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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 14 Mar 2018

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

    • 12 Feb 2018 Primary endpoint ( Moderate and severe COPD exacerbation rate over 52 weeks of treatment.) has been met, according to results published in the Lancet.
    • 12 Feb 2018 Results comparing a single-inhaler triple combination of beclometasone dipropionate, formoterol fumarate, and glycopyrronium (BDP/FF/G) versus a single-inhaler dual bronchodilator combination of indacaterol plus glycopyrronium (IND/GLY) in terms of the rate of moderate-to-severe COPD exacerbations over 52 weeks of treatment, were published in the Lancet.
    • 19 Jul 2017 Status changed from active, no longer recruiting to completed.
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