NCT01475032

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

A Phase III, 12-week, Multicentre, Multinational, Randomised, Double-blind, Double-dummy, 3 Arm-parallel Group Study to Test the Efficacy of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate (BDP) Plus Formoterol Fumarate (FF)) Versus a Free Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate and Versus a Monotherapy of Beclomethasone Dipropionate in Partly Controlled Asthmatic Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 638 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 5 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	CHF 1535	CHF 1535 (BDP/FF) for 12 weeks
DRUG	Beclomethasone (BDP)	Beclomethasone (BDP) for 12 weeks
DRUG	Beclomethasone (BDP) + Formoterol Fumarate (FF)	free combo Beclomethasone (BDP) + FF for 12 weeks

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-11-21
• Last updated: 2017-03-29

Locations

11 sites across 11 countries: Bulgaria, France, Germany, Hungary, Italy, Poland, Romania, Russia, Slovakia, Spain, Ukraine