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: Completed; Phase 3

Conditions: Childhood Asthma

Treatments: Drug: beclomethasone dipropionate 50µg + formoterol fumarate 6µg; Drug: CHF 1535 50/6µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01450774

CCD-1012-PR-0051

Details and patient eligibility

About

This is a single centre, double-blind, double-dummy, randomised, single-centre, 2-way cross-over study in asthmatic children already treated with inhaled corticosteroids.

Enrollment: 72 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prepuberal male and female outpatients, ≥ 5 and ≤ 11 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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72 participants in 2 patient groups

CHF 1535 50/6µg

Experimental group

Treatment:

Drug: CHF 1535 50/6µg

beclomethasone dipropionate 50µg + formoterol fumarate 6µg

Active Comparator group

Treatment:

Drug: beclomethasone dipropionate 50µg + formoterol fumarate 6µg