Status:
COMPLETED
Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Childhood Asthma
Eligibility:
All Genders
5-11 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- Endocrinological diseases including growth impairment or other chronic diseases
- Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01450774
Start Date
September 1 2011
End Date
February 1 2014
Last Update
March 29 2017
Active Locations (1)
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1
BørneAstmaKlinikken
Copenhagen, Denmark, 2100