Trial Outcomes & Findings for A Non-inferiority Study to Evaluate the Efficacy, Safety, and Tolerability of Combination Dry Powder of Fluticasone Propionate and Salmeterol (FSC) 250/50 Microgram (mcg) Twice Daily (BID) in Adults and Adolescents With Asthma (NCT NCT01978119)
NCT ID: NCT01978119
Last Updated: 2017-05-25
Results Overview
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The trough FEV1 is defined as morning prebronchodilator and predose (12 hours after the last evening dose Day 84). Trough FEV1 was measured electronically by spirometer in the morning, before using the bronchodilator and predose, at Week 12 (Day 85) of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on day 1 in each treatment period. Change from Baseline within each period was calculated as trough FEV1 at Day 85 minus the period specific Baseline value. The change from Baseline in trough FEV1 was analysed using Mixed Model for Repeated Measures analysis, having fixed effect Participant level Baseline, Adjusted period-specific Baseline, Treatment group, Period, Visit, Visit by treatment, Visit by Participant level Baseline, Visit by Adjusted period-specific Baseline, with participant as a random effect.
COMPLETED
PHASE3
124 participants
Baseline and Day 85
2017-05-25
Participant Flow
Total 124 participants (par) were enrolled into the study, 33 participants were screen failures and 7 participants were run-in failures. A total of 84 participants were randomised and 82 participants were included in Intend to treat (ITT) population.
Participant milestones
| Measure |
Sequence 1: Pl MD-DPI/FSC CB-DPI Then FSC MD-DPI/Pl CB-DPI
Participants self administered one inhalation of matching Placebo (Pl) via a multi-dose dry powder inhaler (MD DPI) and one inhalation of single capsule containing Fluticasone salmeterol combination (FSC) (250/50 microgram \[mcg\]) via a capsule-based unit dose (CB) DPI in the morning and evening in the Treatment Period 1 for 12 weeks. After washout period of 3 weeks participants self administered one inhalation of FSC (250/50 mcg) via the multi-dose DPI and one inhalation of of matching Placebo via the capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
Sequence 2: FSC MD-DPI/Pl CB-DPI Then Pl MD-DPI/FSC CB-DPI
Participants self administered one inhalation of FSC (250/50 mcg) via a multi-dose DPI and one inhalation of Placebo via a capsule-based unit dose DPI in the morning and evening in Treatment Period 1 for 12 weeks. After washout period of 3 weeks participants self admnistered one inhalation of matching Placebo via a multi-dose DPI and one inhalation of FSC (250/50 mcg) via a capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
|---|---|---|
|
Treatment Period 1 (12 Weeks)
STARTED
|
40
|
42
|
|
Treatment Period 1 (12 Weeks)
COMPLETED
|
38
|
42
|
|
Treatment Period 1 (12 Weeks)
NOT COMPLETED
|
2
|
0
|
|
Washout Period 1 (3 Weeks)
STARTED
|
38
|
42
|
|
Washout Period 1 (3 Weeks)
COMPLETED
|
38
|
42
|
|
Washout Period 1 (3 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2 (12 Weeks)
STARTED
|
38
|
42
|
|
Treatment Period 2 (12 Weeks)
COMPLETED
|
38
|
40
|
|
Treatment Period 2 (12 Weeks)
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Sequence 1: Pl MD-DPI/FSC CB-DPI Then FSC MD-DPI/Pl CB-DPI
Participants self administered one inhalation of matching Placebo (Pl) via a multi-dose dry powder inhaler (MD DPI) and one inhalation of single capsule containing Fluticasone salmeterol combination (FSC) (250/50 microgram \[mcg\]) via a capsule-based unit dose (CB) DPI in the morning and evening in the Treatment Period 1 for 12 weeks. After washout period of 3 weeks participants self administered one inhalation of FSC (250/50 mcg) via the multi-dose DPI and one inhalation of of matching Placebo via the capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
Sequence 2: FSC MD-DPI/Pl CB-DPI Then Pl MD-DPI/FSC CB-DPI
