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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01475032
Recruitment Status : Completed
First Posted : November 21, 2011
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: CHF 1535 Drug: Beclomethasone (BDP) Drug: Beclomethasone (BDP) + Formoterol Fumarate (FF) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 638 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : September 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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

Primary Outcome Measures :
  1. pre-dose FEV1 (forced expiratory volume in the first second) [ Time Frame: 12 weeks ]
    Assessment of lung function parameter as pre-dose FEV1

Secondary Outcome Measures :
  1. Patient with Asthma symptoms [ Time Frame: 12 weeks ]
    Patients with Asthma symptoms

  2. FVC (forced vital capacity) [ Time Frame: 12 weeks ]
    Assessment of lung function parameter as FVC

  3. Rescue medication use [ Time Frame: 12 weeks ]
    rescue medication used by the patient

  4. PEF (peak expiratory flow) [ Time Frame: 12 weeks ]
    Assessment of PEF as lung function parameter

  5. Number of patients with adverse events [ Time Frame: 12 weeks ]
    number of adverse event per patient

  6. Blood parameters [ Time Frame: at week 0 and week 12 ]
    Assessment of standard blood parameters (Hematology and chemistry)

  7. Heart rate [ Time Frame: 12 weeks ]
    Assessment of heart rate

  8. Blood pressure [ Time Frame: 12 weeks ]
    Assessment of blood pressure

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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01475032

UMHAT "Alexandrovska
Plovdiv, Bulgaria, 4002
Necker Enfants Malades Hospital
Paris, France, 75015
Drez. Gelb & Knecht
Bretten, Germany, 75015
Micro Care Kft
Szigetvár, Hungary, 7900
G.Gaslini Institute
Genoa, Italy, 16147
Uniwersytetu Medycznego
Łódź, Poland, 22 90-153
Spitalul Clinic Universitar de Urgenta Elias
Bucuresti, Romania, 011461
Russian Federation
Moscow State Medical University
Moscow, Russian Federation, 119435
NZZ- Detská pneumologická a ftizeologická ambulanci
Dolný Smokovec, Slovakia, 059 81
Hospital de Sabadell
Barcelona, Spain
Institute of Pediatrics
Kyiv, Ukraine, 04050
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Principal Investigator: Eugenio BARALDI, MD University of Padova - Italy

Additional Information:
Responsible Party: Chiesi Farmaceutici S.p.A. Identifier: NCT01475032     History of Changes
Other Study ID Numbers: CCD-0807-PR-0024
2009-016757-18 ( EudraCT Number )
First Posted: November 21, 2011    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by Chiesi Farmaceutici S.p.A.:
chronic treatment

Additional relevant MeSH terms:
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists