NCT01450774
Completed
Phase 3
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 Pmdi (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
ConditionsChildhood Asthma
Overview
- Phase
- Phase 3
- Intervention
- CHF 1535 50/6µg
- Conditions
- Childhood Asthma
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Lower leg growth rate measured by knemometry
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility 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
Arms & Interventions
CHF 1535 50/6µg
Intervention: CHF 1535 50/6µg
beclomethasone dipropionate 50µg + formoterol fumarate 6µg
Intervention: beclomethasone dipropionate 50µg + formoterol fumarate 6µg
Outcomes
Primary Outcomes
Lower leg growth rate measured by knemometry
Time Frame: after a 2 week treatment
Secondary Outcomes
- 24-hour urinary free cortisol/creatinine levels(after a 2 week treatment period)
- Changes in pre-dose morning and evening PEF (L/min)(pre and after a 2 week treatment period)
Study Sites (1)
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