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: 16 Aug 2017

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 Jul 2017 Status changed from active, no longer recruiting to completed.
    • 02 Oct 2016 Planned End Date changed from 1 Nov 2017 to 1 Jul 2017.
    • 30 Jun 2016 Planned primary completion date changed from 1 May 2017 to 1 Jul 2017.
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