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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01475032

Acronym

PAED2/FRESH

Enrollment

638

Registered

2011-11-21

Start date

2011-09-30

Completion date

2012-09-30

Last updated

2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, children, chronic 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.

Interventions

DRUGCHF 1535

CHF 1535 (BDP/FF) for 12 weeks

DRUGBeclomethasone (BDP)

Beclomethasone (BDP) for 12 weeks

DRUGBeclomethasone (BDP) + Formoterol Fumarate (FF)

free combo Beclomethasone (BDP) + FF for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to 11 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Bulgaria, France, Germany, Hungary, Italy, Poland, Romania, Russia, Slovakia, Spain, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026