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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CHF 1535
Beclomethasone (BDP)
Beclomethasone (BDP) + Formoterol Fumarate (FF)
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, children, chronic treatment

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • UMHAT "Alexandrovska
  • Necker Enfants Malades Hospital
  • Drez. Gelb & Knecht
  • Micro Care Kft
  • G.Gaslini Institute
  • Uniwersytetu Medycznego
  • Spitalul Clinic Universitar de Urgenta Elias
  • Moscow State Medical University
  • NZZ- Detská pneumologická a ftizeologická ambulanci
  • Hospital de Sabadell
  • Institute of Pediatrics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

CHF 1535

BDP

BDP+FF

Arm Description

CHF 1535 (BDP/FF) for 12 weeks

BDP for 12 weeks

free combo BDP+FF for 12 weeks

Outcomes

Primary Outcome Measures

pre-dose FEV1 (forced expiratory volume in the first second)
Assessment of lung function parameter as pre-dose FEV1

Secondary Outcome Measures

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

Full Information

First Posted
October 11, 2011
Last Updated
March 28, 2017
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01475032
Brief Title
Efficacy Study of the Product "CHF 1535" Versus Beclomethasone (BDP) and Free Combo in Asthmatic Children
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, children, chronic treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
638 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHF 1535
Arm Type
Experimental
Arm Description
CHF 1535 (BDP/FF) for 12 weeks
Arm Title
BDP
Arm Type
Active Comparator
Arm Description
BDP for 12 weeks
Arm Title
BDP+FF
Arm Type
Active Comparator
Arm Description
free combo BDP+FF for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CHF 1535
Intervention Description
CHF 1535 (BDP/FF) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Beclomethasone (BDP)
Intervention Description
Beclomethasone (BDP) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Beclomethasone (BDP) + Formoterol Fumarate (FF)
Intervention Description
free combo Beclomethasone (BDP) + FF for 12 weeks
Primary Outcome Measure Information:
Title
pre-dose FEV1 (forced expiratory volume in the first second)
Description
Assessment of lung function parameter as pre-dose FEV1
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Patient with Asthma symptoms
Description
Patients with Asthma symptoms
Time Frame
12 weeks
Title
FVC (forced vital capacity)
Description
Assessment of lung function parameter as FVC
Time Frame
12 weeks
Title
Rescue medication use
Description
rescue medication used by the patient
Time Frame
12 weeks
Title
PEF (peak expiratory flow)
Description
Assessment of PEF as lung function parameter
Time Frame
12 weeks
Title
Number of patients with adverse events
Description
number of adverse event per patient
Time Frame
12 weeks
Title
Blood parameters
Description
Assessment of standard blood parameters (Hematology and chemistry)
Time Frame
at week 0 and week 12
Title
Heart rate
Description
Assessment of heart rate
Time Frame
12 weeks
Title
Blood pressure
Description
Assessment of blood pressure
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugenio BARALDI, MD
Organizational Affiliation
University of Padova - Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMHAT "Alexandrovska
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Necker Enfants Malades Hospital
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Drez. Gelb & Knecht
City
Bretten
ZIP/Postal Code
75015
Country
Germany
Facility Name
Micro Care Kft
City
Szigetvár
ZIP/Postal Code
7900
Country
Hungary
Facility Name
G.Gaslini Institute
City
Genoa
ZIP/Postal Code
16147
Country
Italy
Facility Name
Uniwersytetu Medycznego
City
Łódź
ZIP/Postal Code
22 90-153
Country
Poland
Facility Name
Spitalul Clinic Universitar de Urgenta Elias
City
Bucuresti
ZIP/Postal Code
011461
Country
Romania
Facility Name
Moscow State Medical University
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
Facility Name
NZZ- Detská pneumologická a ftizeologická ambulanci
City
Dolný Smokovec
ZIP/Postal Code
059 81
Country
Slovakia
Facility Name
Hospital de Sabadell
City
Barcelona
Country
Spain
Facility Name
Institute of Pediatrics
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine

12. IPD Sharing Statement

Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2009-016757-18
Description
Study Record on EU Clinical Trials Register including results

Learn more about this trial

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

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