A Randomized, Double-blind, Double-dummy, Parallel Group, Multicenter Study of Once Daily Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, Twice Daily Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Twice Daily Fluticasone Propionate 250 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents Already Adequately Controlled on Twice-daily Inhaled Corticosteroid and Long-acting beta2 Agonist
Phase of Trial: Phase III
Latest Information Update: 21 Jul 2017
At a glance
- Drugs Vilanterol/fluticasone furoate (Primary) ; Fluticasone propionate; Salmeterol/fluticasone propionate
- Indications Asthma
- Focus Registrational; Therapeutic Use
- Sponsors GlaxoSmithKline
- 21 Jul 2017 According to a GlaxoSmithKline media release, the company has announced a submission to the EMA for the extended use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI) in patients already adequately controlled on an ICS/LABA combination. The submission includes data from this trial.
- 23 Feb 2017 Primary endpoint has been met. (Change from baseline in clinic visit evening (PM) forced expiratory volume in one second (FEV1) (pre-bronchodilator and predose) at the end of the 24-week treatment period), as per the results published at a GlaxoSmithKline media release.
- 23 Feb 2017 Results published in a GlaxoSmithKline media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History