drugset / Trial / NCT01475032

Efficacy Study of the Product "CHF 1535" Versus Beclomethasone (BDP) and Free Combo in Asthmatic Children

NCT01475032

Phase 3 Completed 638 enrolled Chiesi Farmaceutici S.p.A.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to demonstrate that CHF 1535 in pressurized metered dose inhaler (pMDI) is non-inferior to the corresponding dose of free combination of Beclomethasone (BDP) and Formoterol Fumarate (FF) and superior to the corresponding dose of BDP in terms of lung functions in asthmatic children patients.

Timeline

Start
2011-09
Primary completion
2012-09
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject CHF1535 Unknown
Comparator Formoterol Other / unclassified
Comparator beclomethasone dipropionate Other / unclassified

Indications