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A 52-week, double-blind, randomized, multinational, multicentre, 2-arm parallel-group, active-controlled clinical trial of fixed combination of beclometasone dipropionate plus formoterol fumarate plus glycopyrrolate bromide administered via pMDI (CHF 5993) versus fixed combination of beclometasone dipropionate plus formoterol fumarate administered via pMDI in Patients with Chronic Obstructive Pulmonary Disease

Trial Profile

A 52-week, double-blind, randomized, multinational, multicentre, 2-arm parallel-group, active-controlled clinical trial of fixed combination of beclometasone dipropionate plus formoterol fumarate plus glycopyrrolate bromide administered via pMDI (CHF 5993) versus fixed combination of beclometasone dipropionate plus formoterol fumarate administered via pMDI in Patients with Chronic Obstructive Pulmonary Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Sep 2018

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At a glance

  • Drugs Beclometasone/formoterol/glycopyrrolate (Primary) ; Beclometasone/formoterol
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms Trilogy
  • Sponsors Chiesi Farmaceutici SpA
  • Most Recent Events

    • 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
    • 23 May 2018 Results of safety pooled analysis using data from TRILOGY, TRINITY and TRIBUTE studies, presented at the 114th International Conference of the American Thoracic Society.
    • 24 Jul 2017 According to a Chiesi media release, the European Commission granted the marketing authorisation for Trimbow for the maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.
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