Participants self administered one inhalation of FSC (250/50 mcg) via a multi-dose DPI and one inhalation of Placebo via a capsule-based unit dose DPI in the morning and evening in Treatment Period 1 for 12 weeks. After washout period of 3 weeks participants self admnistered one inhalation of matching Placebo via a multi-dose DPI and one inhalation of FSC (250/50 mcg) via a capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
|---|---|---|
|
Treatment Period 1 (12 Weeks)
Participants reached stopping criteria
|
1
|
0
|
|
Treatment Period 1 (12 Weeks)
Withdrawal by Subject
|
1
|
0
|
|
Treatment Period 2 (12 Weeks)
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
A Non-inferiority Study to Evaluate the Efficacy, Safety, and Tolerability of Combination Dry Powder of Fluticasone Propionate and Salmeterol (FSC) 250/50 Microgram (mcg) Twice Daily (BID) in Adults and Adolescents With Asthma
Baseline characteristics by cohort
| Measure |
Overall Study
n=82 Participants
All participants received one of the following 2 treatments in each of the two 12-week treatment periods separated by a 3-week washout period. One actuations of FSC (250/50 mcg) self administered twice daily (BID) (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI or one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI. Salbutamol/albuterol was provided to use as rescue medication.
|
|---|---|
|
Age, Continuous
|
52.5 Years
STANDARD_DEVIATION 14.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
82 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 85Population: Intent-to-Treat (ITT) Population: all participants randomly assigned to treatment who received at least one dose of randomised study treatment in the Treatment Period. 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. The trough FEV1 is defined as morning prebronchodilator and predose (12 hours after the last evening dose Day 84). Trough FEV1 was measured electronically by spirometer in the morning, before using the bronchodilator and predose, at Week 12 (Day 85) of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on day 1 in each treatment period. Change from Baseline within each period was calculated as trough FEV1 at Day 85 minus the period specific Baseline value. The change from Baseline in trough FEV1 was analysed using Mixed Model for Repeated Measures analysis, having fixed effect Participant level Baseline, Adjusted period-specific Baseline, Treatment group, Period, Visit, Visit by treatment, Visit by Participant level Baseline, Visit by Adjusted period-specific Baseline, with participant as a random effect.
Outcome measures
| Measure |
FSC Capsule-Based Unit Dose DPI
n=78 Participants
Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
FSC Multi-Dose DPI
n=80 Participants
Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
|---|---|---|
|
Change From Baseline in Trough Morning Forced Expiratory Volume in 1 Second (FEV1) at Day 85
|
0.231 Liter
Standard Error 0.0339
|
0.203 Liter
Standard Error 0.0338
|
SECONDARY outcome
Timeframe: Day 1 of each Treatment PeriodPopulation: ITT population, Only those participants available at the specified time points were analyzed.
The AUC was analysed using a mixed effects analysis of covariance (ANCOVA) with participant-level baseline (day 1 trough FEV1), adjusted period-specific baseline (day 1 trough FEV1), treatment group and period as fixed effects and participant as a random effect.
Outcome measures
| Measure |
FSC Capsule-Based Unit Dose DPI
n=80 Participants
Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
FSC Multi-Dose DPI
n=80 Participants
Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
|---|---|---|
|
FEV1 Area Under the Curve From 0 to 12 Hours (AUC [0-12]) on Day 1 of Each Treatment Period
|
27.642 Liter*hours
Standard Error 0.3583
|
27.995 Liter*hours
Standard Error 0.3583
|
SECONDARY outcome
Timeframe: Day 85 of each Treatment PeriodPopulation: ITT population, Only those participants available at the specified time points were analyzed.
The AUC was analysed using a mixed effects analysis of covariance (ANCOVA) with participant-level baseline (day 1 trough FEV1), adjusted period-specific baseline (day 1 trough FEV1), treatment group and period as fixed effects and participant as a random effect.
Outcome measures
| Measure |
FSC Capsule-Based Unit Dose DPI
n=77 Participants
Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
FSC Multi-Dose DPI
n=79 Participants
Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
|---|---|---|
|
FEV1 AUC (0-12) at Day 85 of Each Treatment Period
|
28.317 Liter*hours
Standard Error 0.4307
|
28.039 Liter*hours
Standard Error 0.4285
|
SECONDARY outcome
Timeframe: Baseline, Day 28, and Day 56Population: ITT population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Participants at each time point may have been different therefore a total of 82 participants analyzed represents the overall ITT population.
Pulmonary function was measured by FEV1, a measure of lung function, and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry at predose (Baseline), on Days 28 and 56 of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on Day 1of each Treatment Period. Change from Baseline within each period was calculated as trough FEV1 at Day 28 and 56 minus the period specific Baseline value.The change from Baseline in trough FEV1 at Day 28 and Day 56 was analysed via the primary analysis model. Least Squares mean values for the change from Baseline in trough FEV1 at Day 28 and Day 56 were obtained from the primary analysis model (for each treatment and for the treatment difference), and displayed alongside corresponding 95% confidence intervals.
Outcome measures
| Measure |
FSC Capsule-Based Unit Dose DPI
n=82 Participants
Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
FSC Multi-Dose DPI
n=82 Participants
Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
|---|---|---|
|
Change From Baseline in Morning Trough FEV1 at Day 28 and Day 56
Day 28, n=81, 80
|
0.245 Liter
Standard Error 0.0402
|
0.238 Liter
Standard Error 0.0405
|
|
Change From Baseline in Morning Trough FEV1 at Day 28 and Day 56
Day 56, n=78, 80
|
0.224 Liter
Standard Error 0.0378
|
0.202 Liter
Standard Error 0.0377
|
SECONDARY outcome
Timeframe: Baseline and up to Day 85 of each Treatment PeriodPopulation: ITT population, Only those participants available at the specified time points were analyzed
The PEFR is a paricipant's(par) maximum speed of expiration, as measured with a peak flow meter(PFM). All par were issued a PFM and instructed to perform the activity in triplicate in the morning prior to taking the bronchodilator. The best among the 3 readings was selected. Efficacy measurement was recorded by the par in the paper Diary Card for morning PEFR. The total PEFR over the 12 week TP was divided by the number of days with non-missing PEFR data to obtain an average for each par. Change from BL in average morning PEFR is the difference over 12 weeks for each TP compared to BL. BL is the average of the last 4 available recorded values during the last 7 days of the Screening Period (for TP 1) and of the Washout Period (for TP 2). The change from BL in the PEFR averaged over the 12-week TP was analysed using a mixed effects ANCOVA model with participant level BL PEFR, adjusted period-specific BL PEFR, treatment group, and period as fixed effects, and par as a random effect.
Outcome measures
| Measure |
FSC Capsule-Based Unit Dose DPI
n=81 Participants
Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
FSC Multi-Dose DPI
n=80 Participants
Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
|---|---|---|
|
Change From Baseline (BL) in Morning Peak Expiratory Flow Rate (PEFR) Over 12 Weeks (From Paper Diary Card) for Each Treatment Period(TP)
|
23.02 Liters per minute
Standard Error 3.325
|
18.67 Liters per minute
Standard Error 3.338
|
SECONDARY outcome
Timeframe: Baseline and up to Day 85 of each Treatment PeriodPopulation: ITT population, Only those participants available at the specified time points were analyzed
Rescue medication usage for each 24-hour period is defined as the total numbers of puffs of Salbutamol/Albuterol within 24 hours (i.e. number taken during the day and number taken during the night). The total usage over the 12 week TP was divided by the number of days with nonmissing rescue medication data to get an average usage per participant. BL is the average of the last 4 available recorded values during the last 7 days of the Screening Period (for TP 1) and of the Washout Period (for TP 2). Change from BL in average usage of rescue medication was the difference over 12 weeks for each TP compared to BL. The change from BL in the percentage of rescue medication use averaged over the 12-week TP was analysed using mixed effects ANCOVA model, with par level BL rescue medication use, adjusted period-specific BL rescue medication use, treatment group and period as fixed effects and par as a random effect.
