Trial Outcomes & Findings for Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children (NCT NCT01573767)
NCT ID: NCT01573767
Last Updated: 2017-01-09
Results Overview
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use each morning. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 4-week Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Phase. The analysis was performed using an analysis of covariance (ANCOVA) model with covariates of Baseline, region, sex, age, and treatment. Only those participants contributing data per the daily eDiary were analyzed.
COMPLETED
PHASE2
463 participants
Baseline; Week 1 up to Week 4
2017-01-09
Participant Flow
1208 participants (par.) were screened; 760 entered the Run-in Phase, 463 were randomized, and 2 received study medication (SM) but weren't randomized/included in the Intent-to-Treat (ITT) Population (randomized to treatment and receiving \>=1 SM dose). 7 randomized par. didn't receive SM; hence, 456 par. comprised the ITT Population.
Participants who met the eligibility criteria at screening (Visit 1) entered the Run-in Phase for completion of Baseline safety evaluations and measures of asthma status. Participants meeting all randomization criteria at Visit 3 were randomized to 1 of 4 treatment arms. The total duration of study participation was up to a maximum of 9 weeks.
Participant milestones
| Measure |
Placebo
Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 6.25 µg OD
Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 12.5 µg OD
Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 25 µg OD
Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
115
|
114
|
113
|
114
|
|
Overall Study
COMPLETED
|
93
|
93
|
99
|
90
|
|
Overall Study
NOT COMPLETED
|
22
|
21
|
14
|
24
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 6.25 µg OD
Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 12.5 µg OD
Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 25 µg OD
Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
18
|
15
|
12
|
17
|
|
Overall Study
Protocol Violation
|
3
|
1
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
2
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children
Baseline characteristics by cohort
| Measure |
Placebo
n=115 Participants
Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 6.25 µg OD
n=114 Participants
Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 12.5 µg OD
n=113 Participants
Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 25 µg OD
n=114 Participants
Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
Total
n=456 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
8.0 Years
STANDARD_DEVIATION 1.81 • n=5 Participants
|
8.0 Years
STANDARD_DEVIATION 1.95 • n=7 Participants
|
7.9 Years
STANDARD_DEVIATION 1.74 • n=5 Participants
|
7.9 Years
STANDARD_DEVIATION 1.72 • n=4 Participants
|
7.9 Years
STANDARD_DEVIATION 1.80 • n=21 Participants
|
|
Gender
Female
|
50 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
180 Participants
n=21 Participants
|
|
Gender
Male
|
65 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
276 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
67 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
245 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 1 up to Week 4Population: ITT Population: participants randomized to treatment who received \>=1 dose of study medication
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use each morning. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 4-week Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Phase. The analysis was performed using an analysis of covariance (ANCOVA) model with covariates of Baseline, region, sex, age, and treatment. Only those participants contributing data per the daily eDiary were analyzed.
Outcome measures
| Measure |
Placebo
n=113 Participants
Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 6.25 µg OD
n=113 Participants
Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 12.5 µg OD
n=112 Participants
Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 25 µg OD
n=110 Participants
Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
|---|---|---|---|---|
|
Change From Baseline in Daily Pre-dose Evening (PM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 4-week Treatment Period
|
215.9 Liters per minute (L/min)
Standard Error 2.53
|
221.4 Liters per minute (L/min)
Standard Error 2.53
|
222.4 Liters per minute (L/min)
Standard Error 2.54
|
220.3 Liters per minute (L/min)
Standard Error 2.56
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: ITT Population. Only those participants available at the specified 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. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on treatment. Change from Baseline in trough FEV1 at the end of the 4-week Treatment Period was defined using the pre-dose FEV1 measurement taken at the Week 4 clinic visit. Change from Baseline was calculated as the Week 4 trough FEV1 value minus the Baseline value. The Baseline FEV1 value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.
Outcome measures
| Measure |
Placebo
n=85 Participants
Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 6.25 µg OD
n=83 Participants
Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 12.5 µg OD
n=86 Participants
Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 25 µg OD
n=86 Participants
Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
|---|---|---|---|---|
|
Change From Baseline in Evening Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 4-week Treatment Period in Children Who Could Perform the Maneuver
|
0.223 Liters
Standard Error 0.0287
|
0.166 Liters
Standard Error 0.0292
|
0.240 Liters
Standard Error 0.0285
|
0.193 Liters
Standard Error 0.0288
|
SECONDARY outcome
Timeframe: Baseline; Week 1 up to Week 4Population: ITT population. Only those participants available at the specified time points were analyzed.
