A randomized, double-blind, double-dummy, two-way cross-over study evaluating systemic bioavailability and airway clearance of Symbicort® Turbuhaler® 320/9μg/inhalation versus Seretide™ Diskus ™50/...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-002412-10

A randomized, double-blind, double-dummy, two-way cross-over study evaluating systemic bioavailability and airway clearance of Symbicort® Turbuhaler® 320/9μg/inhalation versus Seretide™ Diskus ™50/500μg/inhalation after single inhalations in patients with Chronic Obstructive Pulmonary Disease (COPD) and healthy volunteers

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Extrait

The primary objective is to evaluate airway tissue availability of budesonide via Symbicort Turbuhaler and fluticasone via Seretide Diskus in severe COPD patients and healthy volunteers, using area under the curve (AUC) of the plasma concentrations of the steroid components as surrogate marker.


Critère d'inclusion

  • This is a Clinical Pharmacology study to be conducted in one patient group with severe COPD and one group of healthy volunteers

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