Efficacy Study of the Product "CHF 1535" Versus Beclomethasone (BDP) and Free Combo in Asthmatic Children (PAED2/FRESH)
This study has been completed.
Sponsor:
Chiesi Farmaceutici S.p.A.
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
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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:
MedlinePlus related topics:
Asthma
Drug Information available for:
Formic acid
Beclomethasone dipropionate
Formoterol fumarate
Formoterol
Beclomethasone dipropionate monohydrate
Arformoterol Tartrate
U.S. FDA Resources
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
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:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Beclomethasone Formoterol Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists 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 Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013