Trial Outcomes & Findings for Dose-Ranging Study Of GSK233705B In Subjects With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00676052)
NCT ID: NCT00676052
Last Updated: 2017-10-09
Results Overview
The trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 28. The Baseline FEV1 is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose \[time 0\] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
576 participants
Primary outcome timeframe
Baseline (pre-dose Day 1) and Day 29
Results posted on
2017-10-09
Participant Flow
This study was conducted across 79 centers: 30 in North America, 28 in Europe and 21 in International regions. The first participant first visit was on 16 May 2008 and last participant last visit was on 22 December 2008.
Out of the 963 participants screened for this study, 303 participants were screen failures and 79 participants were run-in failures. Therefore, a total of 581 participants were randomized out of which 5 participants did not receive any study medication, thus 576 participants were included in the intent-to-treat (ITT) Population.
Participant milestones
| Measure |
Placebo
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
|
GSK233705B 12.5 mcg
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 micrograms (mcg) administered once daily via a novel dry powder inhaler.
|
GSK233705B 25 mcg
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 50 mcg
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 100 mcg
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 200 mcg
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
96
|
95
|
96
|
97
|
95
|
97
|
|
Overall Study
COMPLETED
|
87
|
88
|
90
|
92
|
89
|
91
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
6
|
5
|
6
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
|
GSK233705B 12.5 mcg
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 micrograms (mcg) administered once daily via a novel dry powder inhaler.
|
GSK233705B 25 mcg
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 50 mcg
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 100 mcg
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 200 mcg
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
2
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
1
|
1
|
2
|
1
|
|
Overall Study
Protocol Violation
|
5
|
3
|
2
|
2
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
1
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Dose-Ranging Study Of GSK233705B In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Placebo
n=96 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
|
GSK233705B 12.5 mcg
n=95 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 25 mcg
n=96 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 50 mcg
n=97 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 100 mcg
n=95 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 200 mcg
n=97 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
|
Total
n=576 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.4 Years
STANDARD_DEVIATION 8.73 • n=5 Participants
|
62.2 Years
STANDARD_DEVIATION 9.75 • n=7 Participants
|
62.2 Years
STANDARD_DEVIATION 8.70 • n=5 Participants
|
62.8 Years
STANDARD_DEVIATION 6.99 • n=4 Participants
|
61.7 Years
STANDARD_DEVIATION 8.77 • n=21 Participants
|
64.1 Years
STANDARD_DEVIATION 8.30 • n=10 Participants
|
62.4 Years
STANDARD_DEVIATION 8.58 • n=115 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
235 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
63 Participants
n=10 Participants
|
341 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
43 Participants
n=115 Participants
|
|
Race (NIH/OMB)
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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
84 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
85 Participants
n=10 Participants
|
512 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Day 1) and Day 29Population: ITT Population. Last observation carried forward (LOCF) data has been presented.
The trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 28. The Baseline FEV1 is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose \[time 0\] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.
Outcome measures
| Measure |
GSK233705B 12.5 mcg
n=94 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 25 mcg
n=94 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 50 mcg
n=97 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 100 mcg
n=94 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 200 mcg
n=96 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
|
Placebo
n=94 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29
|
0.058 Liter
Standard Error 0.0180
|
0.088 Liter
Standard Error 0.0180
|
0.060 Liter
Standard Error 0.0178
|
0.073 Liter
Standard Error 0.0181
|
0.128 Liter
Standard Error 0.0179
|
-0.009 Liter
Standard Error 0.0181
|
SECONDARY outcome
Timeframe: Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29Population: ITT Population. Participants with analyzable data on the indicated time point have been presented.
Weighted means serial FEV1 was derived by calculating the area under curve (AUC), and then dividing by the time interval over which the AUC was calculated. Baseline was defined at pre-dose Day 1. The weighted mean change from Baseline is the weighted mean minus Baseline. The AUC was calculated using the trapezoidal rule. For all post-dose observations, actual times that the spirometry measurements were conducted was used for the calculation. Pre-dose observations were counted as 0 hr observations - that is they had their time set to the time of dosing. The pre-dose value used for the calculation of the AUC was the mean of the two pre-dose observations (-30 and 0 min for Day 1 or 28). If one of these observations was missing, the remaining single pre-dose observation was used.
Outcome measures
| Measure |
GSK233705B 12.5 mcg
n=94 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 25 mcg
n=95 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 50 mcg
n=97 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 100 mcg
n=94 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 200 mcg
n=97 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
|
Placebo
n=94 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Weighted Mean for 0 to 24 Hours Serial FEV1 on Day 1 to 2 and 28 to 29
FEV1, Day 1
|
0.085 Liter
Standard Error 0.0146
|
0.086 Liter
Standard Error 0.0146
|
0.102 Liter
Standard Error 0.0143
|
0.132 Liter
Standard Error 0.0146
|
0.155 Liter
Standard Error 0.0144
|
-0.021 Liter
Standard Error 0.0146
|
|
Change From Baseline in Weighted Mean for 0 to 24 Hours Serial FEV1 on Day 1 to 2 and 28 to 29
FEV1, Day 28
|
0.087 Liter
Standard Error 0.0180
|
0.122 Liter
Standard Error 0.0179
|
0.105 Liter
Standard Error 0.0178
|
0.122 Liter
Standard Error 0.0180
|
0.150 Liter
Standard Error 0.0178
|
-0.020 Liter
Standard Error 0.0182
|
SECONDARY outcome
Timeframe: Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29Population: ITT Population. Participants with analyzable data on the indicated time point have been presented.
