drugset / Trial / NCT01345916

Efficacy of CHF1535 Via NEXT DPI Versus pMDI and BDP DPI100µg on PeakExpiratoryFlow in Asthmatic Patients

NCT01345916

Phase 3 Completed 932 enrolled Chiesi Farmaceutici S.p.A.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to demonstrate that CHF 1535 NEXT DPI® is non-inferior to the corresponding dose of CHF 1535 pMDI and superior to marketed beclomethasone DPI 100 µg in terms of average pre-dose morning Peak Expiratory Flow (PEF) in asthmatic adult patients.

Timeline

Start
2011-03
Primary completion
2011-08
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Formoterol Other / unclassified 6 ug Inhaled
Subject beclomethasone dipropionate Other / unclassified 100 ug Inhaled

Indications