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A 52 week, randomized, double blind, multinational, multicentre, active controlled, 2-arm parallel group trial comparing CHF 5993 100/6/12.5 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) to CHF 1535 100/6 µg pMDI (fixed combination of extrafine beclomethasone dipropionate plus formoterol fumarate) in patients with asthma uncontrolled on medium doses of inhaled corticosteroids in combination with long-acting ß2-agonists

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Trial Profile

A 52 week, randomized, double blind, multinational, multicentre, active controlled, 2-arm parallel group trial comparing CHF 5993 100/6/12.5 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) to CHF 1535 100/6 µg pMDI (fixed combination of extrafine beclomethasone dipropionate plus formoterol fumarate) in patients with asthma uncontrolled on medium doses of inhaled corticosteroids in combination with long-acting ß2-agonists

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jul 2023

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At a glance

  • Drugs Beclometasone/formoterol/glycopyrrolate (Primary) ; Beclometasone/formoterol
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms TRIMARAN
  • Sponsors Chiesi Farmaceutici

    • Most Recent Events

    • 24 May 2023 Results from TRIMARAN and TRIGGER, presented at the 119th International Conference of the American Thoracic Society.
    • 19 Jul 2022 Results of a pooled analysis of data from two 52-week clinical trials (TRIMARAN and TRIGGER) assessed the cost-effectiveness of single-inhaler extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium published in the Respiratory Medicine
    • 19 May 2021 Results of a post-hoc analysis of the TRIMARAN and TRIGGER studies to evaluate the relationship between Persistent airflow limitation (PAL) and the risk of moderate-severe exacerbations presented at the 117th International Conference of the American Thoracic Society
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