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A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of ciclesonide metered-dose inhaler at a daily dose of 160 μg administered either in a once-dai...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-001248-30

A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of ciclesonide metered-dose inhaler at a daily dose of 160 μg administered either in a once-daily in the morning regimen (160 μg qd AM) for 16 weeks or in a 160 μg qd AM regimen for 12 weeks preceded by a twice-daily regimen (80 μg bid) for 4 weeks, or in an 80 μg bid regimen for 16 weeks, in adults and adolescents with mild to moderate persistent asthma not treated with steroids

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Extrait

To investigate the efficacy, compared to placebo, of ciclesonide at a daily dose of 160 μg administered either in a once-daily in the morning regimen (160 μg qd AM) for 16 weeks or in a 160 μg qd AM regimen for 12 weeks preceded by a twice-daily regimen (80 μg bid) for 4 weeks, or in an 80 μg bid regimen for 16 weeks, in adults and adolescents with mild to moderate persistent asthma not treated with steroids.

Critère d'inclusion

  • Asthma is a chronic inflammatory disease of the airways characterized by airway hyperresponsiveness, acute and chronic bronchoconstriction, airway edema, and mucus plugging. The inflammatory component of asthma is thought to involve many cell types including mast cells, eosinophils, T lymphocytes, neutrophils, and epithelial cells and their biologic products. Subjects with asthma most often present with symptoms of wheezing, shortness of breath, cough, and chest tightness

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