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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...

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Reference: 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

Woman and Man

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Extract

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.

Inclusion criteria

  • Persistent asthma

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