Clinical trial NCT02301975
Conditions: Asthma
Keywords: Adult asthma Fluticasone Propionate Adolescents Salmeterol Vilanterol ELLIPTA ACCUHALER/DISKUS Non-inferior Fluticasone Furoate
Sponsor: GlaxoSmithKline
Start date: 2015-03-01; Completion date: 2016-11-25
Enrollment: 1526 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Detailed description:

Arms: arm 1: 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. arm 2: 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. arm 3: FP 250 mcg by inhalation BD (AM and PM) via ACCUHALER/DISKUS plus placebo by inhalation OD (PM) via ELLIPTA for 24 weeks.
Interventions: intervention 1: Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler intervention 2: Placebo inhalation powders via ELLIPTA inhaler intervention 3: Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler intervention 4: Placebo inhalation powder via ACCUHALER/DISKUS inhaler intervention 5: Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler
Intervention descriptions: intervention 1: FF/Vilanterol 100/25 mcg inhalation powders administered once daily via ELLIPTA inhaler. 30 doses per device and 100/25 mcg per actuation. intervention 2: Placebo inhalation powders administered once daily via ELLIPTA inhaler. 30 doses per device. intervention 3: FP/Salmeterol 250/50 mcg inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device and 250/50 mcg per actuation. intervention 4: Placebo inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device. intervention 5: FP 250 mcg inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device and 250 mcg per actuation.

Protocol documents: