Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children
Phase 3
Completed
- Conditions
- Childhood Asthma
- Interventions
- Drug: beclomethasone dipropionate 50µg + formoterol fumarate 6µgDrug: CHF 1535 50/6µg
- Registration Number
- NCT01450774
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description beclomethasone dipropionate 50µg + formoterol fumarate 6µg beclomethasone dipropionate 50µg + formoterol fumarate 6µg - CHF 1535 50/6µg CHF 1535 50/6µg -
- Primary Outcome Measures
Name Time Method Lower leg growth rate measured by knemometry after a 2 week treatment
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
BørneAstmaKlinikken
🇩🇰Copenhagen, Denmark