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

Asthma Clinical Trial

— PAED2/FRESH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475032
• Other study ID #: CCD-0807-PR-0024
• Secondary ID: 2009-016757-18
• Status: Completed
• Phase: Phase 3
• First received: October 11, 2011
• Last updated: March 28, 2017
• Start date: September 2011
• Est. completion date: September 2012

Study information

• Verified date: March 2017
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 638
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CHF 1535
CHF 1535 (BDP/FF) for 12 weeks
• Beclomethasone (BDP)
Beclomethasone (BDP) for 12 weeks
• Beclomethasone (BDP) + Formoterol Fumarate (FF)
free combo Beclomethasone (BDP) + FF for 12 weeks

Locations

Country	Name	City	State
Bulgaria	UMHAT "Alexandrovska	Plovdiv
France	Necker Enfants Malades Hospital	Paris
Germany	Drez. Gelb & Knecht	Bretten
Hungary	Micro Care Kft	Szigetvár
Italy	G.Gaslini Institute	Genoa
Poland	Uniwersytetu Medycznego	Lódz
Romania	Spitalul Clinic Universitar de Urgenta Elias	Bucuresti
Russian Federation	Moscow State Medical University	Moscow
Slovakia	NZZ- Detská pneumologická a ftizeologická ambulanci	Dolný Smokovec
Spain	Hospital de Sabadell	Barcelona
Ukraine	Institute of Pediatrics	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Countries where clinical trial is conducted

Bulgaria,  France,  Germany,  Hungary,  Italy,  Poland,  Romania,  Russian Federation,  Slovakia,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pre-dose FEV1 (forced expiratory volume in the first second)	Assessment of lung function parameter as pre-dose FEV1	12 weeks
Secondary	Patient with Asthma symptoms	Patients with Asthma symptoms	12 weeks
Secondary	FVC (forced vital capacity)	Assessment of lung function parameter as FVC	12 weeks
Secondary	Rescue medication use	rescue medication used by the patient	12 weeks
Secondary	PEF (peak expiratory flow)	Assessment of PEF as lung function parameter	12 weeks
Secondary	Number of patients with adverse events	number of adverse event per patient	12 weeks
Secondary	Blood parameters	Assessment of standard blood parameters (Hematology and chemistry)	at week 0 and week 12
Secondary	Heart rate	Assessment of heart rate	12 weeks
Secondary	Blood pressure	Assessment of blood pressure	12 weeks

External Links

•   Study Record on EU Clinical Trials Register including results