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A PHASE 4, MULTINATIONAL, MULTICENTRE, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, PARALLEL GROUP, CONTROLLED CLINICAL STUDY OF FIXED COMBINATION BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARAT...

Update Il y a 4 ans
Reference: EUCTR2008-003740-11

A PHASE 4, MULTINATIONAL, MULTICENTRE, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, PARALLEL GROUP, CONTROLLED CLINICAL STUDY OF FIXED COMBINATION BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg pMDI WITH HFA-134A PROPELLANT (CHF1535, FOSTER®) VERSUS FLUTICASONE 250 µg PLUS SALMETEROL 50 µg DPI (SERETIDE® DISKUS®) AS MAINTENANCE TREATMENT IN CONTROLLED ASTHMATIC PATIENTS

Woman and Man

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Extract

To demonstrate the equivalence in terms of FEV1 between CHF1535 (beclometasone dipropionate plus formoterol, 400/24 µg daily) and an equipotent dose of Seretide® Diskus® (fluticasone plus salmeterol, 500/100 µg /daily) in asthmatic patients already controlled on fluticasone plus salmeterol, 500/100 µg /daily.

Inclusion criteria

  • Asthma

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