The Efficacy of Fluticasone Furoate/Vilanterol Versus (vs) Fluticasone Furoate on Asthma
Status:
Withdrawn
Trial end date:
2019-05-29
Target enrollment:
Participant gender:
Summary
The objective of this study is to evaluate fluticasone furoate/vilanterol compared with
fluticasone furoate alone in subjects with asthma that is uncontrolled on low to mid dose
inhaled corticosteroid (ICS) or low dose ICS/ long acting beta agonist (LABA) combination.
This is a phase IV, randomized, double-blind, parallel group, multicenter study evaluating
fluticasone furoate/vilanterol 100/25 micrograms (mcg) and fluticasone furoate 100 mcg once
daily, delivered as an inhalation powder using the ELLIPTA® device in subjects with
uncontrolled asthma despite daily ICS or ICS/LABA therapy. The study will measure treatment
response and asthma control using the Asthma Control Questionnaire-7 (ACQ-7) focusing on
symptomatic control. In this study, proportion of subjects with an improvement in ACQ-7 score
of >=0.5 at Week 12 compared to Baseline for the fluticasone furoate/vilanterol 100 mcg/25
mcg and fluticasone furoate100 mcg groups will be assessed. The total study duration for each
subject will be 17 weeks including 4-week run in period, 12-week treatment period and 1-week
follow up period. Approximately 1012 subjects will be randomized into the study. ELLIPTA is a
registered trademark of GlaxoSmithKline group of companies.