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A phase II, multicentre, randomised, double-blind, double-dummy, active-controlled, 3-way cross-over study to evaluate the efficacy of CHF 5993 administered via Dry Powder Inhaler (DPI) versus CHF 5993 via pressurized Metered Dose Inhaler (pMDI) and CHF 1535 pMDI in patients with chronic obstructive pulmonary disease

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Trial Profile

A phase II, multicentre, randomised, double-blind, double-dummy, active-controlled, 3-way cross-over study to evaluate the efficacy of CHF 5993 administered via Dry Powder Inhaler (DPI) versus CHF 5993 via pressurized Metered Dose Inhaler (pMDI) and CHF 1535 pMDI in patients with chronic obstructive pulmonary disease

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 04 Nov 2021

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At a glance

  • Drugs Beclometasone/formoterol/glycopyrrolate (Primary) ; Beclometasone/formoterol; Beclometasone/formoterol/glycopyrrolate
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms Tri-D study
  • Sponsors Chiesi Farmaceutici

Most Recent Events

  • 21 Apr 2021 According to a Chiesi Group media release, based on the data of this study, the European Commission has granted the marketing authorisation for beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium inhalation powder delivered through NEXThaler for the maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination therapy.
  • 19 Mar 2019 Status changed from recruiting to completed.
  • 03 Mar 2019 The study has been completed in Czech Republic.

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