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A multicenter, randomized, double-blind, double dummy, placebo controlled crossover study, to investigate the 24 hour FEV1 profile of a single dose of QMF Twisthaler® (500/400 μg o.d.) delivered in th...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-003192-39

A multicenter, randomized, double-blind, double dummy, placebo controlled crossover study, to investigate the 24 hour FEV1 profile of a single dose of QMF Twisthaler® (500/400 μg o.d.) delivered in the evening in adult patients with persistent asthma using fluticasone propionate/salmeterol (250/50 μg b.i.d.) as an active control

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Extrait

To evaluate bronchodilator effects of QMF Twisthaler® 500/400 μg o.d. (2x 250/200 μg) administered in the evening compared with placebo in terms of change from (period) baseline FEV1 to 24 hr post-dose trough FEV1 in patients with persistent asthma (The period baseline FEV1 is defined as the average of two FEV1 assessments taken at 50 min and 15 min before bthe study drug administration in that treatment period. 24 hr post-dose trough FEV1 is defined as the average of 2 FEV1 measurements at 23 hr 10 min and 23 hr 45 min post-dose).

Critère d'inclusion

  • Patients with persistent asthma, diagnosed according to GINA guidelines [National Institute of Health., National Heart, Lung and Blood Institute, 2006]

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