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: 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
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top