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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: CHF 1535
* Drug: Beclomethasone (BDP)
* Drug: Beclomethasone (BDP) + Formoterol Fumarate (FF)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHF 1535<br>CHF 1535 (BDP/FF) for 12 weeks | Drug: CHF 1535<br>* CHF 1535 (BDP/FF) for 12 weeks<br>|
| Active Comparator: BDP<br>BDP for 12 weeks | Drug: Beclomethasone (BDP)<br>* Beclomethasone (BDP) for 12 weeks<br>|
| Active Comparator: BDP+FF<br>free combo BDP+FF for 12 weeks | Drug: Beclomethasone (BDP) + Formoterol Fumarate (FF)<br>* free combo Beclomethasone (BDP) + FF for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre-dose FEV1 (forced expiratory volume in the first second) | Assessment of lung function parameter as pre-dose FEV1 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient with Asthma symptoms | Patients with Asthma symptoms | 12 weeks | 
| FVC (forced vital capacity) | Assessment of lung function parameter as FVC | 12 weeks | 
| Rescue medication use | rescue medication used by the patient | 12 weeks | 
| PEF (peak expiratory flow) | Assessment of PEF as lung function parameter | 12 weeks | 
| Number of patients with adverse events | number of adverse event per patient | 12 weeks | 
| Blood parameters | Assessment of standard blood parameters (Hematology and chemistry) | at week 0 and week 12 | 
| Heart rate | Assessment of heart rate | 12 weeks | 
| Blood pressure | Assessment of blood pressure | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, children, chronic treatment