Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children

Study Overview
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Brief Summary
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single center, double-blind, double-dummy, 2-way cross over study in asthmatic children already treated with inhaled corticosteroids

Official Title
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A SINGLE CENTRE, RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, 2-WAY CROSS OVER STUDY TO COMPARE SAFETY ASSESSED BY KNEMOMETRY AND URINARY CORTISOL MEASUREMENTS OF CHF1535 50/6 NEXThaler® (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE AND FORMOTEROL FUMARATE) AND THE FREE COMBINATION OF LICENSED BECLOMETHASONE DIPROPIONATE AND FORMOTEROL FUMARATE IN ASTHMATIC CHILDREN ALREADY TREATED WITH INHALED CORTICOSTEROIDS

Conditions
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Asthma in Children

Intervention / Treatment
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* Drug: combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
* Drug: free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prepuberal male and female outpatients, ≥ 5 and < 12 years old in Tanner stadium I according to Investigator's assessment; Clinical diagnosis of mild asthma during at least two months prior to screening visit; Forced Expiratory Volume during the first second (FEV1) > 80% of predicted normal values at screening visit; Exclusion Criteria: Endocrinological diseases including growth impairment or other chronic diseases; Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids;

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHF 1535 50/6 µg<br> | Drug: combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg<br>* beclomethasone dipropionate 50µg + formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks<br>|
| Active Comparator: beclomethasone dipropionate 100µg + Formoterol fumarate 6µg<br> | Drug: free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg<br>* beclomethasone dipropionate 100µg, 1 inhalation b.i.d. for 2 weeks and formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower Leg Growth rate measured by Knemometry |  | after 2 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour urinary free cortisol/creatinine levels |  | after 2 weeks of treatment | 
| Changes in pre-dose morning and evening PEF (L/min) |  | after 2 weeks of treatment |