A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease
Phase of Trial: Phase III
Latest Information Update: 24 Apr 2018
At a glance
- Drugs Fluticasone furoate/umeclidinium/vilanterol (Primary) ; Umeclidinium/vilanterol; Vilanterol/fluticasone furoate
- Indications Chronic obstructive pulmonary disease
- Focus Registrational; Therapeutic Use
- Acronyms IMPACT
- Sponsors GlaxoSmithKline
- 24 Apr 2018 According to a GlaxoSmithKline media release, under the new expanded indication approval Trelegy Ellipta is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
- 24 Apr 2018 Based on the data from this trial, the US FDA has approved an expanded indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), to treat a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who have experienced an acute worsening of respiratory symptoms. The new indication is for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.
- 19 Apr 2018 Results presented in a Theravance Biopharma in the Media Release.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History