Outcome measures
| Measure |
FSC Capsule-Based Unit Dose DPI
n=81 Participants
Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
FSC Multi-Dose DPI
n=80 Participants
Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
|---|---|---|
|
Change From Baseline (BL) in Rescue Medication Use Over 12 Weeks (From Paper Diary Card) for Each Treatment Period (TP)
|
-0.41 Puffs per day
Standard Error 0.086
|
-0.36 Puffs per day
Standard Error 0.086
|
SECONDARY outcome
Timeframe: Baseline and up to Day 85 of each Treatment PeriodPopulation: ITT population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Participants at each time point may have been different therefore a total of 82 participants analyzed represents the overall ITT population.
AM Sy scores were recorded nightly on PDC using the scale:0=No Sy during day,1=Sy for one short period during day,2=Sy for two or more short periods during day,3=Sy for most of day-not affecting normal daily activities,4=Sy for most of day-did affect normal daily activities,5=Sy so severe-could not go to work or perform normal daily activities. Similarly, PM Sy scores were recorded every morning using the scale:0=No Sy during night,1=Sy causing me to wake once(or early),2=Sy causing me to wake twice or more(or early),3=Sy causing me to be awake most of night,4=Sy severe-did not sleep. BL= average of last 4 available of the last 7 days of Screening Period(TP 1) and of Washout Period(TP 2). Change from BL in average of daily scores=difference over 12 wks for each TP compared to BL. AM and PM Sy Scores were separately averaged over each of the two 12-wk TP. Total value of each endpoint over 12-wk TP was divided by number of days with non-missing data to obtain an average for each subject
Outcome measures
| Measure |
FSC Capsule-Based Unit Dose DPI
n=82 Participants
Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
FSC Multi-Dose DPI
n=82 Participants
Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
|---|---|---|
|
Change From Baseline in Day-time(AM) and Night-time (PM) Asthma Symptoms(Sy) From Paper Diary Card (PDC) Over 12 Weeks(wk) for Each Treatment Period(TP)
Day time (AM) score, n=81, 80
|
-0.38 Scores on the scale
Standard Deviation 0.685
|
-0.25 Scores on the scale
Standard Deviation 0.706
|
|
Change From Baseline in Day-time(AM) and Night-time (PM) Asthma Symptoms(Sy) From Paper Diary Card (PDC) Over 12 Weeks(wk) for Each Treatment Period(TP)
Night time (PM) score, n= 81, 80
|
-0.16 Scores on the scale
Standard Deviation 0.421
|
-0.14 Scores on the scale
Standard Deviation 0.389
|
SECONDARY outcome
Timeframe: Baseline and up to Day 85 of each Treatment PeriodPopulation: ITT population, Only those participants available at the specified time points were analyzed
A Symptom-Free day was defined as a 24-hour period with no symptoms recorded. Percentage of Symptom-Free Days was calculated dividing number of Symptom-Free days by the length of the Treatment Period. The baseline value of change from baseline in % of symptom free days is defined as an average of the last 7 available recorded values the Screening Period (for treatment period 1) and of the Washout Period (for treatment period 2). Change from Baseline was the difference in percentage of Symptom-Free days at week 12 compared to Baseline. The change from Baseline in the percentage of Symptom-Free days averaged over the 12-week Treatment Period was analyzed, using mixed effects ANCOVA model, with participant level Baseline percentage of Symptom-Free days, adjusted period-specific Baseline percentage of Symptom-Free days, treatment group and period as fixed effects and participant as a random effect.
