Trial Outcomes & Findings for Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma (NCT NCT01181895)
NCT ID: NCT01181895
Last Updated: 2017-11-08
Results Overview
FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, at Week 12. The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline is calculated as the weighted mean 0-24 hour FEV1 (Liters) at Week 12 minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
348 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2017-11-08
Participant Flow
347 participants (par.) were randomized to treatment; all 347 were included in the Intent-to-Treat (ITT) Population. One par. was not randomized but received treatment in error. This par. was not included in the ITT Population and is thus not captured in the Participant Flow module. This par. is categorized as being enrolled in the study (n=348).
Participants (par.) meeting eligibility criteria at the Screening visit completed a 28-day Run-in Period for Baseline, safety evaluations, and measures of asthma status. Par. were then randomized to an 8-week Treatment Period. A total of 583 par. were screened, and 347 were randomized, of which 298 received at least one dose of study treatment.
Participant milestones
| Measure |
Placebo
Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
Vilanteral 25 µg OD
Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
Salmeterol 50 µg BID
Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
116
|
115
|
116
|
|
Overall Study
COMPLETED
|
99
|
101
|
98
|
|
Overall Study
NOT COMPLETED
|
17
|
14
|
18
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
Vilanteral 25 µg OD
Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
Salmeterol 50 µg BID
Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
8
|
9
|
9
|
|
Overall Study
Protocol Violation
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
2
|
|
Overall Study
Investigator Discretion
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
5
|
Baseline Characteristics
Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma
Baseline characteristics by cohort
| Measure |
Placebo
n=116 Participants
Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
Vilanteral 25 µg OD
n=115 Participants
Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
Salmeterol 50 µg BID
n=116 Participants
Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
Total
n=347 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.7 Years
STANDARD_DEVIATION 16.64 • n=5 Participants
|
41.0 Years
STANDARD_DEVIATION 17.81 • n=7 Participants
|
41.1 Years
STANDARD_DEVIATION 16.84 • n=5 Participants
|
41.3 Years
STANDARD_DEVIATION 17.06 • n=4 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
204 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
37 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Japanese/East Asian Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
68 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
202 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants available at the indicated time point were assessed.
FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, at Week 12. The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline is calculated as the weighted mean 0-24 hour FEV1 (Liters) at Week 12 minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.
Outcome measures
| Measure |
Placebo
n=95 Participants
Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
Vilanteral 25 µg OD
n=101 Participants
Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
Salmeterol 50 µg BID
n=100 Participants
Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|
|
Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12
|
0.289 Liters
Standard Error 0.0429
|
0.359 Liters
Standard Error 0.0416
|
0.283 Liters
Standard Error 0.0419
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-12Population: ITT Population. Only those participants available at the indicated time points were assessed.
The time span during which the participants did not have to take any rescue bronchodilator (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Outcome measures
| Measure |
Placebo
n=115 Participants
Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
Vilanteral 25 µg OD
n=115 Participants
Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
Salmeterol 50 µg BID
n=114 Participants
Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|
|
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period
|
14.6 Percentage of rescue-free 24-hr periods
Standard Error 2.71
|
21.7 Percentage of rescue-free 24-hr periods
Standard Error 2.68
|
22.9 Percentage of rescue-free 24-hr periods
Standard Error 2.72
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-12Population: ITT Population. Only those participants available at the indicated time points were assessed.
Participants who were symptom free for 24-hour periods during the12-week treatment period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Outcome measures
| Measure |
Placebo
n=115 Participants
Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
Vilanteral 25 µg OD
n=115 Participants
Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
Salmeterol 50 µg BID
n=114 Participants
Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|
|
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period
|
12.7 Percentage of symptom-free 24-hr periods
Standard Error 2.58
|
19.4 Percentage of symptom-free 24-hr periods
Standard Error 2.55
|
19.5 Percentage of symptom-free 24-hr periods
Standard Error 2.59
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT Population. Only those participants available at the indicated time points were assessed.
FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The individual serial FEV1 is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 3, 5, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, relatively, on Treatment Day 84 (Week 12). The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline was calculated as the value of the individual serial FEV1 taken at Week 12 minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment. Analysis was performed separately for each planned time point.
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
Vilanteral 25 µg OD
n=115 Participants
Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
Salmeterol 50 µg BID
n=116 Participants
Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
Predose, n=97,104,101
|
0.302 Liters
Standard Error 0.0446
|
0.272 Liters
Standard Error 0.0430
|
0.233 Liters
Standard Error 0.0437
|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
5 min, n=95,100,98
|
0.313 Liters
Standard Error 0.0450
|
0.301 Liters
Standard Error 0.0438
|
0.214 Liters
Standard Error 0.0443
|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
15 min, n=96, 101, 99
|
0.308 Liters
Standard Error 0.0450
|
0.324 Liters
Standard Error 0.0439
|
0.257 Liters
Standard Error 0.0444
|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
30 min, n=,96,101,100
|
0.322 Liters
Standard Error 0.0443
|
0.344 Liters
Standard Error 0.0432
|
0.272 Liters
Standard Error 0.0435
|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
60 min, n=96, 101, 100
|
0.336 Liters
Standard Error 0.0445
|
0.352 Liters
Standard Error 0.0433
|
0.296 Liters
Standard Error 0.0437
|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
2 hours, n=96, 100, 99
|
0.313 Liters
Standard Error 0.0455
|
0.369 Liters
Standard Error 0.0446
|
0.335 Liters
Standard Error 0.0449
|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
3 hours, n=96, 101, 100
|
0.304 Liters
Standard Error 0.0455
|
0.374 Liters
Standard Error 0.0444
|
0.316 Liters
Standard Error 0.0447
|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
4 hours, n=96, 101, 100
|
0.311 Liters
Standard Error 0.0450
|
0.359 Liters
Standard Error 0.0438
|
0.293 Liters
Standard Error 0.0441
|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
5 hours, n=96, 100, 100
|
0.292 Liters
Standard Error 0.0455
|
0.368 Liters
Standard Error 0.0445
|
0.279 Liters
Standard Error 0.0447
|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
11 hours, n=94, 99, 96
|
0.195 Liters
Standard Error 0.0508
|
0.312 Liters
Standard Error 0.0494
|
0.179 Liters
Standard Error 0.0505
|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
12 hours, n=93,98,95
|
0.250 Liters
Standard Error 0.0477
|
0.341 Liters
Standard Error 0.0465
|
0.217 Liters
Standard Error 0.0473
|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
12.5 hours, n=96, 97, 98
|
0.270 Liters
Standard Error 0.0446
|
0.337 Liters
Standard Error 0.0444
|
0.282 Liters
Standard Error 0.0443
|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
13 hours, 96, 98, 100
|
0.312 Liters
Standard Error 0.0448
|
0.341 Liters
Standard Error 0.0442
|
0.304 Liters
Standard Error 0.0440
|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
14 hours, n=95, 99, 99
|
0.341 Liters
Standard Error 0.0445
|
0.401 Liters
Standard Error 0.0436
|
0.359 Liters
Standard Error 0.0437
|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
16 hours, n=95, 98, 97
|
0.364 Liters
Standard Error 0.0464
|
0.371 Liters
Standard Error 0.0457
|
0.357 Liters
Standard Error 0.0461
|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
20 hours, n= 94, 101, 99
|
0.318 Liters
Standard Error 0.0485
|
0.371 Liters
Standard Error 0.0467
|
0.296 Liters
Standard Error 0.0473
|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
23 hours, 94, 101, 99
|
0.310 Liters
Standard Error 0.0456
|
0.345 Liters
Standard Error 0.0440
|
0.271 Liters
Standard Error 0.0446
|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
24 hours, n= 95, 101, 100
|
0.301 Liters
Standard Error 0.0445
|
0.330 Liters
Standard Error 0.0432
|
0.275 Liters
Standard Error 0.0435
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-12Population: ITT Population. Only those participants available at the indicated time points were assessed.
