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

Study Identifier:
CCD-1012-PR-0051
ClinicalTrials.gov Identifier:
NCT01450774
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Asthma
Study Drug
  • Drug: CHF 1535 50/6µg
  • Drug: beclomethasone dipropionate 50µg + formoterol fumarate 6µg
Date
Sep 2011 - Nov 2013
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 5 - 11 Years
Requirements Information
Inclusion and Exclusion 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
Healthy Volunteers
No

Protocol 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.

Study Locations

Location
Status
Location
BørneAstmaKlinikken
Copenhagen, Denmark, 2100
Status
N/A