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Clinical Trials/NCT02301975
NCT02301975
Completed
Phase 3

A Randomized, Double-blind, Double-dummy, Parallel Group, Multicenter Study of Once Daily Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, Twice Daily Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Twice Daily Fluticasone Propionate 250 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents Already Adequately Controlled on Twice-daily Inhaled Corticosteroid and Long-acting beta2 Agonist

GlaxoSmithKline1 site in 1 country1,526 target enrollmentMarch 1, 2015

Overview

Phase
Phase 3
Intervention
Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler
Conditions
Asthma
Sponsor
GlaxoSmithKline
Enrollment
1526
Locations
1
Primary Endpoint
Change From Baseline in Evening (Post Meridiem [PM]) Forced Expiratory Volume in One Second (FEV1) Using Intent-to-Treat (ITT) Population
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) (equivalent to fluticasone propionate [FP]/salmeterol 250/50 microgram [mcg]twice daily [BD]), either via a fixed dose combination product or through separate inhalers. The study consists of a LABA washout period of 5 days and a run-in period of 4 weeks, followed by a treatment period of 24 weeks, and a follow up contact period of one week. The total duration of the study is 30 weeks. Approximately 1461 subjects will be randomized to one of the following three treatments (487 per treatment): fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg once daily (OD) in the evening (PM) via ELLIPTA™ inhaler plus placebo BD via ACCUHALER™/DISKUS™; FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler; FP 250 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler. In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms. This study will determine if FF/VI 100/25 mcg OD via ELLIPTA inhaler is non-inferior to FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler in adult and adolescent asthmatic subjects already adequately controlled on a twice-daily ICS/LABA.

SERETIDE, ELLIPTA, ACCUHALER, RELVAR, and DISKUS are trademarks of the GlaxoSmithKline Group of Companies.

Registry
clinicaltrials.gov
Start Date
March 1, 2015
End Date
November 25, 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Fluticasone Furoate/Vilanterol 100/25 mcg

FF/VI 100/25 mcg by inhalation OD (PM) via ELLIPTA plus placebo by inhalation BD (AM and PM) via ACCUHALER/DISKUS for 24 weeks.

Intervention: Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler

Fluticasone Furoate/Vilanterol 100/25 mcg

FF/VI 100/25 mcg by inhalation OD (PM) via ELLIPTA plus placebo by inhalation BD (AM and PM) via ACCUHALER/DISKUS for 24 weeks.

Intervention: Placebo inhalation powder via ACCUHALER/DISKUS inhaler

Fluticasone Propionate/Salmeterol 250/50 mcg

FP/Salmeterol 250/50 mcg by inhalation BD (AM and PM) via ACCUHALER/DISKUS plus placebo by inhalation OD (PM) via ELLIPTA for 24 weeks.

Intervention: Placebo inhalation powders via ELLIPTA inhaler

Fluticasone Propionate/Salmeterol 250/50 mcg

FP/Salmeterol 250/50 mcg by inhalation BD (AM and PM) via ACCUHALER/DISKUS plus placebo by inhalation OD (PM) via ELLIPTA for 24 weeks.

Intervention: Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler

Fluticasone Propionate 250 mcg

FP 250 mcg by inhalation BD (AM and PM) via ACCUHALER/DISKUS plus placebo by inhalation OD (PM) via ELLIPTA for 24 weeks.

Intervention: Placebo inhalation powders via ELLIPTA inhaler

Fluticasone Propionate 250 mcg

FP 250 mcg by inhalation BD (AM and PM) via ACCUHALER/DISKUS plus placebo by inhalation OD (PM) via ELLIPTA for 24 weeks.

Intervention: Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler

Outcomes

Primary Outcomes

Change From Baseline in Evening (Post Meridiem [PM]) Forced Expiratory Volume in One Second (FEV1) Using Intent-to-Treat (ITT) Population

Time Frame: Baseline and Week 24

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.

Change From Baseline in PM FEV1 Using Per Protocol (PP) Population

Time Frame: Baseline and Week 24

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.

Secondary Outcomes

  • Change From Baseline in PM PEF(Baseline and Weeks 1-24)
  • Change From Baseline in the Percentage of Rescue-free 24-hour Periods(Baseline and Weeks 1-24)
  • Change From Baseline in the Percentage of Symptom-free 24-hour Periods(Baseline and Weeks 1-24)
  • Change From Baseline in Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF)(Baseline and Weeks 1-24)
  • Percentage of Participants With Asthma Control Test (ACT) Score Greater Than or Equal to 20(Week 24)

Study Sites (1)

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