Trial Outcomes & Findings for An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Persistent Asthma (NCT NCT02301975)
NCT ID: NCT02301975
Last Updated: 2018-08-06
Results Overview
FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the mixed model repeated measures (MMRM) model and least square mean and standard error were calculated. The analysis was performed on ITT Population which comprised of all participants randomized to treatment and who received at least one dose of study medication.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1526 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2018-08-06
Participant Flow
Eligible participants at screening and run-in visits entered a 24 Week treatment period and were randomized to receive either Fluticasone furoate/Vilanterol (FF/VI) 100/25 micrograms (mcg) or Fluticasone propionate/salmeterol (FP/S) 250/50mcg or only FP 250mcg followed by a follow-up phase. The total duration for study participation was 30 weeks.
A total of 3162 adult and adolescent participants with asthma were screened, out of which 516 were screen-failures, 1124 were run-in failures, 1522 participants were randomized, and 1504 subjects received at least one dose of study medication to be included in the Intent-to-Treat (ITT) Population.
Participant milestones
| Measure |
FF/VI 100/25 mcg Once Daily
Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP/S 250/50 mcg Twice Daily
Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP 250 mcg Twice Daily
Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
|---|---|---|---|
|
Overall Study
STARTED
|
504
|
501
|
499
|
|
Overall Study
COMPLETED
|
473
|
476
|
477
|
|
Overall Study
NOT COMPLETED
|
31
|
25
|
22
|
Reasons for withdrawal
| Measure |
FF/VI 100/25 mcg Once Daily
Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP/S 250/50 mcg Twice Daily
Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP 250 mcg Twice Daily
Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
3
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
1
|
|
Overall Study
Protocol Violation
|
3
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
|
Overall Study
Physician Decision
|
4
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
15
|
12
|
11
|
Baseline Characteristics
An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Persistent Asthma
Baseline characteristics by cohort
| Measure |
FF/VI 100/25 mcg Once Daily
n=504 Participants
Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP/S 250/50 mcg Twice Daily
n=501 Participants
Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP 250 mcg Twice Daily
n=499 Participants
Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
Total
n=1504 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.4 Participants
STANDARD_DEVIATION 16.30 • n=5 Participants
|
43.0 Participants
STANDARD_DEVIATION 15.20 • n=7 Participants
|
43.0 Participants
STANDARD_DEVIATION 16.58 • n=5 Participants
|
43.5 Participants
STANDARD_DEVIATION 16.04 • n=4 Participants
|
|
Sex: Female, Male
Female
|
314 Participants
n=5 Participants
|
336 Participants
n=7 Participants
|
314 Participants
n=5 Participants
|
964 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
190 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
540 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian- Japanese Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian- South East Asian Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African American Heritage
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White- Arabic/ North African Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White- White/Caucasian/European Heritage
|
415 Participants
n=5 Participants
|
407 Participants
n=7 Participants
|
410 Participants
n=5 Participants
|
1232 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White- Mixed White Race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American/ African and White Heritage
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native and White Heritage
|
66 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
192 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian and White Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: ITT population
FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the mixed model repeated measures (MMRM) model and least square mean and standard error were calculated. The analysis was performed on ITT Population which comprised of all participants randomized to treatment and who received at least one dose of study medication.
Outcome measures
| Measure |
FF/VI 100/25 mcg Once Daily
n=487 Participants
Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP/S 250/50 mcg Twice Daily
n=487 Participants
Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP 250 mcg Twice Daily
n=479 Participants
Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
|---|---|---|---|
|
Change From Baseline in Evening (Post Meridiem [PM]) Forced Expiratory Volume in One Second (FEV1) Using Intent-to-Treat (ITT) Population
|
0.019 Liter (L)
Standard Error 0.0107
|
0.000 Liter (L)
Standard Error 0.0108
|
-0.104 Liter (L)
Standard Error 0.0109
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: PP Population
FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the MMRM models and least square mean and standard error were calculated. The analysis was performed on PP Population which comprised of all participants in the ITT Population who did not had any full protocol deviations.
Outcome measures
| Measure |
FF/VI 100/25 mcg Once Daily
n=425 Participants
Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP/S 250/50 mcg Twice Daily
n=426 Participants
Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP 250 mcg Twice Daily
n=419 Participants
Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
|---|---|---|---|
|
Change From Baseline in PM FEV1 Using Per Protocol (PP) Population
|
0.020 L
Standard Error 0.0120
|
0.014 L
Standard Error 0.0120
|
-0.099 L
Standard Error 0.0121
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-24Population: ITT Population
The number of inhalations of rescue medication used during the day and night were recorded by participants using an electronic diary (e-diary). A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.
Outcome measures
| Measure |
FF/VI 100/25 mcg Once Daily
n=500 Participants
Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP/S 250/50 mcg Twice Daily
n=498 Participants
Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP 250 mcg Twice Daily
n=496 Participants
Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
|---|---|---|---|
|
Change From Baseline in the Percentage of Rescue-free 24-hour Periods
|
-3.0 Percentage of rescue-free 24-hr periods
Standard Error 0.62
|
-4.2 Percentage of rescue-free 24-hr periods
Standard Error 0.62
|
-5.7 Percentage of rescue-free 24-hr periods
Standard Error 0.62
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-24Population: ITT Population
Change from Baseline in the percentage of symptom-free 24 hour period was evaluated. 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 value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week treatment period minus the Baseline value.Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.
Outcome measures
| Measure |
FF/VI 100/25 mcg Once Daily
n=500 Participants
Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP/S 250/50 mcg Twice Daily
n=498 Participants
Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP 250 mcg Twice Daily
n=496 Participants
Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
|---|---|---|---|
|
Change From Baseline in the Percentage of Symptom-free 24-hour Periods
|
-3.5 Percentage of symptom-free 24 hour perio
Standard Error 0.67
|
-4.7 Percentage of symptom-free 24 hour perio
Standard Error 0.67
|
-6.2 Percentage of symptom-free 24 hour perio
Standard Error 0.67
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-24Population: ITT Population
PEF was measured using an electric flow meter each morning. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.
Outcome measures
| Measure |
FF/VI 100/25 mcg Once Daily
n=501 Participants
Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP/S 250/50 mcg Twice Daily
n=499 Participants
Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP 250 mcg Twice Daily
n=497 Participants
Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
|---|---|---|---|
|
Change From Baseline in Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF)
|
8.9 Liter per minute (L/min)
Standard Error 1.48
|
3.7 Liter per minute (L/min)
Standard Error 1.49
|
-12.6 Liter per minute (L/min)
Standard Error 1.49
|
SECONDARY outcome
Timeframe: Week 24Population: ITT Population
The ACT was a five-item questionnaire developed as a measure of participant's asthma control. The percentage of participants controlled, defined as having ACT score greater than or equal to 20 at the end of Week 24 were analyzed using logistic regression model with covariates of Baseline ACT score, region, sex, age and treatment group.
Outcome measures
| Measure |
FF/VI 100/25 mcg Once Daily
n=471 Participants
Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP/S 250/50 mcg Twice Daily
n=467 Participants
Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP 250 mcg Twice Daily
n=461 Participants
Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
|---|---|---|---|
|
Percentage of Participants With Asthma Control Test (ACT) Score Greater Than or Equal to 20
|
92 Percentage of participants
|
93 Percentage of participants
|
91 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-24Population: ITT Population
PEF was measured using an electric flow meter each evening. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.
Outcome measures
| Measure |
FF/VI 100/25 mcg Once Daily
n=501 Participants
Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP/S 250/50 mcg Twice Daily
n=498 Participants
Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP 250 mcg Twice Daily
n=496 Participants
Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
|---|---|---|---|
|
Change From Baseline in PM PEF
|
5.5 L/min
Standard Error 1.55
|
0.5 L/min
Standard Error 1.55
|
-13.7 L/min
Standard Error 1.55
|
Adverse Events
FF/VI 100/25 mcg Once Daily
Serious events: 6 serious events
Other events: 126 other events
Deaths: 0 deaths
FP/S 250/50 mcg Twice Daily
Serious events: 4 serious events
Other events: 123 other events
Deaths: 0 deaths
FP 250 mcg Twice Daily
Serious events: 5 serious events
Other events: 124 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FF/VI 100/25 mcg Once Daily
n=504 participants at risk
Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP/S 250/50 mcg Twice Daily
n=501 participants at risk
Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP 250 mcg Twice Daily
n=499 participants at risk
Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
|---|---|---|---|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.20%
1/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.20%
1/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.20%
1/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Infections and infestations
Pneumonia
|
0.20%
1/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.20%
1/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.20%
1/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.20%
1/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.00%
0/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.20%
1/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.20%
1/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.20%
1/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.20%
1/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.20%
1/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.20%
1/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Renal and urinary disorders
Renal colic
|
0.20%
1/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord leukoplakia
|
0.00%
0/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.20%
1/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Vascular disorders
Hypertension
|
0.00%
0/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.00%
0/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
0.20%
1/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
Other adverse events
| Measure |
FF/VI 100/25 mcg Once Daily
n=504 participants at risk
Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP/S 250/50 mcg Twice Daily
n=501 participants at risk
Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
FP 250 mcg Twice Daily
n=499 participants at risk
Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
|
|---|---|---|---|
|
Infections and infestations
Bronchitis
|
4.0%
20/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
2.0%
10/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
2.6%
13/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Infections and infestations
Influenza
|
1.8%
9/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
2.4%
12/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
3.8%
19/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Infections and infestations
Nasopharyngitis
|
12.1%
61/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
13.4%
67/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
11.4%
57/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Infections and infestations
Pharyngitis
|
3.0%
15/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
2.6%
13/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
3.6%
18/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
|
Nervous system disorders
Headache
|
8.1%
41/504 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
7.4%
37/501 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
8.0%
40/499 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
|
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