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Pilot, Open-Label, Randomised, Repeated Dose, 4-Way Cross-Over, Clinical Pharmacology Study of Beclomethasone Dipropionate (Clenil® Modulite®) 250 µg HFA PMDI using the Aerochamber Plus™ Spacer Device...

Update Il y a 4 ans
Reference: EUCTR2010-022615-19

Pilot, Open-Label, Randomised, Repeated Dose, 4-Way Cross-Over, Clinical Pharmacology Study of Beclomethasone Dipropionate (Clenil® Modulite®) 250 µg HFA PMDI using the Aerochamber Plus™ Spacer Device Versus The Volumatic™ Spacer Device Without or With Charcoal Block in Asthmatic Adult Patients

Woman and Man

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Extract

To evaluate, at steady-state, the systemic exposure and the lung deposition of B17MP (active metabolite of BDP) as AUC0-12h,ss and Cmax,ss, after inhalation of BDP (Clenil® Modulite®) with the AeroChamber Plus™ spacer device or with the Volumatic™ spacer device without and with charcoal block.

Inclusion criteria

  • Asthma

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