NCT03363191

The Efficacy of Fluticasone Furoate/Vilanterol Versus (vs) Fluticasone Furoate on Asthma

A Randomised, Double-blind, Parallel Group, Multicentre Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol 100/25mcg Versus Fluticasone Furoate 100mcg on Asthma Control in Patients With Uncontrolled Asthma

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Fluticasone Furoate/Vilanterol	Fluticasone furoate/vilanterol will be supplied as inhalation powder in ELLIPTA DPI. It will contain 2 strips with 30 blisters per strip. First strip will contain fluticasone furoate 100 mcg dry white powder blended with lactose. Second strip will contain vilanterol 25 mcg dry white powder blended with lactose and magnesium stearate.
DRUG	Fluticasone Furoate	Fluticasone furoate will be supplied as inhalation powder in ELLIPTA DPI. It will contain a single strip with 30 blisters, containing fluticasone furoate 100 mcg dry white powder blended with lactose.
DRUG	Salbutamol/Albuterol	Salbutamol/albuterol will be provided to subjects to use as rescue medication on an as-needed basis.

Timeline

• Start date: 2018-03-07
• Primary completion: 2019-05-29
• Completion: 2019-05-29
• First posted: 2017-12-06
• Last updated: 2018-01-29

Regulatory

• FDA-regulated drug study