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A 52 WEEK, RANDOMIZED, DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, ACTIVE CONTROLLED, 3-ARM PARALLEL GROUP TRIAL COMPARING CHF 5993 200/6/12.5 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE) TO CHF 1535 200/6 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE) ALONE OR ON TOP OF OPEN-LABEL TIOTROPIUM 2.5 µg RESPIMAT IN PATIENTS WITH ASTHMA UNCONTROLLED ON HIGH 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, 3-ARM PARALLEL GROUP TRIAL COMPARING CHF 5993 200/6/12.5 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE) TO CHF 1535 200/6 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE) ALONE OR ON TOP OF OPEN-LABEL TIOTROPIUM 2.5 µg RESPIMAT IN PATIENTS WITH ASTHMA UNCONTROLLED ON HIGH 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; Tiotropium bromide
  • Indications Acute asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms TRIGGER
  • 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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