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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Dec 2017

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
  • Most Recent Events

    • 23 Nov 2017 According to a GlaxoSmithKline media release, based on the data from this study, the company has submitted a supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) for the use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), for an expanded indication for the maintenance treatment of airflow obstruction and reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
    • 07 Nov 2017 According to a Theravance Biopharma media release, regulatory filings for data from this trial are expected in 2018.
    • 20 Sep 2017 Primary endpoint has been met. (Annual rate of on-treatment moderate and severe exacerbations comparing FF/UMEC/VI with FF/VI), according to a GlaxoSmithKline media release.
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