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

Chiesi

Status and phase: Withdrawn; Phase 3

Conditions: Asthma in Children

Treatments: Drug: free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg; Drug: combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01658891

CCD-1110-PR-0071

Details and patient eligibility

About

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

Sex: All

Ages: 5 to 11 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

CHF 1535 50/6 µg

Experimental group

Treatment:

Drug: combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg

beclomethasone dipropionate 100µg + Formoterol fumarate 6µg

Active Comparator group

Treatment:

Drug: free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg