At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Multi-Centre, Double-Blind, Double-Dummy, Two Way Cross-Over, Twelve Weeks Non-inferiority Study to Evaluate the Efficacy, Safety, and Tolerability of Combination Dry Powder of Fluticasone Propionate and Salmeterol 250/50 mcg Twice Daily Delivered Through a Capsule-Based Inhaler and a Multi-Dose Inhaler in Adults and Adolescents With Asthma
In Brief
A Phase 3 clinical trial evaluating FSC and Placebo for Asthma. Completed, enrolled 124 participants across 13 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
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
Subject will be administered placebo via dry powder inhalation device or multi-dose dry powder inhalation device BID for each treatment period