drugset / Trial / NCT01370031

Pilot Pharmacokinetic Clenil Study With AeroChamber Plus™ or Volumatic™ Spacer Devices

NCT01370031 ↗

Phase 2 Completed 16 enrolled Chiesi Farmaceutici S.p.A.
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is 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 or with charcoal block.

Timeline

Start
2011-04
Primary completion
2011-06
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Clenil® Modulite® via AeroChamber Plus™ Unknown 250 ug Other

Indications