Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-01-22 @ 12:45 PM
Study NCT ID:
NCT01475032
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2011-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of the Product "CHF 1535" Versus Beclomethasone (BDP) and Free Combo in Asthmatic Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001507', 'term': 'Beclomethasone'}, {'id': 'C048053', 'term': 'alpha-ketoisovalerate dehydrogenase phosphatase'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013258', 'term': 'Steroids, Chlorinated'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 638}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-28', 'studyFirstSubmitDate': '2011-10-11', 'studyFirstSubmitQcDate': '2011-11-18', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pre-dose FEV1 (forced expiratory volume in the first second)', 'timeFrame': '12 weeks', 'description': 'Assessment of lung function parameter as pre-dose FEV1'}], 'secondaryOutcomes': [{'measure': 'Patient with Asthma symptoms', 'timeFrame': '12 weeks', 'description': 'Patients with Asthma symptoms'}, {'measure': 'FVC (forced vital capacity)', 'timeFrame': '12 weeks', 'description': 'Assessment of lung function parameter as FVC'}, {'measure': 'Rescue medication use', 'timeFrame': '12 weeks', 'description': 'rescue medication used by the patient'}, {'measure': 'PEF (peak expiratory flow)', 'timeFrame': '12 weeks', 'description': 'Assessment of PEF as lung function parameter'}, {'measure': 'Number of patients with adverse events', 'timeFrame': '12 weeks', 'description': 'number of adverse event per patient'}, {'measure': 'Blood parameters', 'timeFrame': 'at week 0 and week 12', 'description': 'Assessment of standard blood parameters (Hematology and chemistry)'}, {'measure': 'Heart rate', 'timeFrame': '12 weeks', 'description': 'Assessment of heart rate'}, {'measure': 'Blood pressure', 'timeFrame': '12 weeks', 'description': 'Assessment of blood pressure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Asthma', 'children', 'chronic treatment'], 'conditions': ['Asthma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/search?query=2009-016757-18', 'label': 'Study Record on EU Clinical Trials Register including results'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female children (aged ≥ 5 and \\< 12 years)\n* Partly controlled asthma children according to Global Initiative for Asthma guidelines (GINA)\n* Symptomatic asthmatic patients treated with BDP up to 400 micrograms or equivalent\n* FEV1 ≥ 60% and ≤ 95% of predicted normal values\n\nExclusion Criteria:\n\n* Patients with two or more admissions to hospital for asthma exacerbation in the past 12 months or any admission to intensive care ever.\n* Occurrence of acute asthma exacerbations or lower respiratory tract infections in the 4 weeks before study entry\n* History of near fatal asthma\n* History of cystic fibrosis, bronchiectasis or primary ciliary dyskinesia\n* Diagnosis of restrictive lung disease.\n* Patients treated with systemic corticosteroids\n* Significant medical history and/or treatments'}, 'identificationModule': {'nctId': 'NCT01475032', 'acronym': 'PAED2/FRESH', 'briefTitle': 'Efficacy Study of the Product "CHF 1535" Versus Beclomethasone (BDP) and Free Combo in Asthmatic Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CCD-0807-PR-0024'}, 'secondaryIdInfos': [{'id': '2009-016757-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHF 1535', 'description': 'CHF 1535 (BDP/FF) for 12 weeks', 'interventionNames': ['Drug: CHF 1535']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BDP', 'description': 'BDP for 12 weeks', 'interventionNames': ['Drug: Beclomethasone (BDP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BDP+FF', 'description': 'free combo BDP+FF for 12 weeks', 'interventionNames': ['Drug: Beclomethasone (BDP) + Formoterol Fumarate (FF)']}], 'interventions': [{'name': 'CHF 1535', 'type': 'DRUG', 'description': 'CHF 1535 (BDP/FF) for 12 weeks', 'armGroupLabels': ['CHF 1535']}, {'name': 'Beclomethasone (BDP)', 'type': 'DRUG', 'description': 'Beclomethasone (BDP) for 12 weeks', 'armGroupLabels': ['BDP']}, {'name': 'Beclomethasone (BDP) + Formoterol Fumarate (FF)', 'type': 'DRUG', 'description': 'free combo Beclomethasone (BDP) + FF for 12 weeks', 'armGroupLabels': ['BDP+FF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4002', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'UMHAT "Alexandrovska', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Necker Enfants Malades Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Bretten', 'country': 'Germany', 'facility': 'Drez. Gelb & Knecht', 'geoPoint': {'lat': 49.03685, 'lon': 8.70745}}, {'zip': '7900', 'city': 'Szigetvár', 'country': 'Hungary', 'facility': 'Micro Care Kft', 'geoPoint': {'lat': 46.04865, 'lon': 17.80554}}, {'zip': '16147', 'city': 'Genoa', 'country': 'Italy', 'facility': 'G.Gaslini Institute', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': '22 90-153', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Uniwersytetu Medycznego', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '011461', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Spitalul Clinic Universitar de Urgenta Elias', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '119435', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Moscow State Medical University', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '059 81', 'city': 'Dolný Smokovec', 'country': 'Slovakia', 'facility': 'NZZ- Detská pneumologická a ftizeologická ambulanci', 'geoPoint': {'lat': 49.12697, 'lon': 20.25055}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Sabadell', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '04050', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Institute of Pediatrics', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}], 'overallOfficials': [{'name': 'Eugenio BARALDI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Padova - Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Farmaceutici S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}