Mobile

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 (...

Update Il y a 4 ans
Reference: EUCTR2007-000522-46

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 µg per actuation) 2 PUFFS BID VERSUS BDP HFA pMDI (250 µg per actuation) 2 PUFFS BID, IN ADOLESCENT PATIENTS WITH MODERATE TO SEVERE PERSISTENT ASTHMA

Woman and Man

  • | Country :
    • -
  • | organs :
    • -
  • | Specialty :
    • -

Extract

The primary objective of the study is to demonstrate the clinical superiority in terms of pulmonary function (change from baseline in pre-dose morning PEF) of CHF 1535 versus a corresponding, in terms of equipotency, dose of beclomethasone monotherapy in adolescent patients with partly controlled moderate to severe persistent asthma over a 12-week treatment period. The two study treatments will be administered via a pMDI standard actuator (without a spacing device).

Inclusion criteria

  • Moderate to severe asthma in adolescent patients

Links