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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01475032
First received: October 11, 2011
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Asthma
Drug: CHF 1535
Drug: Beclomethasone (BDP)
Drug: Beclomethasone (BDP) + Formoterol Fumarate (FF)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • pre-dose FEV1 (forced expiratory volume in the first second) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assessment of lung function parameter as pre-dose FEV1


Secondary Outcome Measures:
  • Patient with Asthma symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Patients with Asthma symptoms

  • FVC (forced vital capacity) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assessment of lung function parameter as FVC

  • Rescue medication use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    rescue medication used by the patient

  • PEF (peak expiratory flow) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assessment of PEF as lung function parameter

  • Number of patients with adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    number of adverse event per patient

  • Blood parameters [ Time Frame: at week 0 and week 12 ] [ Designated as safety issue: Yes ]
    Assessment of standard blood parameters (Hematology and chemistry)

  • Heart rate [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Assessment of heart rate

  • Blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Assessment of blood pressure


Enrollment: 638
Study Start Date: September 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   5 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475032

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

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01475032     History of Changes
Other Study ID Numbers: CCD-0807-PR-0024, 2009-016757-18
Study First Received: October 11, 2011
Last Updated: March 27, 2013
Health Authority: Bulgaria: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: Ministry of Health, Social and Family Affairs
Italy: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 22, 2014