Single-Dose Clinical Pharmacology Study in Asthmatic Adolescent and Adult Patients

Summary

This clinical pharmacology want to investigate the systemic availability of BDP/B17MP (active metabolite of BDP) and formoterol after single oral inhalation of CHF 1535 100/6 pMDI with and without spacer device (AeroChamber Plus™) and in comparison to a free combination of BDP pMDI plus formoterol pMDI licensed products; this will be additionally compared to the systemic exposure in adults without the spacer device.

Timeline

Start

2012-02

Primary completion

2012-10

Completion

2012-10

Publications

• Results Kuna P, Govoni M, Lucci G, Scuri M, Acerbi D, Stelmach I. Pharmacokinetics and pharmacodynamics of an extrafine fixed pMDI combination of beclometasone dipropionate/formoterol fumarate in adolescent asthma. Br J Clin Pharmacol. 2015 Sep;80(3):569-80. doi: 10.1111/bcp.12640. Epub 2015 Jun 1.

Drugs

Indications