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

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone; Formoterol Fumarate; Hydrocortisone

Criteria

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