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A 52-week, Double Blind, Double dummy, Randomized, Multinational, Multicentre, 2-arm Parallel Group, active Controlled Clinical Trial of fixed combination of beclometasone dipropionate plus formoterol fumarate plus Glycopyrronium bromide administered via pMDI (CHF 5993) versus indacaterol/glycopyrronium (Ultibro) via DPI in patients with Chronic Obstructive Pulmonary Disease

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Trial Profile

A 52-week, Double Blind, Double dummy, Randomized, Multinational, Multicentre, 2-arm Parallel Group, active Controlled Clinical Trial of fixed combination of beclometasone dipropionate plus formoterol fumarate plus Glycopyrronium bromide administered via pMDI (CHF 5993) versus indacaterol/glycopyrronium (Ultibro) via DPI in patients with Chronic Obstructive Pulmonary Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Beclometasone/formoterol/glycopyrrolate (Primary) ; Glycopyrrolate/indacaterol
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms TRIBUTE
  • Sponsors Chiesi Farmaceutici

    • Most Recent Events

    • 19 Sep 2018 Results assessing the quality of life of fixed triple combination of extrafine beclometasone dipropionate, formoterol fumarate and glycopyrronium in chronic obstructive pulmonary disease patients, presented at the 28th Annual Congress of the European Respiratory Society.
    • 19 Sep 2018 Results of post-hoc analysis assessing the efficacy of extrafine BDP/FF/G was superior to IND/GLY for reducing exacerbations in Chronic obstructive pulmonary disease patients, presented at the 28th Annual Congress of the European Respiratory Society.
    • 19 Sep 2018 Results of a stratified safety pooled analysis of fatal adverse events (AEs) comparing extrafine ICS-containing combinations vs ICS-free treatments from TRILOGY, TRINITY and TRIBUTE studies presented at the 28th Annual Congress of the European Respiratory Society

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