Pharmacokinetic Clinical Study of CHF1535 NEXT DPI® Versus CHF1535 pMDI

Summary

The aim of this clinical study is to compare the lung exposure of the contents of the trial drug after administration of the fixed combination between beclomethasone and formoterol delivered via the new Chiesi dry powder inhaler in comparison to the beclomethasone and formoterol delivered via the pressurised metered dose inhaler (pMDI) using a spacer device. To determine lung exposure, the treatments are administered with charcoal block.

Timeline

Start

2011-05

Primary completion

2011-06

Completion

2011-06

Publications

• Results Govoni M, Piccinno A, Lucci G, Poli G, Acerbi D, Baronio R, Singh D, Kuna P, Chawes BL, Bisgaard H. The systemic exposure to inhaled beclometasone/formoterol pMDI with valved holding chamber is independent of age and body size. Pulm Pharmacol Ther. 2015 Feb;30:102-9. doi: 10.1016/j.pupt.2014.04.003. Epub 2014 Apr 16.

Drugs

Indications