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A Phase IV, 12 Week, Randomised, Double-blind, Double-dummy Study to Compare Single Inhaler Triple Therapy, Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI), With Tiotropium Monotherapy Based on Lung Function and Symptoms in Participants With Chronic Obstructive Pulmonary Disease

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Trial Profile

A Phase IV, 12 Week, Randomised, Double-blind, Double-dummy Study to Compare Single Inhaler Triple Therapy, Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI), With Tiotropium Monotherapy Based on Lung Function and Symptoms in Participants With Chronic Obstructive Pulmonary Disease

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 04 Sep 2023

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At a glance

  • Drugs Fluticasone furoate/umeclidinium/vilanterol (Primary) ; Salbutamol; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Therapeutic Use
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Research & Development; GSK

    • Most Recent Events

    • 03 Dec 2021 Results assessing the cost-effectiveness of once-daily fluticasone furoate-umeclidinium-vilanterol 100-62.5-25 microgm compared with once-daily tiotropium 18 microgm in patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations from UK National Healthcare System perspective, presented at the 24th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
    • 21 Oct 2020 Results of post-hoc analysis presented at the CHEST Annual Meeting 2020 by Annual Meeting of the American College of Chest Physicians.
    • 20 May 2020 Primary endpoint, Change from Baseline in trough forced expiratory volume in 1 second (FEV1) at Day 85, has been met as per results presented at the 116th International Conference of the American Thoracic Society
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