A Phase III, 12-week, Multicentre, Multinational, Randomised, Double-blind, Double-dummy, 3 Arm-parallel Group Study to Test the Efficacy of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate (BDP) Plus Formoterol Fumarate (FF)) Versus a Free Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate and Versus a Monotherapy of Beclomethasone Dipropionate in Partly Controlled Asthmatic Children.

Trial Profile

A Phase III, 12-week, Multicentre, Multinational, Randomised, Double-blind, Double-dummy, 3 Arm-parallel Group Study to Test the Efficacy of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate (BDP) Plus Formoterol Fumarate (FF)) Versus a Free Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate and Versus a Monotherapy of Beclomethasone Dipropionate in Partly Controlled Asthmatic Children.

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2017

At a glance

  • Drugs Beclometasone/formoterol (Primary) ; Beclometasone; Formoterol
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms PAED2/FRESH
  • Most Recent Events

    • 29 Dec 2012 Planned number of patients changed from 699 to 1000 as reported by European Clinical Trials Database.
    • 27 Jul 2012 Planned end date changed from 1 Oct 2012 to 1 Sep 2012 as reported by ClinicalTrials.gov record.
    • 27 Jul 2012 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov record.
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