, n=102, 101, 98, 99, 94, 97
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UOB, 3+, BL, n=102, 101, 98, 99, 94, 97
|
1 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UOB, Neg, W8, n=63, 85, 84, 82, 82, 82
|
56 Participants
|
77 Participants
|
77 Participants
|
73 Participants
|
73 Participants
|
72 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UOB, Trace, W8, n=63, 85, 84, 82, 82, 82
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UOB, 1+, W8, n=63, 85, 84, 82, 82, 82
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UOB, 2+, W8, n=63, 85, 84, 82, 82, 82
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UOB, 3+, W8, n=63, 85, 84, 82, 82, 82
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UOB, Neg, WD, n=9, 4, 1, 2, 3, 7
|
9 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UOB, 2+, WD, n=9, 4, 1, 2, 3, 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UG, Neg, BL, n=102, 101, 98, 99, 94, 97
|
100 Participants
|
98 Participants
|
98 Participants
|
98 Participants
|
91 Participants
|
94 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UG, Trace, BL, n=102, 101, 98, 99, 94, 97
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UG, Trace or 1/10 G/DL, BL, n=102, 101,98,99,94,97
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UG, 1+ or 1/3 G/DL, BL, n=102, 101, 98, 99, 94, 97
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UG, 3+ or 1 G/DL, BL, n=102, 101, 98, 99, 94, 97
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UG, Neg,W8, n=63, 85, 84, 82, 82, 82
|
62 Participants
|
83 Participants
|
83 Participants
|
81 Participants
|
82 Participants
|
80 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UG, Trace, W8, n=63, 85, 84, 82, 82, 82
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UG, 1+ or 1/4 G/DL, W8, n=63, 85, 84, 82, 82, 82
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UG, 3+ or 1 G/DL, W8, n=63, 85, 84, 82, 82, 82
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UG, Neg, WD, n=9, 4, 1, 2, 3, 7
|
9 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UK, Neg, BL, n=102, 101, 98, 99, 94, 97
|
97 Participants
|
96 Participants
|
96 Participants
|
96 Participants
|
90 Participants
|
94 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UK, Trace, BL, n=102, 101, 98, 99, 94, 97
|
5 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UK, 1+, BL, n=102, 101, 98, 99, 94, 97
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UK, 2+, BL, n=102, 101, 98, 99, 94, 97
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UK, Neg, W8, n=63, 85, 84, 82, 82, 82
|
61 Participants
|
80 Participants
|
81 Participants
|
78 Participants
|
75 Participants
|
80 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UK, Trace, W8, n=63, 85, 84, 82, 82, 82
|
2 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UK, 1+, W8, n=63, 85, 84, 82, 82, 82
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UK, Neg, WD, n=9, 4, 1, 2, 3, 7
|
9 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UP, Neg, BL, n=102, 101, 98, 99, 94, 97
|
76 Participants
|
78 Participants
|
77 Participants
|
78 Participants
|
70 Participants
|
75 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UP, Trace, BL, n=102, 101, 98, 99, 94, 97
|
19 Participants
|
14 Participants
|
13 Participants
|
13 Participants
|
17 Participants
|
11 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UP, 1+, BL, n=102, 101, 98, 99, 94, 97
|
6 Participants
|
6 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
11 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UP, 2+, BL, n=102, 101, 98, 99, 94, 97
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UP, 3+, BL, n=102, 101, 98, 99, 94, 97
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UP, Neg, W8, n=63, 85, 84, 82, 82, 82
|
54 Participants
|
64 Participants
|
68 Participants
|
65 Participants
|
63 Participants
|
61 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UP, Trace, W8, n=63, 85, 84, 82, 82, 82
|
6 Participants
|
14 Participants
|
8 Participants
|
12 Participants
|
17 Participants
|
15 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UP, 1+, W8, n=63, 85, 84, 82, 82, 82
|
3 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UP, 2+, W8,n=63, 85, 84, 82, 82, 82
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UP, 3+, W8, n=63, 85, 84, 82, 82, 82
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UP, 4+, W8, n=63, 85, 84, 82, 82, 82
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UP, Neg, WD, n=9, 4, 1, 2, 3, 7
|
8 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UP, Trace, WD, n=9, 4, 1, 2, 3, 7
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UP, 1+, WD, n=9, 4, 1, 2, 3, 7
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UWBC, Neg, BL, n=102, 101, 98, 99, 94, 97
|
86 Participants
|
87 Participants
|
82 Participants
|
81 Participants
|
74 Participants
|
88 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UWBC, Trace, BL, n=102, 101, 98, 99, 94, 97
|
2 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UWBC, 1+, BL, n=102, 101, 98, 99, 94. 97
|
6 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
8 Participants
|
3 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UWBC, 2+, BL, n=102, 101, 98, 99, 94, 97
|
7 Participants
|
3 Participants
|
2 Participants
|
8 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UWBC, 3+, BL, n=102, 101, 98, 99, 94, 97
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UWBC, Neg, W8, n=63, 85, 84, 82, 82, 82
|
52 Participants
|
65 Participants
|
71 Participants
|
62 Participants
|
63 Participants
|
69 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UWBC, Trace, W8, n=63, 85, 84, 82, 82, 82
|
3 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UWBC, 1+, W8, n=63, 85, 84, 82, 82, 82
|
7 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UWBC, 2+, W8, n=63, 85, 84, 82, 82, 82
|
1 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UWBC, 3+, W8, n=63, 85, 84, 82, 82, 82
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UWBC, Neg, WD, n=9, 4, 1, 2, 3, 7
|
9 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
UWBC, 2+, WD, n=9, 4, 1, 2, 3, 7
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Urine specific gravity at Baseline and Week 8/Early WithdrawalPopulation: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.
