A 12-WEEK, MULTICENTER, MULTINATIONAL, RANDOMISED, DOUBLE BLIND, DOUBLE-DUMMY (OPEN LABEL FOR THE SPACER GROUP), 3-ARM PARALLEL GROUP STUDY COMPARING THE EFFICACY AND THE SAFETY OF CHF 1535 HFA pMDI (BDP/FF 100/6 microg per actuation) 2 PUFFS BID VERSUS BDP HFA pMDI (250 microg per actuation) 2 PUFFS BID, IN ADOLESCENT PATIENTS WITH MODERATE TO SEVERE PERSISTENT ASTHMA.

Trial Profile

A 12-WEEK, MULTICENTER, MULTINATIONAL, RANDOMISED, DOUBLE BLIND, DOUBLE-DUMMY (OPEN LABEL FOR THE SPACER GROUP), 3-ARM PARALLEL GROUP STUDY COMPARING THE EFFICACY AND THE SAFETY OF CHF 1535 HFA pMDI (BDP/FF 100/6 microg per actuation) 2 PUFFS BID VERSUS BDP HFA pMDI (250 microg per actuation) 2 PUFFS BID, IN ADOLESCENT PATIENTS WITH MODERATE TO SEVERE PERSISTENT ASTHMA.

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2017

At a glance

  • Drugs Beclometasone; Beclometasone/formoterol
  • Indications Asthma
  • Focus Therapeutic Use
  • Sponsors Chiesi Farmaceutici
  • Most Recent Events

    • 30 May 2012 Actual initiation date changed from 9 Aug 2007 to 11 Jul 2007 as reported by European Clinical Trials Database record.
    • 09 Aug 2011 New trial record
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