Conditions: Asthma
Keywords: Multi-Dose Inhaler safety Asthma efficacy pharmacodynamics fluticasone propionate/salmeterol (FSC) 250/50 mcg tolerability Capsule-Based Inhaler
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 124
Healthy volunteers: no

Brief summary:
This is a multi-centre, randomised, double-blind, double-dummy, two way cross-over, 12 week non inferiority study to evaluate the efficacy, safety, and tolerability of FSC 250/50 mcg capsule-based inhaler and FSC 250/50 mcg multi-dose inhaler each administered BID in adults and adolescents with asthma. The primary objective of this study is to demonstrate that FSC 250/50 mcg administered BID by capsule-based inhaler is non-inferior compared to FSC 250/50 mcg administered BID by multi-dose inhaler . The study consists of six phases: Pre-screening, Screening/Run-in (3 weeks), Treatment Period 1 (12 weeks), Washout (minimum 3 weeks), Treatment Period 2 (12 weeks) and Follow-up (1 week). The total duration of the study for each subject will be at least 31 weeks.

Detailed description:

Arms:
arm 1: Subjects in this Arm will receive Regimen A followed by Regimen B. Regimen A: Placebo administered BID by Multi-Dose Inhaler followed by FSC (250/50 mcg) administered BID by Capsule-Based Inhaler. Regimen B: FSC (250/50 mcg) administered BID by Multi-Dose Inhaler followed by Placebo administered BID by Capsule-Based Inhaler arm 2: Subjects in this Arm will receive Regimen B followed by Regimen A. Regimen B: FSC (250/50 mcg) administered BID by Multi-Dose Inhaler followed by Placebo administered BID by Capsule-Based Inhaler. Regimen A: Placebo administered BID by Multi-Dose Inhaler followed by FSC (250/50 mcg) 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 period intervention 2: Subject will be administered placebo via dry powder inhalation device or multi-dose dry powder inhalation device BID for each treatment period

Protocol document: