A Phase III, 24 week, randomized, double blind, double dummy, parallel group study (with an extension to 52 weeks in a subset of subjects) comparing the efficacy, safety and tolerability of the fixed dose triple combination FF/UMEC/VI administered once-daily in the morning via a dry powder inhaler with budesonide/formoterol 400mcg/12mcg administered twice-daily via a reservoir inhaler in subjects with chronic obstructive pulmonary disease.
Phase of Trial: Phase III
Latest Information Update: 16 Nov 2017
At a glance
- Drugs Fluticasone furoate/umeclidinium/vilanterol (Primary) ; Budesonide/formoterol
- Indications Chronic obstructive pulmonary disease
- Focus Registrational; Therapeutic Use
- Acronyms FULFIL
- Sponsors GlaxoSmithKline
- 16 Nov 2017 According to a Theravance Biopharma media release, the European Commission has granted marketing authorization for Trelegy Ellipta, the triple combination therapy of fluticasone furoate, umeclidinium, and vilanterol in a single ELLIPTA inhaler, as a maintenance treatment for adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.
- 15 Sep 2017 According to a GlaxoSmithKline media release, GlaxoSmithKline and Innoviva announced that the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI) as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD).
- 24 May 2017 Results assessing patient reported symptom severity, rescue medication use, and inhaler preference, presented at the 113th International Conference of the American Thoracic Society.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History