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-1110-PR-0071
ClinicalTrials.gov Identifier:
NCT01658891
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Terminated/Withdrawn

Study Details

Medical Condition
  • Asthma
Study Drug
  • Drug: combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
  • Drug: free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg
Date
Feb 2014 - Nov 2015
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 \< 12 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

single center, double-blind, double-dummy, 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