Outcome measures
| Measure |
Placebo
n=102 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=104 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=96 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=99 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=94 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=97 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Urine Specific Gravity at Baseline and Week 8/Early Withdrawal
BL, n=102, 101, 98, 99, 94, 97
|
1.0232 ratio
Standard Deviation 0.00741
|
1.0227 ratio
Standard Deviation 0.00687
|
1.0226 ratio
Standard Deviation 0.00718
|
1.0224 ratio
Standard Deviation 0.00719
|
1.0225 ratio
Standard Deviation 0.00759
|
1.0245 ratio
Standard Deviation 0.00679
|
|
Urine Specific Gravity at Baseline and Week 8/Early Withdrawal
W8, n=63, 85, 84, 82, 82, 82
|
1.0225 ratio
Standard Deviation 0.00778
|
1.0227 ratio
Standard Deviation 0.00714
|
1.0227 ratio
Standard Deviation 0.00655
|
1.0223 ratio
Standard Deviation 0.00766
|
1.0210 ratio
Standard Deviation 0.00884
|
1.0255 ratio
Standard Deviation 0.00726
|
|
Urine Specific Gravity at Baseline and Week 8/Early Withdrawal
WD, n=9, 4, 1, 2, 3, 7
|
1.0206 ratio
Standard Deviation 0.00532
|
1.0228 ratio
Standard Deviation 0.00772
|
1.0380 ratio
Standard Deviation 0
|
1.0175 ratio
Standard Deviation 0.01768
|
1.0273 ratio
Standard Deviation 0.00306
|
1.0164 ratio
Standard Deviation 0.00824
|
SECONDARY outcome
Timeframe: Baseline and Week 8/Early WithdrawalPopulation: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Outcome measures
| Measure |
Placebo
n=102 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=104 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=96 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=99 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=94 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=97 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Urine pH at Baseline and Week 8/Early Withdrawal
BL, n=102, 104, 96, 99, 94, 97
|
6.11 scores on a scale
Standard Deviation 0.507
|
5.98 scores on a scale
Standard Deviation 0.367
|
6.05 scores on a scale
Standard Deviation 0.455
|
5.97 scores on a scale
Standard Deviation 0.383
|
6.01 scores on a scale
Standard Deviation 0.370
|
6.04 scores on a scale
Standard Deviation 0.393
|
|
Urine pH at Baseline and Week 8/Early Withdrawal
W8, n=62, 84, 82, 83, 82, 82
|
6.00 scores on a scale
Standard Deviation 0.458
|
6.13 scores on a scale
Standard Deviation 0.518
|
6.10 scores on a scale
Standard Deviation 0.451
|
5.99 scores on a scale
Standard Deviation 0.397
|
6.00 scores on a scale
Standard Deviation 0.437
|
6.01 scores on a scale
Standard Deviation 0.368
|
|
Urine pH at Baseline and Week 8/Early Withdrawal
WD, n=9, 4, 1, 2, 3, 7
|
6.11 scores on a scale
Standard Deviation 0.601
|
6.13 scores on a scale
Standard Deviation 0.250
|
6.00 scores on a scale
Standard Deviation 0
|
6.00 scores on a scale
Standard Deviation 0.000
|
5.67 scores on a scale
Standard Deviation 0.289
|
5.93 scores on a scale
Standard Deviation 0.345
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Urine Cortisol (UC) Population: all participants whose urine samples did not have confounding factors that could affect the interpretation of results.
A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visit 3 (Baseline; Week 0) and Study Visit 8 (Week 8). The Baseline value for 24-hour urinary cortisol was taken from Visit 3.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=69 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=75 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=75 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=72 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=70 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
24-hour Urinary Cortisol Excretion at Baseline and Week 8
Baseline
|
68.45 Nanomole per 24 hours (nmol/24hr)
Interval 12.9 to 261.2
|
56.80 Nanomole per 24 hours (nmol/24hr)
Interval 6.8 to 385.4
|
65.90 Nanomole per 24 hours (nmol/24hr)
Interval 9.6 to 463.5
|
64.50 Nanomole per 24 hours (nmol/24hr)
Interval 20.1 to 311.0
|
73.40 Nanomole per 24 hours (nmol/24hr)
Interval 12.5 to 221.7
|
75.69 Nanomole per 24 hours (nmol/24hr)
Interval 17.9 to 384.8
|
|
24-hour Urinary Cortisol Excretion at Baseline and Week 8
Week 8
|
64.70 Nanomole per 24 hours (nmol/24hr)
Interval 7.6 to 200.0
|
60.80 Nanomole per 24 hours (nmol/24hr)
Interval 13.9 to 262.1
|
53.00 Nanomole per 24 hours (nmol/24hr)
Interval 9.2 to 371.5
|
56.00 Nanomole per 24 hours (nmol/24hr)
Interval 5.4 to 340.0
|
62.00 Nanomole per 24 hours (nmol/24hr)
Interval 7.7 to 294.3
|
58.39 Nanomole per 24 hours (nmol/24hr)
Interval 8.0 to 338.5
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: ITT Population. Only those participants available at the specified time points were analyzed.
