Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: efficacy tolerability capsule-based inhaler quality of life safety multi-dose inhaler fluticasone propionate/salmeterol (FSC) 250/50 mcg Chronic obstructive pulmonary disease
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 665
Healthy volunteers: no

Brief summary:
This is a multi-centre, randomised, double-blind, double-dummy, two way cross-over, 12 weeks noninferiority study to evaluate the efficacy, safety, and tolerability of FSC 250/50 mcg capsule-based inhaler and a multi-dose inhaler administered BID in adults with COPD. The primary objective of this study is to establish the non-inferiority of the efficacy of the FSC 250/50 mcg capsule-based inhaler compared to the FSC 250/50 mcg multi-dose inhaler administered BID. The study consists of 6 phases: Pre-screening, Screening/Run-in (3 weeks), Treatment Period 1 (12 weeks), Washout (minimum 4 weeks), Treatment Period 2 (12 weeks) and Follow-up (1 week). The total duration of the study for each subject will be at least 32 weeks.

Detailed description:

Arms:
arm 1: Placebo administered BID by multi-dose inhaler followed by FSC (250/50 mcg) administered BID by capsule-based inhaler. arm 2: FSC (250/50 mcg) administered BID by multi-dose inhaler followed by placebo administered BID by capsule-based inhaler.

Interventions: intervention 1: FSC intervention 2: Placebo
Intervention descriptions: intervention 1: Subject will be administered FSC 250 mcg/50 mcg via dry powder inhalation device -or multi-dose dry powder inhalation device BID for each treatment periods intervention 2: Subject will be administered placebo via dry powder inhalation device or multi-dose dry powder inhalation device BID for each treatment periods

Protocol document: