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A double blind, double dummy, randomised, multicentre, two arm parallel group study to assess the efficacy and safety of FlutiForm® pMDI 125/5 µg (2 puffs bid) vs Symbicort® Turbohaler® 200/6 µg (2 pu...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-017223-25

A double blind, double dummy, randomised, multicentre, two arm parallel group study to assess the efficacy and safety of FlutiForm® pMDI 125/5 µg (2 puffs bid) vs Symbicort® Turbohaler® 200/6 µg (2 puffs bid) in adolescent and adult subjects with moderate to severe persistent, reversible asthma

Femme et Homme

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Extrait

To show non-inferiority in the efficacy of FlutiForm® pMDI 125/5 µg (2 puffs bid) vs Symbicort® Turbohaler® 200/6 µg (2 puffs bid), based on the mean change in the pre-morning dose value of forced expiratory volume in the first second (FEV1) from baseline (end of run in period) to the end of the 12 week treatment period.

Critère d'inclusion

  • Asthma bronchial

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