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A 12-WEEK, MULTINATIONAL, MULTICENTRE, RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, 2-ARM PARALLEL GROUP STUDY COMPARING THE EFFICACY AND SAFETY OF CHF 1535 200/6µg (FIXED COMBINATION BECLOMETHASONE DIPROPIONATE / FORMOTEROL) VERSUS BECLOMETHASONE DIPROPIONATE IN ADULTS ASTHMATIC PATIENTS NOT ADEQUATELY CONTROLLED ON HIGH DOSES OF INHALED CORTICOSTEROIDS OR ON MEDIUM DOSE OF INHALED CORTICOSTEROIDS PLUS LONG-ACTING BETA 2 AGONISTS.

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Trial Profile

A 12-WEEK, MULTINATIONAL, MULTICENTRE, RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, 2-ARM PARALLEL GROUP STUDY COMPARING THE EFFICACY AND SAFETY OF CHF 1535 200/6µg (FIXED COMBINATION BECLOMETHASONE DIPROPIONATE / FORMOTEROL) VERSUS BECLOMETHASONE DIPROPIONATE IN ADULTS ASTHMATIC PATIENTS NOT ADEQUATELY CONTROLLED ON HIGH DOSES OF INHALED CORTICOSTEROIDS OR ON MEDIUM DOSE OF INHALED CORTICOSTEROIDS PLUS LONG-ACTING BETA 2 AGONISTS.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Jul 2019

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At a glance

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

    • Most Recent Events

    • 14 Jul 2019 Trial has been completed in UK, according to European Clinical Trials Database record.
    • 12 Apr 2012 Additional lead trial investigator (Pierluigi Paggiaro) identified as reported by ClinicalTrials.gov.
    • 12 Apr 2012 Planned number of patients changed from 378 to 540 as reported by ClinicalTrials.gov.

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