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A SINGLE-DOSE, OPEN-LABEL, 2-WAY CROSS-OVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 50/6 HFA pMDI (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 50µg PLUS FORMOTEROL FUMARATE 6 µg ) USING THE AERO...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-010434-22

A SINGLE-DOSE, OPEN-LABEL, 2-WAY CROSS-OVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 50/6 HFA pMDI (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 50µg PLUS FORMOTEROL FUMARATE 6 µg ) USING THE AEROCHAMBER PLUS™ SPACER DEVICE VERSUS THE FREE COMBINATION OF BECLOMETHASONE HFA pMDI AND FORMOTEROL HFA pMDI AVAILABLE ON THE MARKET USING THE AEROCHAMBER PLUS™ SPACER DEVICE IN ASTHMATIC CHILDREN

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Extrait

Primary Objective(s). To evaluate, in children, the systemic exposure to B17MP (active metabolite of BDP) as AUC0-t , after inhalation of CHF 1535 pMDI 50/6 with spacer device in comparison with an already approved free combination of BDP pMDI and formoterol pMDI with spacer device.

Critère d'inclusion

  • Asthmatic children, aged 5-11, with a forced expiratory volume in one second (FEV1) > 70% of predicted values

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