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A 24-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 the Fixed Combination of Budesonide Plus Formoterol Fumarate (Symbicort Turbuhaler) in Patients With Chronic Obstructive Pulmonary Disease

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Trial Profile

A 24-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 the Fixed Combination of Budesonide Plus Formoterol Fumarate (Symbicort Turbuhaler) in Patients With Chronic Obstructive Pulmonary Disease

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 05 Nov 2021

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At a glance

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

    • Most Recent Events

    • 21 Oct 2020 Results presented at the CHEST Annual Meeting 2020 by Annual Meeting of the American College of Chest Physicians
    • 20 May 2020 An independent data monitoring committee reviewed efficacy and safety data from the prospectively planned interim analysis and recommended early recruitment termination based on demonstration of superiority in all primary endpoints as per interim results presented at the 116th International Conference of the American Thoracic Society.
    • 20 May 2020 Primary endpoint (Change from Baseline in 2-hour post-dose FEV1 at week 24) has been met as per the interim results presented at the 116th International Conference of the American Thoracic Society.
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