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A double blind, double dummy, randomised, multicentre, four arm parallel group study to assess the efficacy and safety of FlutiForm™ pMDI 250/10 µg (2 puffs bid) vs Fluticasone pMDI 250 µg (2 puffs bi...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-001633-34

A double blind, double dummy, randomised, multicentre, four arm parallel group study to assess the efficacy and safety of FlutiForm™ pMDI 250/10 µg (2 puffs bid) vs Fluticasone pMDI 250 µg (2 puffs bid) plus Formoterol pMDI 12 µg (2 puffs bid) administered concurrently in adult subjects with severe persistent, reversible asthma

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Extrait

To show non-inferiority in the efficacy of FlutiForm pMDI 250/10 µg (2 puffs bid) vs Fluticasone pMDI 250 µg (2 puffs bid) plus Formoterol pMDI 12 µg (2 puffs bid) administered concurrently, 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 8 week treatment period. The co-primary endpoint of this study is: To show non-inferiority in the efficacy of FlutiForm pMDI 250/10 μg (2 puffs bid) vs Fluticasone pMDI 250 μg (2 puffs bid) plus Formoterol pMDI 12 μg (2 puffs bid) administered concurrently, based on the mean change from the pre morning dose FEV1 value at baseline (end of run-in period) to the 2 hour post morning dose FEV1 value at the end of the 8 week treatment period.

Critère d'inclusion

  • Asthma bronchial

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