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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Beclomethasone (BDP); Drug: CHF 1535; Drug: Beclomethasone (BDP) + Formoterol Fumarate (FF)

• Registration Number: NCT01475032
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-11
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-21
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 638

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BDP	Beclomethasone (BDP)	BDP for 12 weeks
CHF 1535	CHF 1535	CHF 1535 (BDP/FF) for 12 weeks
BDP+FF	Beclomethasone (BDP) + Formoterol Fumarate (FF)	free combo BDP+FF for 12 weeks

Primary Outcome Measures

Name	Time	Method
pre-dose FEV1 (forced expiratory volume in the first second)	12 weeks	Assessment of lung function parameter as pre-dose FEV1

Secondary Outcome Measures

Name	Time	Method
Rescue medication use	12 weeks	rescue medication used by the patient
Patient with Asthma symptoms	12 weeks	Patients with Asthma symptoms
Number of patients with adverse events	12 weeks	number of adverse event per patient
Blood parameters	at week 0 and week 12	Assessment of standard blood parameters (Hematology and chemistry)
Blood pressure	12 weeks	Assessment of blood pressure
FVC (forced vital capacity)	12 weeks	Assessment of lung function parameter as FVC
PEF (peak expiratory flow)	12 weeks	Assessment of PEF as lung function parameter
Heart rate	12 weeks	Assessment of heart rate

Trial Locations

Locations (11)

Institute of Pediatrics; 🇺🇦 Kyiv, Ukraine

Spitalul Clinic Universitar de Urgenta Elias; 🇷🇴 Bucuresti, Romania

Moscow State Medical University; 🇷🇺 Moscow, Russian Federation

NZZ- Detská pneumologická a ftizeologická ambulanci; 🇸🇰 Dolný Smokovec, Slovakia

Hospital de Sabadell; 🇪🇸 Barcelona, Spain

G.Gaslini Institute; 🇮🇹 Genoa, Italy

Necker Enfants Malades Hospital; 🇫🇷 Paris, France

Drez. Gelb & Knecht; 🇩🇪 Bretten, Germany

UMHAT "Alexandrovska; 🇧🇬 Plovdiv, Bulgaria

Micro Care Kft; 🇭🇺 Szigetvár, Hungary

Uniwersytetu Medycznego; 🇵🇱 Łódź, Poland