A 52-week, Double Blind, Double dummy, Randomized, Multinational, Multicentre, 3-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 tiotropium bromide and versus fixed combination of beclometasone dipropionate plus formoterol fumarate administered via pMDI and tiotropium bromide in patients with Chronic Obstructive Pulmonary Disease

Trial Profile

A 52-week, Double Blind, Double dummy, Randomized, Multinational, Multicentre, 3-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 tiotropium bromide and versus fixed combination of beclometasone dipropionate plus formoterol fumarate administered via pMDI and tiotropium bromide in patients with Chronic Obstructive Pulmonary Disease

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Sep 2017

At a glance

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

    • 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.
    • 24 May 2017 Results of extrafine fixed triple therapy FEV1 responders presented at the 113th International Conference of the American Thoracic Society
    • 24 May 2017 Results presented at the 113th International Conference of the American Thoracic Society
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