Weighted means serial FVC was derived by calculating the AUC, and then dividing by the time interval over which the AUC was calculated. Baseline was defined at pre-dose Day 1. The weighted mean change from Baseline is the weighted mean minus Baseline. The AUC was calculated using the trapezoidal rule. For all post-dose observations, actual times that the spirometry measurements were conducted was used for the calculation. Pre-dose observations were counted as 0 hr observations - that is they had their time set to the time of dosing. The pre-dose value used for the calculation of the AUC was the mean of the two pre-dose observations (-30 and 0 min for Day 1 or 28). If one of these observations was missing, the remaining single pre-dose observation was used.
Outcome measures
| Measure |
GSK233705B 12.5 mcg
n=94 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 25 mcg
n=95 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 50 mcg
n=97 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 100 mcg
n=94 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 200 mcg
n=97 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
|
Placebo
n=94 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Weighted Mean for 0 to 24 Hours Forced Vital Capacity (FVC) on Day 1 to 2 and 28 to 29
Day 1
|
0.129 Liter
Standard Error 0.0257
|
0.149 Liter
Standard Error 0.0257
|
0.160 Liter
Standard Error 0.0253
|
0.207 Liter
Standard Error 0.0257
|
0.263 Liter
Standard Error 0.0257
|
-0.037 Liter
Standard Error 0.0257
|
|
Change From Baseline in Weighted Mean for 0 to 24 Hours Forced Vital Capacity (FVC) on Day 1 to 2 and 28 to 29
Day 28
|
0.137 Liter
Standard Error 0.0287
|
0.178 Liter
Standard Error 0.0285
|
0.150 Liter
Standard Error 0.0283
|
0.191 Liter
Standard Error 0.0287
|
0.253 Liter
Standard Error 0.0283
|
-0.041 Liter
Standard Error 0.0289
|
SECONDARY outcome
Timeframe: Baseline (pre-dose Day 1) and Day 29Population: ITT Population. Participants with analyzable data on the indicated time point have been presented.
The trough FVC is defined as the mean of the FVC values obtained 23 and 24 hours after dosing on Day 28. The Baseline FVC is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose \[time 0\] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.
Outcome measures
| Measure |
GSK233705B 12.5 mcg
n=88 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 25 mcg
n=90 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 50 mcg
n=91 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 100 mcg
n=89 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 200 mcg
n=91 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
|
Placebo
n=87 Participants
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinic Visit Trough FVC on Day 29
|
0.088 Liter
Standard Error 0.0301
|
0.139 Liter
Standard Error 0.0298
|
0.083 Liter
Standard Error 0.0295
|
0.152 Liter
Standard Error 0.0300
|
0.224 Liter
Standard Error 0.0297
|
-0.011 Liter
Standard Error 0.0301
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
GSK233705B 12.5 mcg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
GSK233705B 25 mcg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
GSK233705B 50 mcg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
GSK233705B 100 mcg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
GSK233705B 200 mcg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=96 participants at risk
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
|
GSK233705B 12.5 mcg
n=95 participants at risk
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 25 mcg
n=96 participants at risk
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 50 mcg
n=97 participants at risk
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 100 mcg
n=95 participants at risk
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 200 mcg
n=97 participants at risk
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/96 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/95 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
1.0%
1/96 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/97 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/95 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/97 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/96 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/95 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/96 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/97 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
1.1%
1/95 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/97 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/96 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/95 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/96 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
1.0%
1/97 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/95 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/97 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/96 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/95 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/96 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/97 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/95 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
1.0%
1/97 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/96 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/95 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
1.0%
1/96 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/97 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/95 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
0.00%
0/97 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
Other adverse events
| Measure |
Placebo
n=96 participants at risk
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
|
GSK233705B 12.5 mcg
n=95 participants at risk
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 25 mcg
n=96 participants at risk
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 50 mcg
n=97 participants at risk
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 100 mcg
n=95 participants at risk
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
|
GSK233705B 200 mcg
n=97 participants at risk
Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
7.3%
7/96 • Number of events 9 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
4.2%
4/95 • Number of events 4 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
6.2%
6/96 • Number of events 6 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
9.3%
9/97 • Number of events 14 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
5.3%
5/95 • Number of events 7 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
3.1%
3/97 • Number of events 3 • Adverse events (AEs) were collected up to follow visit (7 to 9 days post visit 8 or premature discontinuation).
ITT Population was used in the analysis of safety data.
|
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