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A multi-centre, randomized, double-blind, placebo controlled, multiple-dose, 4-way cross-over study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally inhaled indacaterol sa...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-010589-46

A multi-centre, randomized, double-blind, placebo controlled, multiple-dose, 4-way cross-over study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally inhaled indacaterol salts (maleate, xinafoate and acetate) in patients with persistent asthma

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Extrait

To assess the bronchodilator effect of orally inhaled indacaterol salts (maleate, xinafoate and acetate) in patients with persistent asthma compared with placebo as measured by mean change in FEV1 from baseline to post-dose trough after 7 days of treatment. Trough is defined as the mean of FEV1 at 23 h 10 min and 23 h 45 min post-dose.

Critère d'inclusion

  • Persistent asthma

Liens