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily PM PEF prior to randomization. Change from Baseline in trough PM PEF was calculated as the averaged value of all daily PM PEF for Week 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Outcome measures
| Measure |
Placebo
n=115 Participants
Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
Vilanteral 25 µg OD
n=115 Participants
Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
Salmeterol 50 µg BID
n=114 Participants
Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|
|
Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) PM (Evening) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period
|
11.0 Liters per minute (L/min)
Standard Error 3.15
|
24.9 Liters per minute (L/min)
Standard Error 3.14
|
18.8 Liters per minute (L/min)
Standard Error 3.17
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-12Population: ITT Population. Only those participants available at the indicated time points were assessed.
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily AM PEF prior to randomization. Change from Baseline in trough AM PEF was calculated as the averaged value of all daily AM PEF for Weeks 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Outcome measures
| Measure |
Placebo
n=115 Participants
Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
Vilanteral 25 µg OD
n=115 Participants
Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
Salmeterol 50 µg BID
n=114 Participants
Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|
|
Change From Baseline in Daily AM (Morning) PEF Averaged Over the 12-week Treatment Period
|
14.2 Liters per minute (L/min)
Standard Error 3.25
|
28.0 Liters per minute (L/min)
Standard Error 3.24
|
23.6 Liters per minute (L/min)
Standard Error 3.27
|
SECONDARY outcome
Timeframe: Day 1 and Week 12Population: ITT Population. Only those participants available at the indicated time points were assessed.
The number of participants with a \>=12% and \>=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated on Day 1 and Week 12 for the time to a \>=12% increase from Baseline (at the 5 minutes (min), 15 min, 30 min, 1hour (hr), and 2 hr nominal time points. Participants who did not achieve a \>=12% and \>=200 mL increase from Baseline in FEV1 over this time period were considered censored.
Outcome measures
| Measure |
Placebo
n=113 Participants
Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
Vilanteral 25 µg OD
n=115 Participants
Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
Salmeterol 50 µg BID
n=116 Participants
Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|
|
Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)
Day 1, 5 min, n=113, 115, 116
|
23 Participants
|
33 Participants
|
18 Participants
|
|
Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)
Day 1, 15 min, n=113, 115, 116
|
2 Participants
|
11 Participants
|
11 Participants
|
|
Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)
Day 1, 30 min, n=113, 115, 1116
|
3 Participants
|
8 Participants
|
13 Participants
|
|
Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)
Day 1, 1 hr, n=113, 115, 116
|
3 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)
Day 1, 2 hr, n=113, 115, 116
|
5 Participants
|
6 Participants
|
11 Participants
|
|
Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)
Day 1, Censored, n=113, 115, 116
|
77 Participants
|
50 Participants
|
57 Participants
|
|
Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)
Week 12, 5 min, n=96, 101, 100
|
39 Participants
|
42 Participants
|
30 Participants
|
|
Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)
Week 12, 15 min, n=96, 101, 100
|
6 Participants
|
2 Participants
|
7 Participants
|
|
Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)
Week 12, 30 min, n=96, 101, 100
|
2 Participants
|
2 Participants
|
8 Participants
|
|
Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)
Week 12, 1 hr, n=96, 101, 100
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)
Week 12, 2 hr, n=96, 101, 100
|
3 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)
Week 12, Censored, n=96, 101, 100
|
45 Participants
|
44 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Week 4 and Week 12Population: ITT Population. Only those participants available at the indicated time points were assessed.
At the end of Week 4 and Week 12, the Global Assessment of Change Questionnaire, which assesses changes in asthma symptoms and rescue medication use, was completed by participants using the following scale: asthma symptom (AS) change: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse; rescue medication use (RMU): much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often.
