Efficacy Study of the Product "CHF 1535" Versus Beclomethasone (BDP) and Free Combo in Asthmatic Children (PAED2/FRESH)

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: CHF 1535; Drug: Beclomethasone (BDP); Drug: Beclomethasone (BDP) + Formoterol Fumarate (FF)

• Study Type: Interventional
• Enrollment (Actual): 638
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • UMHAT "Alexandrovska
• France
  • Paris, France, 75015
    • Necker Enfants malades hospital
• Germany
  • Bretten, Germany, 75015
    • Drez. Gelb & Knecht
• Hungary
  • Szigetvár, Hungary, 7900
    • Micro Care Kft
• Italy
  • Genoa, Italy, 16147
    • G.Gaslini Institute
• Poland
  • Łódź, Poland, 22 90-153
    • Uniwersytetu Medycznego
• Romania
  • Bucuresti, Romania, 011461
    • Spitalul Clinic Universitar de Urgenta Elias
• Russian Federation
  • Moscow, Russian Federation, 119435
    • Moscow State Medical University
• Slovakia
  • Dolný Smokovec, Slovakia, 059 81
    • NZZ- Detská pneumologická a ftizeologická ambulanci
• Spain
  • Barcelona, Spain
    • Hospital de Sabadell
• Ukraine
  • Kyiv, Ukraine, 04050
    • Institute of Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CHF 1535; CHF 1535 (BDP/FF) for 12 weeks	Drug: CHF 1535; CHF 1535 (BDP/FF) for 12 weeks
ACTIVE_COMPARATOR: BDP; BDP for 12 weeks	Drug: Beclomethasone (BDP); Beclomethasone (BDP) for 12 weeks
ACTIVE_COMPARATOR: BDP+FF; free combo BDP+FF for 12 weeks	Drug: Beclomethasone (BDP) + Formoterol Fumarate (FF); free combo Beclomethasone (BDP) + FF for 12 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: Eugenio BARALDI, MD, University of Padova - Italy

Publications and helpful links

Helpful Links

• Study Record on EU Clinical Trials Register including results

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: October 11, 2011
• First Submitted That Met QC Criteria: November 18, 2011
• First Posted (ESTIMATE): November 21, 2011

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Asthma; children; chronic treatment
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Beclomethasone; Formoterol Fumarate
• Other Study ID Numbers: CCD-0807-PR-0024; 2009-016757-18 (EUDRACT_NUMBER)