Trial Outcomes & Findings for Efficacy And Safety Of GW642444M Comparing Placebo In Adolescent And Adult Subjects With Persistent Asthma. (NCT NCT00600171)
NCT ID: NCT00600171
Last Updated: 2016-12-16
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. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 28-day treatment period, with the trough FEV1 defined as the mean of the 23 hour and 24 hour post-dose assessments on Day 28. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) using LOCF with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, and treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
614 participants
Primary outcome timeframe
Baseline and Day 28
Results posted on
2016-12-16
Participant Flow
614 participants were randomized to study drug; however, 7 of these participants were randomized in error and did not receive any study drug. 607 participants comprised the Intent-to-Treat Population (all participants randomized to treatment and who received at least one dose of study medication).
Participants were screened (Visit 1), for eligibility, which included the inhaled albuterol/salbutamol reversibility test. Following screening and a 14-day Run-in period, participants meeting eligibility criteria were stratified in an approximately 1:1 ratio according to their Baseline Forced Expiratory Volume per one second (FEV1).
Participant milestones
| Measure |
Placebo
Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 3 µg
Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 6.25 µg
Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 12.5 µg
Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 25 µg
Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 50 µg
Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
102
|
101
|
101
|
100
|
101
|
102
|
|
Overall Study
COMPLETED
|
86
|
84
|
91
|
88
|
93
|
97
|
|
Overall Study
NOT COMPLETED
|
16
|
17
|
10
|
12
|
8
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 3 µg
Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 6.25 µg
Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 12.5 µg
Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 25 µg
Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 50 µg
Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
9
|
12
|
3
|
5
|
4
|
0
|
|
Overall Study
Protocol Violation
|
1
|
2
|
0
|
1
|
0
|
0
|
|
Overall Study
Met Protocol-defined Stopping Criteria
|
3
|
1
|
7
|
3
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy And Safety Of GW642444M Comparing Placebo In Adolescent And Adult Subjects With Persistent Asthma.
Baseline characteristics by cohort
| Measure |
Placebo
n=102 Participants
Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 3 µg
n=101 Participants
Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 6.25 µg
n=101 Participants
Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 12.5 µg
n=100 Participants
Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 25 µg
n=101 Participants
Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 50 µg
n=102 Participants
Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
Total
n=607 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
African American (AfAm)/African Heritage (AfH)
|
4 participants
n=93 Participants
|
11 participants
n=4 Participants
|
8 participants
n=27 Participants
|
12 participants
n=483 Participants
|
14 participants
n=36 Participants
|
8 participants
n=10 Participants
|
57 participants
n=115 Participants
|
|
Age, Continuous
|
39.9 Years
STANDARD_DEVIATION 15.60 • n=93 Participants
|
44.4 Years
STANDARD_DEVIATION 13.50 • n=4 Participants
|
42.4 Years
STANDARD_DEVIATION 14.13 • n=27 Participants
|
41.3 Years
STANDARD_DEVIATION 15.33 • n=483 Participants
|
42.2 Years
STANDARD_DEVIATION 14.27 • n=36 Participants
|
44.0 Years
STANDARD_DEVIATION 15.22 • n=10 Participants
|
42.4 Years
STANDARD_DEVIATION 14.72 • n=115 Participants
|
|
Gender
Female
|
61 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
56 Participants
n=483 Participants
|
61 Participants
n=36 Participants
|
57 Participants
n=10 Participants
|
338 Participants
n=115 Participants
|
|
Gender
Male
|
41 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
44 Participants
n=483 Participants
|
40 Participants
n=36 Participants
|
45 Participants
n=10 Participants
|
269 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
American Indian (AmIn) or Alaska Native (AN)
|
3 participants
n=93 Participants
|
2 participants
n=4 Participants
|
3 participants
n=27 Participants
|
2 participants
n=483 Participants
|
2 participants
n=36 Participants
|
1 participants
n=10 Participants
|
13 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Central/South Asian Heritage (Her)
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
0 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Japanese/East Asian (EA) Her/South EA Her
|
10 participants
n=93 Participants
|
13 participants
n=4 Participants
|
11 participants
n=27 Participants
|
8 participants
n=483 Participants
|
8 participants
n=36 Participants
|
9 participants
n=10 Participants
|
59 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
81 participants
n=93 Participants
|
74 participants
n=4 Participants
|
77 participants
n=27 Participants
|
75 participants
n=483 Participants
|
75 participants
n=36 Participants
|
83 participants
n=10 Participants
|
465 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
AfAm/AfH & AmIn or AN
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
AfAm/AfH & White
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
AmIn or AN & White
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
2 participants
n=483 Participants
|
1 participants
n=36 Participants
|
1 participants
n=10 Participants
|
6 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian & White
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 28Population: ITT Population: all participants who were randomized to treatment and received at least one dose of study medication. The LOCF method was used to impute missing data. When the endpoint was missing, the last valid non-missing on-treatment, post-Baseline trough assessment was used instead. Only measurements from scheduled visits were used.
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. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 28-day treatment period, with the trough FEV1 defined as the mean of the 23 hour and 24 hour post-dose assessments on Day 28. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) using LOCF with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, and treatment.
Outcome measures
| Measure |
Placebo
n=95 Participants
Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 3 µg
n=98 Participants
Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 6.25 µg
n=99 Participants
Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 12.5 µg
n=97 Participants
Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 25 µg
n=99 Participants
Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 50 µg
n=100 Participants
Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 (Last Observation Carried Forward [LOCF])
|
0.147 Liters
Standard Error 0.036
|
0.212 Liters
Standard Error 0.036
|
0.217 Liters
Standard Error 0.035
|
0.278 Liters
Standard Error 0.036
|
0.269 Liters
Standard Error 0.035
|
0.309 Liters
Standard Error 0.035
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: ITT Population. The LOCF method was used to impute missing data. When the endpoint was missing, the last valid non-missing on-treatment, post-Baseline trough assessment was used instead. Only measurements from scheduled visits were used. Only those participants with available data (using LOCF) at the indicated time point were analyzed.
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. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 28-day treatment period, with the trough FEV1 defined as the mean of the 23 hour and 24 hour post-dose assessments on Day 28. Change from Baseline in trough FEV1 at the end of the treatment period (23 hours and 24 hours after dosing on Day 28) was analyzed for each stratum (Lower stratum: FEV1 percent predicted, \>=40% to \<=65%; Upper stratum: FEV1 percent predicted, \>=65% to \<=90%). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA using LOCF with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, treatment, and treatment by stratum interaction.
Outcome measures
| Measure |
Placebo
n=95 Participants
Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 3 µg
n=98 Participants
Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 6.25 µg
n=99 Participants
Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 12.5 µg
n=97 Participants
Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 25 µg
n=99 Participants
Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 50 µg
n=100 Participants
Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 Per Stratum (LOCF)
Lower stratum, n=43, 44, 41, 40, 46, 45
|
0.210 Liters
Standard Error 0.057
|
0.161 Liters
Standard Error 0.056
|
0.247 Liters
Standard Error 0.057
|
0.319 Liters
Standard Error 0.057
|
0.281 Liters
Standard Error 0.054
|
0.349 Liters
Standard Error 0.055
|
|
Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 Per Stratum (LOCF)
Upper stratum, n=52, 54, 58, 57, 53, 55
|
0.098 Liters
Standard Error 0.049
|
0.254 Liters
Standard Error 0.051
|
0.194 Liters
Standard Error 0.048
|
0.247 Liters
Standard Error 0.049
|
0.259 Liters
Standard Error 0.049
|
0.276 Liters
Standard Error 0.049
|
SECONDARY outcome
Timeframe: Baseline; Day 1 and Day 28 (mean post-dose FEV1 after 15, 30, and 60 minutes and 2, 3, 4, 6, 12, 16, 20, 22, 23, and 24 hours)Population: ITT Population. Only those participants available at the indicated time points were analyzed.
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Change from Baseline in weighted mean for 24-hour serial FEV1 on Days 1 and Day 28 was assessed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, and treatment.
Outcome measures
| Measure |
Placebo
n=101 Participants
Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 3 µg
n=100 Participants
Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 6.25 µg
n=101 Participants
Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 12.5 µg
n=99 Participants
Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 25 µg
n=100 Participants
Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 50 µg
n=100 Participants
Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Weighted Mean 24-hour Serial FEV1 at Day 1 and Day 28
Day 28, n=87, 83, 91, 88, 93, 97
|
0.149 Liters
Standard Error 0.032
|
0.300 Liters
Standard Error 0.033
|
0.253 Liters
Standard Error 0.031
|
0.292 Liters
Standard Error 0.032
|
0.315 Liters
Standard Error 0.031
|
0.321 Liters
Standard Error 0.031
|
|
Change From Baseline in Weighted Mean 24-hour Serial FEV1 at Day 1 and Day 28
Day 1, n=101, 100, 101, 99, 100, 100
|
0.137 Liters
Standard Error 0.029
|
0.239 Liters
Standard Error 0.029
|
0.215 Liters
Standard Error 0.029
|
0.267 Liters
Standard Error 0.029
|
0.330 Liters
Standard Error 0.029
|
0.352 Liters
Standard Error 0.029
|
SECONDARY outcome
Timeframe: Baseline and Days 1-28Population: ITT Population. Only those participants available at the indicated time points were analyzed.
Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily PM over the 28-day treatment period (at Day 28) minus the Baseline value (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.
Outcome measures
| Measure |
Placebo
n=99 Participants
Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 3 µg
n=99 Participants
Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 6.25 µg
n=101 Participants
Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 12.5 µg
n=98 Participants
Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 25 µg
n=101 Participants
Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 50 µg
n=102 Participants
Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Trough (Pre-dose and Pre-bronchodilator) Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 28-day Treatment Period
|
0.4 Liters per minute
Standard Error 3.87
|
14.0 Liters per minute
Standard Error 3.87
|
24.5 Liters per minute
Standard Error 3.82
|
28.9 Liters per minute
Standard Error 3.87
|
34.0 Liters per minute
Standard Error 3.81
|
38.4 Liters per minute
Standard Error 3.82
|
SECONDARY outcome
Timeframe: Baseline and Days 1-28Population: ITT Population. Only those participants available at the indicated time points were analyzed.
Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily AM over the 28-day treatment period (at Day 28) minus the Baseline value (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.
Outcome measures
| Measure |
Placebo
n=98 Participants
Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 3 µg
n=99 Participants
Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 6.25 µg
n=101 Participants
Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 12.5 µg
n=98 Participants
Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 25 µg
n=101 Participants
Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 50 µg
n=102 Participants
Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 28-day Treatment Period
|
1.9 Liters per minute
Standard Error 3.69
|
18.7 Liters per minute
Standard Error 3.67
|
26.8 Liters per minute
Standard Error 3.63
|
34.2 Liters per minute
Standard Error 3.68
|
38.1 Liters per minute
Standard Error 3.61
|
44.0 Liters per minute
Standard Error 3.63
|
SECONDARY outcome
Timeframe: Baseline and Days 1-28Population: ITT Population. Only those participants available at the indicated time points were analyzed.
Participants who were symptom free for 24 hours were assessed. Change from Baseline was calculated as the value at Day 28 minus the value at Baseline (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.
Outcome measures
| Measure |
Placebo
n=98 Participants
Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 3 µg
n=99 Participants
Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 6.25 µg
n=101 Participants
Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 12.5 µg
n=98 Participants
Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 25 µg
n=101 Participants
Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 50 µg
n=102 Participants
Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Averaged Over the 28-day Treatment Period
|
14.2 Percentage of symptom-free 24-hr periods
Standard Error 3.27
|
22.6 Percentage of symptom-free 24-hr periods
Standard Error 3.25
|
23.6 Percentage of symptom-free 24-hr periods
Standard Error 3.21
|
26.8 Percentage of symptom-free 24-hr periods
Standard Error 3.26
|
36.4 Percentage of symptom-free 24-hr periods
Standard Error 3.21
|
32.3 Percentage of symptom-free 24-hr periods
Standard Error 3.21
|
SECONDARY outcome
Timeframe: Baseline and Days 1-28Population: ITT Population. Only those participants available at the indicated time points were analyzed.
The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. Change from Baseline is calculated as the value at Day 28 minus the value at Baseline (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.
Outcome measures
| Measure |
Placebo
n=99 Participants
Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 3 µg
n=99 Participants
Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 6.25 µg
n=101 Participants
Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 12.5 µg
n=98 Participants
Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 25 µg
n=101 Participants
Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 50 µg
n=102 Participants
Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Averaged Over the 28-day Treatment Period
|
15.0 Percentage of rescue-free 24-hr periods
Standard Error 3.33
|
25.8 Percentage of rescue-free 24-hr periods
Standard Error 3.33
|
27.3 Percentage of rescue-free 24-hr periods
Standard Error 3.28
|
29.6 Percentage of rescue-free 24-hr periods
Standard Error 3.34
|
43.4 Percentage of rescue-free 24-hr periods
Standard Error 3.28
|
34.0 Percentage of rescue-free 24-hr periods
Standard Error 3.28
|
SECONDARY outcome
Timeframe: 24 hours after dosing on Day 1 (Visit 2) and on Day 28 (Visit 5)Population: ITT Population. Only those participants available at the indicated time points were analyzed.
Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, \>=6 hours after the last use of salbutamol/albuterol, \>=6 hours after the last caffeine consumption, \>=2 hours after exercise (or strenuous activity), \>=24 hours after the first dose (Visit 2) or last dose (Visit 5) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.
Outcome measures
| Measure |
Placebo
n=83 Participants
Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 3 µg
n=80 Participants
Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 6.25 µg
n=87 Participants
Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 12.5 µg
n=86 Participants
Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 25 µg
n=86 Participants
Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 50 µg
n=92 Participants
Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
|---|---|---|---|---|---|---|
|
Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30 Minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: 24 Hours After Dosing on Day 1 and Day 28
|
-0.039 Liters
Standard Error 0.023
|
-0.035 Liters
Standard Error 0.024
|
-0.012 Liters
Standard Error 0.023
|
-0.017 Liters
Standard Error 0.023
|
-0.062 Liters
Standard Error 0.023
|
-0.049 Liters
Standard Error 0.022
|
SECONDARY outcome
Timeframe: Screening (Visit 1) and 24 hours after dosing on Day 1 (Visit 2)Population: ITT Population. Only those participants available at the indicated time points were analyzed.
Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, \>=6 hours after the last use of salbutamol/albuterol, \>=6 hours after the last caffeine consumption, \>=2 hours after exercise (or strenuous activity), Screening and \>=24 hours after the first dose (Visit 2) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.
Outcome measures
| Measure |
Placebo
n=97 Participants
Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 3 µg
n=97 Participants
Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 6.25 µg
n=98 Participants
Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 12.5 µg
n=99 Participants
Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 25 µg
n=96 Participants
Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 50 µg
n=98 Participants
Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
|---|---|---|---|---|---|---|
|
Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: Screening and 24 Hours After Dosing on Day 1
|
-0.040 Liters
Standard Error 0.028
|
0.008 Liters
Standard Error 0.028
|
-0.061 Liters
Standard Error 0.028
|
-0.029 Liters
Standard Error 0.028
|
-0.020 Liters
Standard Error 0.028
|
-0.060 Liters
Standard Error 0.028
|
SECONDARY outcome
Timeframe: Screening (Visit 1) and 24 hours after dosing on Day 28 (Visit 5)Population: ITT Population. Only those participants available at the indicated time points were analyzed.
Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, \>=6 hours after the last use of salbutamol/albuterol, \>=6 hours after the last caffeine consumption, \>=2 hours after exercise (or strenuous activity), Screening and \>=24 hours after the first dose (Visit 2) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.
Outcome measures
| Measure |
Placebo
n=84 Participants
Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 3 µg
n=80 Participants
Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 6.25 µg
n=89 Participants
Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 12.5 µg
n=86 Participants
Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 25 µg
n=88 Participants
Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 50 µg
n=93 Participants
Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
|---|---|---|---|---|---|---|
|
Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30 Minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: Screening and 24 Hours After Dosing on Day 28
|
-0.076 Liters
Standard Error 0.031
|
-0.022 Liters
Standard Error 0.031
|
-0.055 Liters
Standard Error 0.030
|
-0.048 Liters
Standard Error 0.030
|
-0.086 Liters
Standard Error 0.030
|
-0.104 Liters
Standard Error 0.029
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
GW642444M 3 µg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
GW642444M 6.25 µg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
GW642444M 12.5 µg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
GW642444M 25 µg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
GW642444M 50 µg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=102 participants at risk
Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 3 µg
n=101 participants at risk
Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 6.25 µg
n=101 participants at risk
Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 12.5 µg
n=100 participants at risk
Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 25 µg
n=101 participants at risk
Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
GW642444M 50 µg
n=102 participants at risk
Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
7.8%
8/102 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to Day 28), are reported.
Serious adverse events (SAEs) and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
11.9%
12/101 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to Day 28), are reported.
Serious adverse events (SAEs) and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
6.9%
7/101 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to Day 28), are reported.
Serious adverse events (SAEs) and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
9.0%
9/100 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to Day 28), are reported.
Serious adverse events (SAEs) and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
6.9%
7/101 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to Day 28), are reported.
Serious adverse events (SAEs) and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
7.8%
8/102 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to Day 28), are reported.
Serious adverse events (SAEs) and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
2/102 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to Day 28), are reported.
Serious adverse events (SAEs) and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
2.0%
2/101 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to Day 28), are reported.
Serious adverse events (SAEs) and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.99%
1/101 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to Day 28), are reported.
Serious adverse events (SAEs) and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
3.0%
3/100 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to Day 28), are reported.
Serious adverse events (SAEs) and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
2.0%
2/101 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to Day 28), are reported.
Serious adverse events (SAEs) and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
2.0%
2/102 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to Day 28), are reported.
Serious adverse events (SAEs) and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
4/102 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to Day 28), are reported.
Serious adverse events (SAEs) and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
2.0%
2/101 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to Day 28), are reported.
Serious adverse events (SAEs) and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
2.0%
2/101 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to Day 28), are reported.
Serious adverse events (SAEs) and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/100 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to Day 28), are reported.
Serious adverse events (SAEs) and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/101 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to Day 28), are reported.
Serious adverse events (SAEs) and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
2.0%
2/102 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to Day 28), are reported.
Serious adverse events (SAEs) and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
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