Efficacy Study of the Product "CHF 1535" Versus Beclomethasone (BDP) and Free Combo in Asthmatic Children (PAED2/FRESH)

Chiesi

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: CHF 1535; Drug: Beclomethasone (BDP) + Formoterol Fumarate (FF); Drug: Beclomethasone (BDP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01475032

CCD-0807-PR-0024

2009-016757-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 638 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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638 participants in 3 patient groups

CHF 1535

Experimental group

Description:

CHF 1535 (BDP/FF) for 12 weeks

Treatment:

Drug: CHF 1535

BDP

Active Comparator group

Description:

BDP for 12 weeks

Treatment:

Drug: Beclomethasone (BDP)

BDP+FF

Active Comparator group

Description:

free combo BDP+FF for 12 weeks

Treatment:

Drug: Beclomethasone (BDP) + Formoterol Fumarate (FF)