Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-28 @ 12:35 PM
Study NCT ID:
NCT06851403
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-28
First Post:
2024-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness and Safety of Dupilumab in Children with Asthma in China: a Real-world Study
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': 'C582203', 'term': 'dupilumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 213}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2024-10-03', 'studyFirstSubmitQcDate': '2025-02-26', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1', 'timeFrame': 'From enrollment to the end of treatment through study completion, an average of 1 year', 'description': 'forced expiratory volume in one second'}, {'measure': 'FVC', 'timeFrame': 'From enrollment to the end of treatment through study completion, an average of 1 year', 'description': 'forced vital capacity'}, {'measure': 'FEV1/FVC', 'timeFrame': 'From enrollment to the end of treatment through study completion, an average of 1 year', 'description': 'ratio of forced expiratory volume in onesecond to forced vital capacity'}, {'measure': 'PEF', 'timeFrame': 'From enrollment to the end of treatment through study completion, an average of 1 year', 'description': 'peak expiratory flow'}], 'secondaryOutcomes': [{'measure': 'FeNO', 'timeFrame': 'From enrollment to the end of treatment through study completion, an average of 1 year', 'description': 'fraction of exhaled nitric oxide'}, {'measure': 'blood EOS', 'timeFrame': 'From enrollment to the end of treatment through study completion, an average of 1 year', 'description': 'blood eosinophil count'}, {'measure': 'percentage of sputum eosinophils', 'timeFrame': 'From enrollment to the end of treatment through study completion, an average of 1 year'}, {'measure': 'TIgE', 'timeFrame': 'From enrollment to the end of treatment through study completion, an average of 1 year', 'description': 'serum total immunoglobulin E'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['type 2 inflammation', 'asthma', 'dupilumab'], 'conditions': ['Asthma in Children']}, 'descriptionModule': {'briefSummary': 'Observe the changes of type II inflammation markers, lung function, and symptom scores in asthmatic patients aged 6 to 14 during the use of dupilumab to analyze its efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '4 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The attending physician evaluated these patients as having type 2 inflammatory asthma based on factors such as FeNO (fractional exhaled nitric oxide) levels ≥ 20, sputum eosinophils (EOS) percentage ≥ 2%, and/or blood EOS count ≥ 300/μl.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEnrolled patients were required to have been on regular ICS-LABA therapy for at least 3-6 months without adequate control. The attending physician evaluated these patients as having type 2 inflammatory asthma based on factors such as FeNO (fractional exhaled nitric oxide) levels ≥ 20, sputum eosinophils (EOS) percentage ≥ 2%, and/or blood EOS count ≥ 300/μl. All children were prescribed with dupilumab during the study period.\n\nExclusion Criteria:\n\nPatients with conditions other than asthma receiving treatment with dupilumab, individuals currently using other biologics or undergoing sublingual or subcutaneous immunotherapy, active parasitic infections, and children with immunodeficiency were excluded.'}, 'identificationModule': {'nctId': 'NCT06851403', 'briefTitle': 'The Effectiveness and Safety of Dupilumab in Children with Asthma in China: a Real-world Study', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou Institute of Respiratory Disease'}, 'officialTitle': 'The Effectiveness and Safety of Dupilumab in Children with Severe Asthma in China: a Real-world Study', 'orgStudyIdInfo': {'id': 'GuangzhouIRD -LSUN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case group', 'interventionNames': ['Drug: Dupilumab']}], 'interventions': [{'name': 'Dupilumab', 'type': 'DRUG', 'description': 'initial injection of 600 mg, followed by maintenance injections of 300 mg every four weeks', 'armGroupLabels': ['Case group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangzhou institute of respiratory disease', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Institute of Respiratory Disease', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Guangzhou Institute of Respiratory Disease', 'investigatorFullName': 'LI-HONG SUN', 'investigatorAffiliation': 'Guangzhou Institute of Respiratory Disease'}}}}