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.

Trial Profile

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.

Completed
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
  • Most Recent Events

    • 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.
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