Change from Baseline was calculated as the Week 8 value minus the Baseline value.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=105 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=101 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=103 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=99 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=100 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8
SBP
|
0.8 Millimeters of mercury (mmHg)
Standard Deviation 9.83
|
0.3 Millimeters of mercury (mmHg)
Standard Deviation 12.93
|
-0.2 Millimeters of mercury (mmHg)
Standard Deviation 12.06
|
0.9 Millimeters of mercury (mmHg)
Standard Deviation 11.51
|
0.9 Millimeters of mercury (mmHg)
Standard Deviation 10.55
|
1.1 Millimeters of mercury (mmHg)
Standard Deviation 11.49
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8
DBP
|
2.1 Millimeters of mercury (mmHg)
Standard Deviation 6.96
|
0.6 Millimeters of mercury (mmHg)
Standard Deviation 9.19
|
-0.3 Millimeters of mercury (mmHg)
Standard Deviation 9.18
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 9.37
|
-0.2 Millimeters of mercury (mmHg)
Standard Deviation 8.05
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation 7.90
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: ITT Population. Only those participants available at the specified time points were analyzed.
Change from Baseline was calculated as the Week 8 value minus the Baseline value.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=105 Participants
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=101 Participants
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=103 Participants
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=99 Participants
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=100 Participants
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Heart Rate at Week 8
|
0.8 Beats per minute
Standard Deviation 10.12
|
0.5 Beats per minute
Standard Deviation 7.65
|
-0.4 Beats per minute
Standard Deviation 8.90
|
1.5 Beats per minute
Standard Deviation 10.92
|
0.5 Beats per minute
Standard Deviation 8.55
|
-1.7 Beats per minute
Standard Deviation 9.68
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
GW685698X 100 µg OD
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
GW685698X 200 µg OD
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
GW685698X 300 µg OD
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
GW685698X 400 µg OD
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
FP 250 µg BID
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=107 participants at risk
Participants received placebo once daily OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=105 participants at risk
Participants received GW685698X 100 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=101 participants at risk
Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=103 participants at risk
Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=99 participants at risk
Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=100 participants at risk
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/107 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/105 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/101 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.97%
1/103 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/99 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/100 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/107 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/105 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/101 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/103 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
1.0%
1/99 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/100 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
Other adverse events
| Measure |
Placebo
n=107 participants at risk
Participants received placebo once daily OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
GW685698X 100 µg OD
n=105 participants at risk
Participants received GW685698X 100 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 200 µg OD
n=101 participants at risk
Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 300 µg OD
n=103 participants at risk
Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
GW685698X 400 µg OD
n=99 participants at risk
Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
FP 250 µg BID
n=100 participants at risk
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.5%
8/107 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
8.6%
9/105 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
5.0%
5/101 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
6.8%
7/103 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
4.0%
4/99 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
7.0%
7/100 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
3/107 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
1.9%
2/105 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
3.0%
3/101 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.97%
1/103 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/99 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
6.0%
6/100 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/107 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
2.9%
3/105 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.99%
1/101 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
2.9%
3/103 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
3.0%
3/99 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
3.0%
3/100 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Sinusitis
|
0.93%
1/107 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
1.9%
2/105 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/101 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/103 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
1.0%
1/99 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
3.0%
3/100 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Nervous system disorders
Headache
|
5.6%
6/107 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
8.6%
9/105 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
7.9%
8/101 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
7.8%
8/103 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
9.1%
9/99 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
8.0%
8/100 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.93%
1/107 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
1.9%
2/105 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/101 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
1.9%
2/103 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
4.0%
4/99 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
2.0%
2/100 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.93%
1/107 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.95%
1/105 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/101 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
1.9%
2/103 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
2.0%
2/99 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
4.0%
4/100 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/107 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
1.9%
2/105 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.99%
1/101 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.97%
1/103 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
3.0%
3/99 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
3.0%
3/100 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/107 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
3.8%
4/105 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.99%
1/101 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.97%
1/103 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
1.0%
1/99 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
1.0%
1/100 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/107 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
1.9%
2/105 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.99%
1/101 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.97%
1/103 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
3.0%
3/99 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/100 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/107 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.95%
1/105 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.99%
1/101 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/103 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/99 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
3.0%
3/100 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/107 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.95%
1/105 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.99%
1/101 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
2.9%
3/103 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
3.0%
3/99 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
2.0%
2/100 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER