Efficacy Study of the Product "CHF 1535" Versus Beclomethasone (BDP) and Free Combo in Asthmatic Children

Study Identifier:
CCD-0807-PR-0024
ClinicalTrials.gov Identifier:
NCT01475032
EudraCT Identifier:
2009-016757-18
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Asthma
Study Drug
  • Drug: CHF 1535
  • Drug: Beclomethasone (BDP)
  • Drug: Beclomethasone (BDP) + Formoterol Fumarate (FF)
Date
Sep 2011 - Sep 2012
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
  • Male and female children (aged ≥ 5 and \< 12 years)
  • Partly controlled asthma children according to Global Initiative for Asthma guidelines (GINA)
  • Symptomatic asthmatic patients treated with BDP up to 400 micrograms or equivalent
  • FEV1 ≥ 60% and ≤ 95% of predicted normal values
Exclusion Criteria
  • Patients with two or more admissions to hospital for asthma exacerbation in the past 12 months or any admission to intensive care ever.
  • Occurrence of acute asthma exacerbations or lower respiratory tract infections in the 4 weeks before study entry
  • History of near fatal asthma
  • History of cystic fibrosis, bronchiectasis or primary ciliary dyskinesia
  • Diagnosis of restrictive lung disease.
  • Patients treated with systemic corticosteroids
  • Significant medical history and/or treatments
Healthy Volunteers
No

Protocol Summary

The purpose of this study is to demonstrate that CHF 1535 in pressurized metered dose inhaler (pMDI) is non-inferior to the corresponding dose of free combination of Beclomethasone (BDP) and Formoterol Fumarate (FF) and superior to the corresponding dose of BDP in terms of lung functions in asthmatic children patients.

Study Locations

Location
Status
Location
UMHAT "Alexandrovska
Plovdiv, Bulgaria, 4002
Status
N/A
Location
Necker Enfants Malades Hospital
Paris, France, 75015
Status
N/A
Location
Drez. Gelb & Knecht
Bretten, Germany, 75015
Status
N/A
Location
Micro Care Kft
Szigetvár, Hungary, 7900
Status
N/A
Location
G.Gaslini Institute
Genoa, Italy, 16147
Status
N/A
Location
Uniwersytetu Medycznego
Lodz, Poland, 22 90-153
Status
N/A
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