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

This study is currently recruiting participants.
Verified February 2013 by Chiesi Farmaceutici S.p.A.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01450774
First received: September 23, 2011
Last updated: February 27, 2013
Last verified: February 2013
History of Changes

September 23, 2011
February 27, 2013
September 2011
January 2014   (final data collection date for primary outcome measure)
Lower leg growth rate measured by knemometry [ Time Frame: after a 2 week treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01450774 on ClinicalTrials.gov Archive Site
  • 24-hour urinary free cortisol/creatinine levels [ Time Frame: after a 2 week treatment period ] [ Designated as safety issue: Yes ]
  • Changes in pre-dose morning and evening PEF (L/min) [ Time Frame: pre and after a 2 week treatment period ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Childhood Asthma
  • Drug: CHF 1535 50/6µg
    fixed combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
  • Drug: beclomethasone dipropionate 50µg + formoterol fumarate 6µg
    free combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
  • Experimental: CHF 1535 50/6µg
    Intervention: Drug: CHF 1535 50/6µg
  • Active Comparator: beclomethasone dipropionate 50µg + formoterol fumarate 6µg
    Intervention: Drug: beclomethasone dipropionate 50µg + formoterol fumarate 6µg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
April 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
5 Years to 11 Years
No
Contact: Marisa Minetti +39 0521 279 715 m.minetti@chiesigroup.com
Denmark
 
NCT01450774
CCD-1012-PR-0051
No
Chiesi Farmaceutici S.p.A.
Chiesi Farmaceutici S.p.A.
Not Provided
Principal Investigator: Hans Bisgaard, MD BørneAstmaKlinikken
Chiesi Farmaceutici S.p.A.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP