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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
  Purpose

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.


Condition Intervention Phase
Childhood Asthma
 Drug: CHF 1535 50/6µg
Drug: beclomethasone dipropionate 50µg + formoterol fumarate 6µg
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Asthma Steroids
U.S. FDA Resources

Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Lower leg growth rate measured by knemometry [ Time Frame: after a 2 week treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CHF 1535 50/6µg Drug: CHF 1535 50/6µg
fixed combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
Active Comparator: beclomethasone dipropionate 50µg + formoterol fumarate 6µg Drug: beclomethasone dipropionate 50µg + formoterol fumarate 6µg
free combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg

  Eligibility

Ages Eligible for Study:   5 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450774

Contacts
Contact: Marisa Minetti +39 0521 279 715 m.minetti@chiesigroup.com

Locations
Denmark
BørneAstmaKlinikken Recruiting
Copenhagen, Denmark, 2100
Contact: Hans Bisgaard, MD     +45 26803090     Bisgaard@copsac.com    
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Hans Bisgaard, MD BørneAstmaKlinikken
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01450774     History of Changes
Other Study ID Numbers: CCD-1012-PR-0051
Study First Received: September 23, 2011
Last Updated: February 27, 2013
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Beclomethasone
Hydrocortisone
Formoterol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
 Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013