At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Repeat-dose, Placebo-controlled, Double-blind Study to Evaluate and Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder, When Administered Either in the Morning or in the Evening, in Male and Female Asthmatic Subjects
In Brief
A Phase 2 clinical trial evaluating FF(100mcg)/Vilanterol(25mcg) AM, FF(100mcg)/Vilanterol(25mcg) PM, and 2 other interventions for Asthma. Completed, enrolled 26 participants across 1 site.
Detailed Summary
This study will be a repeat-dose, double-blind, randomized, placebo controlled, three-way crossover study in patients with persistent bronchial asthma to compare the effect of morning (AM) and evening (PM) dosing with fluticasone furoate (FF)/Vilanterol (VI) inhalation powder on lung function. Following screening there will be a run-in period of 14 days. There will be 3 treatment periods; drug at AM, drug at PM and placebo, which will last for 14 days each with a 14-21 day washout period between starting the next. Key assessments include; forced expiratory volume in one second (FEV1), peak expiratory flow (PEF), vital signs, electrocardiograms (ECGs), adverse event (AE) monitoring and laboratory safety tests.
Study Details
Timeline
Interventions
Inhalation powder
Inhalation powder
Inhalation powder
Inhalation powder