Outcome measures
| Measure |
Placebo
n=110 Participants
Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
Vilanteral 25 µg OD
n=109 Participants
Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
Salmeterol 50 µg BID
n=110 Participants
Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 12, RMU: Much more often, n=100, 105, 101
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 4, AS: Much better, n=110, 109, 110
|
25 Participants
|
37 Participants
|
34 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 4, AS: Somewhat better, n=110, 109, 110
|
35 Participants
|
43 Participants
|
34 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 4, AS: A little better, n=110, 109, 110
|
24 Participants
|
14 Participants
|
21 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 4, AS: The same, n=110, 109, 110
|
17 Participants
|
13 Participants
|
16 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 4, AS: A little worse, n=110, 109, 110
|
6 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 4, AS: Somewhat worse, n=110, 109, 110
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 4, AS: Much worse, n=110, 109, 110
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 4, RMU: Much less often, n=110, 109, 110
|
18 Participants
|
33 Participants
|
28 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 4, RMU: Somewhat less often, n=110, 109, 110
|
40 Participants
|
31 Participants
|
36 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 4, RMU: A little less often, n=110, 109, 110
|
18 Participants
|
23 Participants
|
20 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 4, RMU: The same, n=110, 109, 110
|
26 Participants
|
18 Participants
|
17 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 4, RMU: A little more often, n=110, 109, 110
|
4 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 4, RMU: Somewhat more often, n=110, 109, 110
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 4, RMU: Much more often, n=110, 109, 110
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 12, AS: Much better, n=100, 105, 101
|
31 Participants
|
52 Participants
|
35 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 12, AS: Somewhat better, n=100, 105, 101
|
35 Participants
|
31 Participants
|
34 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 12, AS: A little better, n=100, 105, 101
|
13 Participants
|
9 Participants
|
16 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 12, AS: The same, n=100, 105, 101
|
12 Participants
|
9 Participants
|
11 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 12, AS: A little worse, n=100, 105, 101
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 12, AS: Somewhat worse, n=100, 105, 101
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 12, AS: Much worse, n=100, 105, 101
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 12, RMU: Much less often, n=100, 105, 101
|
25 Participants
|
40 Participants
|
32 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 12, RMU: Somewhat less often, n=100, 105, 101
|
31 Participants
|
32 Participants
|
29 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 12, RMU: A little less often, n=100, 105, 101
|
13 Participants
|
16 Participants
|
13 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 12, RMU: The same, n=100, 105, 101
|
23 Participants
|
11 Participants
|
21 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 12, RMU: A little more often, n=100, 105, 101
|
2 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Week 12, RMU: Somewhat more often, n=100, 105, 101
|
4 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Vilanteral 25 µg OD
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Salmeterol 50 µg BID
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=116 participants at risk
Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
Vilanteral 25 µg OD
n=115 participants at risk
Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
Salmeterol 50 µg BID
n=116 participants at risk
Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|
|
General disorders
Sudden death
|
0.86%
1/116
|
0.00%
0/115
|
0.00%
0/116
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/116
|
0.87%
1/115
|
0.00%
0/116
|
Other adverse events
| Measure |
Placebo
n=116 participants at risk
Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
|
Vilanteral 25 µg OD
n=115 participants at risk
Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
Salmeterol 50 µg BID
n=116 participants at risk
Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
10.3%
12/116
|
7.8%
9/115
|
6.0%
7/116
|
|
Infections and infestations
Upper respiratory tract infection
|
6.9%
8/116
|
1.7%
2/115
|
1.7%
2/116
|
|
Nervous system disorders
Headache
|
4.3%
5/116
|
8.7%
10/115
|
7.8%
9/116
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.0%
7/116
|
5.2%
6/115
|
1.7%
2/116
|
|
General disorders
Pyrexia
|
0.00%
0/116
|
3.5%
4/115
|
0.86%
1/116
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/116
|
0.00%
0/115
|
4.3%
5/116
|
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