Asthma Clinical Trial
Official title:
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
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.
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