drugset / Trial / NCT01738087

Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder

NCT01738087

Phase 2 Completed 30 enrolled Chiesi Farmaceutici S.p.A.
RandomizedCrossoverOpen-labelTreatment

Summary

The study is aimed to assess the dose proportional total systemic exposure (when the administration is without the activated charcoal) to B17MP (active metabolite of BDP) and its lung bioavailability (when the administration is with the activated charcoal) after single inhalation of CHF 1535 NEXThaler DPI at two dose strengths. At the same time, the study will assess if the lung deposition and the total systemic exposure to Formoterol is affected by increasing doses of BDP.

Timeline

Start
2012-11
Primary completion
2013-01
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone propionate Other / unclassified 500 ug Inhaled
Subject Formoterol Other / unclassified 24 ug Inhaled
Subject beclomethasone dipropionate Other / unclassified 400 ug Inhaled
Subject beclomethasone dipropionate Other / unclassified 800 ug Inhaled

Indications