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A Multicentre, Randomised, Double-blind, Placebo-controlled, 2-way Cross-over Study to Evaluate the Efficacy and Safety of CHF 5259 (Glycopyrrolate Bromide) pMDI on Top of QVAR® pMDI for the Treatment of Patients With Uncontrolled Asthma on Low-Medium Dose of Inhaled Corticosteroids.

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Trial Profile

A Multicentre, Randomised, Double-blind, Placebo-controlled, 2-way Cross-over Study to Evaluate the Efficacy and Safety of CHF 5259 (Glycopyrrolate Bromide) pMDI on Top of QVAR® pMDI for the Treatment of Patients With Uncontrolled Asthma on Low-Medium Dose of Inhaled Corticosteroids.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 21 May 2026

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At a glance

  • Drugs Glycopyrrolate (Primary)
  • Indications Asthma
  • Focus Therapeutic Use
  • Acronyms ELITRA
  • Sponsors Chiesi Farmaceutici

Most Recent Events

  • 22 Apr 2026 Actual primary completion date changed from 1 Aug 2015 to 13 Aug 2015.
  • 01 Feb 2021 According to a Chiesi Farmaceutici media release, the Marketing Authorisation approval is based on Committee for Medicinal Products for Human Uses positive opinion and European Commission approval on data obtained in four clinical studies involving close to 3000 patients (NCT02296411, NCT02676076, NCT02676089 and NCT02127866).
  • 01 Feb 2021 According to a Chiesi Farmaceutici media release, the European Commission has granted the marketing authorisation for Trimbow (beclometasone/formoterol/glycopyrronium), an extrafine formulation fixed triple combination therapy for the treatment of asthma.

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