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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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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: 06 Nov 2021

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At a glance

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

    • Most Recent Events

    • 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.
    • 15 Feb 2016 Status changed from active, no longer recruiting to completed, as reported by ClinicalTrials.gov.

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