Status:
COMPLETED
Efficacy Study of the Product "CHF 1535" Versus Beclomethasone (BDP) and Free Combo in Asthmatic Children
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Asthma
Eligibility:
All Genders
5-11 years
Phase:
PHASE3
Brief 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 Formotero...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
638 Patients enrolled
Trial Details
Trial ID
NCT01475032
Start Date
September 1 2011
End Date
September 1 2012
Last Update
March 29 2017
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
UMHAT "Alexandrovska
Plovdiv, Bulgaria, 4002
2
Necker Enfants Malades Hospital
Paris, France, 75015
3
Drez. Gelb & Knecht
Bretten, Germany, 75015
4
Micro Care Kft
Szigetvár, Hungary, 7900