drugset / Trial / NCT02119234

Pharmacokinetics of CHF 5993 pMDI With and Without Spacer in COPD Patients

NCT02119234

Phase 1 Completed 36 enrolled Chiesi Farmaceutici S.p.A.
RandomizedCrossoverOpen-labelTreatment

Summary

The study is performed to investigate the effect of the spacing device on the pharmacokinetics of CHF 5993 pMDI active ingredients administered with and without Aerochamber Plus Flow-vu antistatic VHC spacer as a single administration in COPD patients. Moreover, the general safety and tolerability of the treatments will be evaluated.

Timeline

Start
2014-03
Primary completion
2015-02
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Beclomethasone Small molecule 100 ug Inhaled
Subject Formoterol Other / unclassified 6 ug Inhaled
Subject Glycopyrrolate Small molecule 25 ug Inhaled