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A randomized, multi-center, parallel group, double-blind, placebo and formetrol controlled 14 day dose ranging trial of 4 doses of indacaterol delivered via Twisthaler®, in adult and adolescent patie...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-003191-19

A randomized, multi-center, parallel group, double-blind, placebo and formetrol controlled 14 day dose ranging trial of 4 doses of indacaterol delivered via Twisthaler®, in adult and adolescent patients with persistent asthma

Femme et Homme

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Extrait

To evaluate the dose response relationship among four doses of indacaterol Twisthaler® (62.5, 125, 250, and 500 μg o.d.) and placebo as measured by the mean change from baseline to 24 hr post-dose of (trough) FEV1 after 14 days of treatment. (Baseline FEV1 is defined as the average of two FEV1 assessments taken at 50 min and 15 min before the first study drug administration. Trough FEV1 is defined as the mean of 2 measurements at 23 hr 10 min and 23 hr 45 min post-dose).

Critère d'inclusion

  • Persistent asthma

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