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A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED, 3-WAY CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A FREE COMBINATION OF 3 DOSES OF CHF 5259 (GLYCOPYRROLATE) PLUS FOSTER 100/6 µg (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL) IN A METERED DOSE INHALER FOR THE TREATMENT OF PATIENTS WITH UNCONTROLLED ASTHMA UNDER MEDIUM DOSES OF INHALED CORTICOSTEROIDS PLUS LONG-ACTING β2-AGONISTS

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Trial Profile

A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED, 3-WAY CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A FREE COMBINATION OF 3 DOSES OF CHF 5259 (GLYCOPYRROLATE) PLUS FOSTER 100/6 µg (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL) IN A METERED DOSE INHALER FOR THE TREATMENT OF PATIENTS WITH UNCONTROLLED ASTHMA UNDER MEDIUM DOSES OF INHALED CORTICOSTEROIDS PLUS LONG-ACTING β2-AGONISTS

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 09 Feb 2021

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At a glance

  • Drugs Glycopyrrolate (Primary) ; Beclometasone/formoterol
  • Indications Asthma
  • Focus Therapeutic Use
  • Acronyms Triskel
  • Sponsors Chiesi Farmaceutici SpA

    • Most Recent Events

    • 09 Feb 2021 New trial record
    • 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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