Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-03 @ 12:38 AM
Study NCT ID:
NCT02114034
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-15
First Post:
2013-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort Analysis of Clinical and Biological Severe Childhood Asthma
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* whole blood\n* serum\n* Bronchoalveolar lavage fluid\n* bronchial brushing and washing specimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 362}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2032-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2013-08-22', 'studyFirstSubmitQcDate': '2014-04-14', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2032-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The identification of risk factors for severe asthma', 'timeFrame': '18 years', 'description': 'A prospective follow-up of a cohort of severe pediatric asthma. To improve the identification of risk factors for severe asthma, a group of children with non-severe asthma will also be included'}], 'secondaryOutcomes': [{'measure': 'In the medium and longer term assessment', 'timeFrame': '4 years', 'description': '* Identify the functional and clinical outcome in a longitudinal follow-up to a link with asthma in adults.\n* Identify the factors involved appearing during growth or adulthood (pediatric factors associated with severe asthma profile adult).'}, {'measure': 'A short-term assessment', 'timeFrame': '4 years', 'description': '* Identify the main phenotypes of severe asthma by the cluster analysis\n* Identify the factors involved in severity during childhood'}, {'measure': 'Establish a collection of biological samples (serum bank, DNA Bank, tissue Bank) to search for biomarkers of severity and genetic risk factors for the development of asthma in children.', 'timeFrame': '18 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Severe asthma,', 'child,', 'outcome,'], 'conditions': ['Severe Asthma']}, 'referencesModule': {'references': [{'pmid': '33359443', 'type': 'BACKGROUND', 'citation': 'Lezmi G, Lejeune S, Pin I, Blanchon S, Bouazza N, Jolaine V, Marguet C, Houdoin V, Berger P, Fayon M, Dubus JC, Reix P, Pellan M, Brouard J, Chiron R, Giovannini-Chami L, Deschildre A, de Blic J; COBRAPed Study Group. Factors Associated with Asthma Severity in Children: Data from the French COBRAPed Cohort. J Allergy Clin Immunol Pract. 2021 May;9(5):1969-1979. doi: 10.1016/j.jaip.2020.12.027. Epub 2020 Dec 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective study is:\n\n* to identify by cluster analysis the main phenotypes of severe asthma and factors involved in the severity,\n* to determine the clinical and functional outcomes,\n* to identify the factors associated with severe asthma from childhood to adulthood.', 'detailedDescription': 'Severe asthma involves about 5 % of asthmatic children and is associated with a high impact on hospitalizations, absenteeism and quality of life.\n\nAlthough our knowledge has progressed in a substantial way during the last ten years, a number of unresolved questions persist in particular as regard to the contributing factors and outcomes from early childhood to adulthood.\n\nAfter parental agreement the following elements will be collected at inclusion: clinical environmental data, pulmonary function, allergy test data (skin prick tests and specific IgE), blood and serum samples for biobank (DNA / SERUM). In a restricted number of children a more extensive work up will be performed which may include flexible bronchoscopy, bronchial brushing and bronchoalveolar lavage.\n\nThe follow-up will be performed every 6 months within the framework of the usual care including collection of clinical data and pulmonary function tests. The allergic status will be done again at 6-7 years, 12 years and 18 years.\n\nIn the group of children having non-severe asthma, the follow-up will be annual with collection of clinical data and pulmonary function tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary Care Clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren with severe asthma:\n\n* Child aged 3 to 12 years\n* Asthmatic child who, despite treatment with a combination of inhaled corticosteroids (at least 800 mcg / day equivalent Beclomethasone) bronchodilators and long-acting or properly taken daily leukotriene or short acting nebulized bronchodilators (inhaler technique and compliance verified) presents one of the criteria following:\n* Persistence of symptoms or chronic use of bronchodilators short duration of action at least three times a week for at least 3 months\n* exacerbations in the previous year:\n\n * at least one care unit admission or continued resuscitation\n * at least two hospitalizations for acute severe asthma requiring IV therapy\n * at least 2 courses of oral corticosteroids for exacerbations\n* post BD FEV \\<80% or UARS post BD\\> 150% predicted\n* Signature of consent or the holder (s) of parental authority\n* Particular case of patients treated with Xolair® : Patients currently receiving Xolair® but who met the severity criteria of asthma, as described above, before the start of treatment with Xolair® are includable.\n\nChildren with non-severe asthma:\n\nInclusion Criteria\n\n* Child aged 3 to 12 years\n* Controlled without treatment or with low doses of inhaled corticosteroids (\\<500 mg / day beclometasone equivalent) asthma\n* Child with normal EFR (Child over 4 years)\n* Child who did not have more severe exacerbation (assessed taking oral corticosteroids) in the previous year\n* Child not admitted in the previous year for asthma.\n* Signature of consent or the holder (s) of parental authority\n\nExclusion Criteria:\n\n* Child with bronchopulmonary dysplasia\n* Child with severe sequelae of viral infections\n* Refusal of the child or parents Data collection for research and follow up of patients : tests carried out in the 3 months prior to inclusion are used\n\nBlood sample for DNA extraction and the biobank: for young children, sampling at least 4 to 5 ml on dry tubes for serum and 6 ml at least for DNA. These samples should be stored at room temperature, transported within 48 hours to biological resources (CRB) Necker E,fa,ts Malades.'}, 'identificationModule': {'nctId': 'NCT02114034', 'acronym': 'COBRAPed', 'briefTitle': 'Cohort Analysis of Clinical and Biological Severe Childhood Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Cohort Analysis of Clinical and Biological Severe Childhood Asthma', 'orgStudyIdInfo': {'id': 'NI12004'}, 'secondaryIdInfos': [{'id': 'N° ID RCB: 2012-A00539-34'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-severe asthma', 'description': '* Children Controlled without treatment or with low doses of inhaled corticosteroids (\\<500 mg / day beclometasone equivalent) asthma\n* and Children with normal EFR\n* and Children who did not have more severe exacerbation (assessed taking oral corticosteroids) in the previous year\n* and Children not admitted in the previous year for asthma'}, {'label': 'Severe asthma', 'description': 'Asthmatic child who, despite treatment with a combination of inhaled corticosteroids (at least 800 mcg / day equivalent Beclomethasone) bronchodilators and long-acting or properly taken daily leukotriene (inhaler technique and compliance verified) presents one of the 3 criteria following:\n\n* Persistence of symptoms or chronic use of bronchodilators short duration of action at least three times a week for at least 3 months\n* exacerbations in the previous year:\n\n * at least one care unit admission or continued resuscitation\n * at least two hospitalizations for acute severe asthma requiring IV therapy\n * at least 2 courses of oral corticosteroids for exacerbations\n* post BD FEV \\<80% or UARS post BD\\> 150% predicted'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Service de Pneumologie et allergologie pédiatrique, Hôpital Necker-Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Guillaume LEZMI, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique-Hôpitaux Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}