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.

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Apr 2017

At a glance

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

    • 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.
    • 12 Apr 2012 New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health; NCT01577082).
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