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An exploratory, multi-centre, double-blind, placebo-controlled crossover study, to investigate the bronchodilatory efficacy of a single dose of indacaterol in fixed combination with mometasone furoate...

Update Il y a 4 ans
Reference: EUCTR2007-002360-10

An exploratory, multi-centre, double-blind, placebo-controlled crossover study, to investigate the bronchodilatory efficacy of a single dose of indacaterol in fixed combination with mometasone furoate delivered via a MDDPI (Twisthaler®) in adult patients with persistent asthma using open label Seretide® Accuhaler® (50/250 mcg b.i.d.) as an active control

Woman and Man

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Extract

To evaluate the bronchodilatory efficacy, in terms of trough FEV1, of indacaterol (500 μg) in combination with mometasone furoate (400 μg) delivered as 2 inhalations of QMF149 (indacaterol 250 μg/mometasone furoate 200 μg) via the Twisthaler ® versus matched QMF149 placebo in patients with persistent asthma. (Trough FEV1 is defined as the mean of 2 measurements at 23 h10 min and 23 h 45 min post-dose).

Inclusion criteria

  • Asthma

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