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

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.

Inclusion Criteria:

• Male and female children (aged ≥ 5 and < 12 years)
• Partly controlled asthma children according to Global Initiative for Asthma guidelines (GINA)
• Symptomatic asthmatic patients treated with BDP up to 400 micrograms or equivalent
• FEV1 ≥ 60% and ≤ 95% of predicted normal values

Exclusion Criteria:

• Patients with two or more admissions to hospital for asthma exacerbation in the past 12 months or any admission to intensive care ever.
• Occurrence of acute asthma exacerbations or lower respiratory tract infections in the 4 weeks before study entry
• History of near fatal asthma
• History of cystic fibrosis, bronchiectasis or primary ciliary dyskinesia
• Diagnosis of restrictive lung disease.
• Patients treated with systemic corticosteroids
• Significant medical history and/or treatments