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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 (...

Mise à jour : Il y a 4 ans
Référence : 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

Femme et Homme

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Extrait

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).

Critère d'inclusion

  • Moderate to severe asthma in adolescent patients

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