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A double-blind, placebo-controlled, clinical study examining the effect of QAW039 capsules on lung function and Astma control in non-atopic, asthmatic patients with a baseline lung function of 40-80% ...

Update Il y a 4 ans
Reference: EUCTR2012-003995-38

A double-blind, placebo-controlled, clinical study examining the effect of QAW039 capsules on lung function and Astma control in non-atopic, asthmatic patients with a baseline lung function of 40-80% predicted, inadequately controlled with low dose therapy with inhaled corticosteroids

Woman and Man

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Extract

The primary objective is to assess the efficacy of QAW039 (450 mg qd) compared to placebo with respect to the change in trough FEV1 from baseline to 12 weeks of post-baseline treatment in non-atopic asthmatic patients who, at randomization, were inadequately controlled on low dose ICS (100 μg fluticasone BID) background therapy.

Inclusion criteria

  • Moderate-to-severe, persistent asthma, inadequately controlled
  • with ICS therapy

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