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A SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSS-OVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 50/6 NEXT DPI® (FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE 50 µg PLUS FORMOTEROL FUMARATE 6 µg ) V...

Mise à jour : Il y a 4 ans
Référence : EUCTR2011-001208-36

A SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSS-OVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 50/6 NEXT DPI® (FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE 50 µg PLUS FORMOTEROL FUMARATE 6 µg ) VERSUS THE FREE COMBINATION OF LICENSED BECLOMETASONE DPI AND FORMOTEROL DPI IN ASTHMATIC CHILDREN

Femme et Homme

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Extrait

Primary: - To evaluate, in children, the systemic exposure to B17MP (active metabolite of BDP) as AUC0-t , after inhalation of CHF 1535 NEXT DPI® in comparison with a free combination of licensed BDP DPI and formoterol DPI.

Critère d'inclusion

  • Asthmatic children aged ≥ 5 and < 12 years,A part of the asthamatic children (8-10) must be in age range 5-8 years old in order to guarantee a complete representation

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