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.
Phase of Trial: Phase III
Latest Information Update: 01 Apr 2017
At a glance
- Drugs Beclometasone/formoterol (Primary) ; Beclometasone; Formoterol
- Indications Asthma
- Focus Registrational; Therapeutic Use
- Acronyms PAED2/FRESH
- 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.