The number of inhalations of rescue albuterol/salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night) was recorded by the participants in a daily diary. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 4-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. Change from Baseline is calculated as the average value during the 4-week Treatment Period minus the value at Baseline. The Baseline value is defined as the value at Visit 3 (randomization). Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Outcome measures
| Measure |
Placebo
n=113 Participants
Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 6.25 µg OD
n=113 Participants
Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 12.5 µg OD
n=112 Participants
Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 25 µg OD
n=110 Participants
Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
|---|---|---|---|---|
|
Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 4-week Treatment Period
|
14.4 Percentage of rescue-free 24-hr periods
Standard Error 2.97
|
12.2 Percentage of rescue-free 24-hr periods
Standard Error 2.97
|
15.8 Percentage of rescue-free 24-hr periods
Standard Error 2.98
|
2.98 Percentage of rescue-free 24-hr periods
Standard Error 3.01
|
SECONDARY outcome
Timeframe: Baseline; Week 1 up to Week 4Population: ITT Population. Only those participants available at the specified time points were analyzed.
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 4-week Treatment Period (at Week 4) minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.
Outcome measures
| Measure |
Placebo
n=114 Participants
Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 6.25 µg OD
n=113 Participants
Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 12.5 µg OD
n=112 Participants
Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 25 µg OD
n=110 Participants
Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
|---|---|---|---|---|
|
Change From Baseline in Daily Morning (AM) PEF Averaged Over the 4-week Treatment Period
|
6.4 L/min
Standard Error 2.42
|
12.0 L/min
Standard Error 2.43
|
13.9 L/min
Standard Error 2.44
|
13.7 L/min
Standard Error 2.46
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: ITT Population. Only those participants available at the specified time points were analyzed.
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline is calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.
Outcome measures
| Measure |
Placebo
n=113 Participants
Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 6.25 µg OD
n=113 Participants
Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 12.5 µg OD
n=112 Participants
Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 25 µg OD
n=110 Participants
Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
|---|---|---|---|---|
|
Change From Baseline in Evening (PM) PEF Over the Last 7 Days of the Treatment Period (Week 4)
|
5.9 L/min
Standard Error 3.44
|
9.4 L/min
Standard Error 3.44
|
13.7 L/min
Standard Error 3.45
|
11.1 L/min
Standard Error 3.48
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: ITT Population. Only those participants available at the specified time points were analyzed.
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline is calculated as the value of the averaged daily AM PEF over the 4-week Treatment Period (at Week 4) minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.
Outcome measures
| Measure |
Placebo
n=114 Participants
Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 6.25 µg OD
n=113 Participants
Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 12.5 µg OD
n=112 Participants
Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 25 µg OD
n=110 Participants
Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
|---|---|---|---|---|
|
Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 4)
|
7.4 L/min
Standard Error 3.45
|
13.3 L/min
Standard Error 3.47
|
17.0 L/min
Standard Error 3.48
|
14.4 L/min
Standard Error 3.51
|
SECONDARY outcome
Timeframe: Baseline; Week 1 up to Week 4Population: ITT Population. Only those participants available at the specified time points were analyzed.
Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline symptom-free value is defined as the value at Visit 3 (randomization). Change from Baseline was calculated as the averaged value during the 4-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.
Outcome measures
| Measure |
Placebo
n=113 Participants
Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 6.25 µg OD
n=113 Participants
Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 12.5 µg OD
n=112 Participants
Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 25 µg OD
n=110 Participants
Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
|---|---|---|---|---|
|
Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the 4-week Treatment Period
|
9.9 Percentage of symptom-free 24-hr periods
Standard Error 2.65
|
10.1 Percentage of symptom-free 24-hr periods
Standard Error 2.65
|
18.3 Percentage of symptom-free 24-hr periods
Standard Error 2.66
|
19.7 Percentage of symptom-free 24-hr periods
Standard Error 2.69
|
Adverse Events
Placebo
VI 6.25 OD
VI 12.5 OD
VI 25 OD
Serious adverse events
| Measure |
Placebo
n=115 participants at risk
Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 6.25 OD
n=114 participants at risk
Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 12.5 OD
n=113 participants at risk
Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 25 OD
n=114 participants at risk
Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/115 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 9 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.00%
0/114 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 9 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.00%
0/113 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 9 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.88%
1/114 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 9 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
Other adverse events
| Measure |
Placebo
n=115 participants at risk
Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 6.25 OD
n=114 participants at risk
Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 12.5 OD
n=113 participants at risk
Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
VI 25 OD
n=114 participants at risk
Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.0%
8/115 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 9 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
7.0%
8/114 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 9 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
8.8%
10/113 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 9 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
7.9%
9/114 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 9 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
0.00%
0/115 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 9 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
3.5%
4/114 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 9 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.00%
0/113 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 9 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.00%
0/114 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 9 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
3.5%
4/115 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 9 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
5.3%
6/114 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 9 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
1.8%
2/113 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 9 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
1.8%
2/114 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 9 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
Additional Information
GSK Response Center
GlaxoSmithKline
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