Efficacy and safety of Symbicort® Turbuhaler® 160/4.5 µg/inhalation, two inhalations twice daily plus as-needed compared with Seretide™ Diskus™ 50/500 µg/inhalation, one inhalation twice daily plus te...

Mise à jour : Il y a 4 ans
Référence : EUCTR2004-004905-11

Efficacy and safety of Symbicort® Turbuhaler® 160/4.5 µg/inhalation, two inhalations twice daily plus as-needed compared with Seretide™ Diskus™ 50/500 µg/inhalation, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg/inhalation as-needed - a 6-month randomised, double-blind, parallel-group, active controlled, multinational phase IIIB study in adult and adolescent patients with persistent asthma

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Extrait

The primary objective of this study is to compare the efficacy of two inhalations of Symbicort Turbuhaler 160/4.5 µg/inhalation twice daily plus Symbicort Turbuhaler 160/4.5 µg/inhalation as-needed, with one inhalation of Seretide Diskus 50/500 µg/inhalation twice daily plus terbutaline Turbuhaler 0.4 mg/inhalation as-needed in patients with persistent asthma by evaluation of time to first severe asthma exacerbation as the primary outcome variable.


Critère d'inclusion

  • This is a Phase IIIB study to be performed in adult and adolescent asthmatic patients