Outcome measures
| Measure |
FSC Capsule-Based Unit Dose DPI
n=81 Participants
Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
FSC Multi-Dose DPI
n=80 Participants
Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
|---|---|---|
|
Change From Baseline in the Percentage of Symptom-Free Days From Paper Diary Card Over 12 Weeks
|
11.36 Percentage of symptom-free days
Standard Error 2.852
|
13.61 Percentage of symptom-free days
Standard Error 2.864
|
SECONDARY outcome
Timeframe: Baseline and up to Day 85 of each Treatment PeriodPopulation: ITT population, Only those participants available at the specified time points were analyzed
The ACT is a 5-item questionnaire with a score of 1 to 5 for each item (1=poor control and 5=good control). The scores from each question were added to give an overall score. Baseline was defined as the value obtained predose (0 minutes) on day 1 of each Treatment Period. Change from Baseline was the difference in ACT score at the timepoint compared to Baseline score. The change from Baseline in overall ACT score was analysed, using mixed effects ANCOVA model, with participant level Baseline overall ACT score, adjusted period-specific Baseline overall ACT score, treatment group and period as fixed effects and participant as a random effect.
Outcome measures
| Measure |
FSC Capsule-Based Unit Dose DPI
n=78 Participants
Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
FSC Multi-Dose DPI
n=80 Participants
Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
|---|---|---|
|
Change From Baseline in Asthma Control Test (ACT) Over 12 Weeks for Each Treatment Period
|
3.0 Scores on the scale
Standard Error 0.35
|
3.2 Scores on the scale
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Baseline and up to Day 85 of each Treatment PeriodPopulation: ITT population, Only those participants available at the specified time points were analyzed
A rescue-free day is defined as a 24-hour period with no rescue medication usage recorded (i.e. both the day-time and night-time numbers of puffs of Salbutamol/Albuterol are zero). Percentage of Rescue-Free Days was calculated over each 12-week Treatment Period, dividing the number of rescue-free days by the length of the TP. The BL value of change from BL in % rescue free days is defined as an average of the last 7 available recorded values the Screening Period (for treatment period 1) and of the Washout Period (for treatment period 2). Change from BL was the difference over 12 weeks for each treatment period compared to BL. The change from BL in the % of rescue medication-free days averaged over the 12-week TP was analyzed, using mixed effects ANCOVA model, with par level BL % of rescue-free days, adjusted period-specific BL % of rescue-free days treatment group and period as fixed effects and par as a random effect.
Outcome measures
| Measure |
FSC Capsule-Based Unit Dose DPI
n=81 Participants
Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
FSC Multi-Dose DPI
n=80 Participants
Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
|---|---|---|
|
Change From Baseline in the Percentage (%) of Rescue-free Days Over 12 Weeks (From Paper Diary Card) for Each Treatment Period(TP)
|
6.04 Percentage of rescue-free days
Standard Error 2.391
|
6.81 Percentage of rescue-free days
Standard Error 2.400
|
Adverse Events
FSC Capsule-Based Unit Dose DPI
FSC Multi-Dose DPI
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FSC Capsule-Based Unit Dose DPI
n=82 participants at risk
Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
FSC Multi-Dose DPI
n=82 participants at risk
Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
|
|---|---|---|
|
Nervous system disorders
Headache
|
11.0%
9/82 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug untill the follow-up contact (up to Week 28).
SAEs and non-serious AEs were collected in members of the safety population, comprised of all participants randomised to treatment, who had received at least one dose of study medication.
|
12.2%
10/82 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug untill the follow-up contact (up to Week 28).
SAEs and non-serious AEs were collected in members of the safety population, comprised of all participants randomised to treatment, who had received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
6.1%
5/82 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug untill the follow-up contact (up to Week 28).
SAEs and non-serious AEs were collected in members of the safety population, comprised of all participants randomised to treatment, who had received at least one dose of study medication.
|
4.9%
4/82 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug untill the follow-up contact (up to Week 28).
SAEs and non-serious AEs were collected in members of the safety population, comprised of all participants randomised to treatment, who had received at least one dose of study medication.
|
|
Investigations
Blood pressure increased
|
0.00%
0/82 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug untill the follow-up contact (up to Week 28).
SAEs and non-serious AEs were collected in members of the safety population, comprised of all participants randomised to treatment, who had received at least one dose of study medication.
|
3.7%
3/82 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug untill the follow-up contact (up to Week 28).
SAEs and non-serious AEs were collected in members of the safety population, comprised of all participants randomised to treatment, who had 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