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A 26 Week, Randomized, Double Blind, Multinational, Multicenter, Active Controlled, 2-arm Parallel Group Trial Comparing CHF 5993 100/6/12.5 μg pMDI (Fixed Combination of Extrafine Formulation of Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide) to CHF 1535 22/6 μg pMDI (Fixed Combination of Extrafine Formulation of Beclometasone Dipropionate Plus Formoterol Fumarate) in Subjects With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-Acting β2-Agonists

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Trial Profile

A 26 Week, Randomized, Double Blind, Multinational, Multicenter, Active Controlled, 2-arm Parallel Group Trial Comparing CHF 5993 100/6/12.5 μg pMDI (Fixed Combination of Extrafine Formulation of Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide) to CHF 1535 22/6 μg pMDI (Fixed Combination of Extrafine Formulation of Beclometasone Dipropionate Plus Formoterol Fumarate) in Subjects With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-Acting β2-Agonists

Status: Discontinued
Phase of Trial: Phase IV

Latest Information Update: 19 Nov 2024

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At a glance

  • Drugs Beclometasone/formoterol/glycopyrrolate (Primary) ; Beclometasone/formoterol; Corticosteroids; Formoterol; Salmeterol; Vilanterol
  • Indications Asthma
  • Focus Therapeutic Use
  • Acronyms MiSTIC
  • Sponsors Chiesi Farmaceutici SpA

Most Recent Events

  • 15 Nov 2024 Status changed from active, no longer recruiting to discontinued (The study was prematurely stopped due to extensive challenges in patient recruitment. The Sponsor issued a notification of early study termination to all investigational sites and all external stakeholders).
  • 30 May 2024 This trial has been completed in Poland, according to European Clinical Trials Database record.
  • 29 May 2024 This trial has been completed in Greece and Latvia, according to European Clinical Trials Database record.

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