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

NCT ID: NCT01475032

Last Updated: 2017-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

638 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CHF 1535

CHF 1535 (BDP/FF) for 12 weeks

Group Type EXPERIMENTAL

CHF 1535

Intervention Type DRUG

CHF 1535 (BDP/FF) for 12 weeks

BDP

BDP for 12 weeks

Group Type ACTIVE_COMPARATOR

Beclomethasone (BDP)

Intervention Type DRUG

Beclomethasone (BDP) for 12 weeks

BDP+FF

free combo BDP+FF for 12 weeks

Group Type ACTIVE_COMPARATOR

Beclomethasone (BDP) + Formoterol Fumarate (FF)

Intervention Type DRUG

free combo Beclomethasone (BDP) + FF for 12 weeks

Interventions

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CHF 1535

CHF 1535 (BDP/FF) for 12 weeks

Intervention Type DRUG

Beclomethasone (BDP)

Beclomethasone (BDP) for 12 weeks

Intervention Type DRUG

Beclomethasone (BDP) + Formoterol Fumarate (FF)

free combo Beclomethasone (BDP) + FF for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eugenio BARALDI, MD

Role: PRINCIPAL_INVESTIGATOR

University of Padova - Italy

Locations

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UMHAT "Alexandrovska

Plovdiv, , Bulgaria

Site Status

Necker Enfants Malades Hospital

Paris, , France

Site Status

Drez. Gelb & Knecht

Bretten, , Germany

Site Status

Micro Care Kft

Szigetvár, , Hungary

Site Status

G.Gaslini Institute

Genoa, , Italy

Site Status

Uniwersytetu Medycznego

Lodz, , Poland

Site Status

Spitalul Clinic Universitar de Urgenta Elias

Bucharest, , Romania

Site Status

Moscow State Medical University

Moscow, , Russia

Site Status

NZZ- Detská pneumologická a ftizeologická ambulanci

Dolný Smokovec, , Slovakia

Site Status

Hospital de Sabadell

Barcelona, , Spain

Site Status

Institute of Pediatrics

Kyiv, , Ukraine

Site Status

Countries

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Bulgaria France Germany Hungary Italy Poland Romania Russia Slovakia Spain Ukraine

Related Links

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https://www.clinicaltrialsregister.eu/ctr-search/search?query=2009-016757-18

Study Record on EU Clinical Trials Register including results

Other Identifiers

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2009-016757-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CCD-0807-PR-0024

Identifier Type: -

Identifier Source: org_study_id

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