Clinical trial NCT01475032: Efficacy Study of the Product "CHF 1535" Versus Beclomethasone (BDP) and Free Combo in Asthmatic Children
Official title: A Phase III, 12-week, Multicentre, Multinational, Randomised, Double-blind, Double-dummy, 3 Arm-parallel Group Study to Test the Efficacy of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate (BDP) Plus Formoterol Fumarate (FF)) Versus a Free Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate and Versus a Monotherapy of Beclomethasone Dipropionate in Partly Controlled Asthmatic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
children
chronic treatment
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2011-11-21
Enrollment: 638
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Formoterol Fumarate (FF) and superior to the corresponding dose of BDP in terms of lung functions in asthmatic children patients.


Eligibility 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

Primary outcomes:
measure: pre-dose FEV1 (forced expiratory volume in the first second)
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient with Asthma symptoms
timeFrame: 12 weeks
measure: FVC (forced vital capacity)
timeFrame: 12 weeks
measure: Rescue medication use
timeFrame: 12 weeks
measure: PEF (peak expiratory flow)
timeFrame: 12 weeks
measure: Number of patients with adverse events
timeFrame: 12 weeks
measure: Blood parameters
timeFrame: at week 0 and week 12
measure: Heart rate
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: UMHAT "Alexandrovska
city: Paris
country: France
facility: Necker Enfants Malades Hospital
city: Bretten
country: Germany
facility: Drez. Gelb & Knecht
city: Szigetvár
country: Hungary
facility: Micro Care Kft
city: Genoa
country: Italy
facility: G.Gaslini Institute
city: Łódź
country: Poland
facility: Uniwersytetu Medycznego
city: Bucuresti
country: Romania
facility: Spitalul Clinic Universitar de Urgenta Elias
city: Moscow
country: Russian Federation
facility: Moscow State Medical University
city: Dolný Smokovec
country: Slovakia
facility: NZZ- Detská pneumologická a ftizeologická ambulanci
city: Barcelona
country: Spain
facility: Hospital de Sabadell
city: Kyiv
country: Ukraine
facility: Institute of Pediatrics
Study officials:
affiliation: University of Padova - Italy
name: Eugenio BARALDI, MD
role: PRINCIPAL_INVESTIGATOR
References: