Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT06024902
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2023-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Characteristics of 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 650}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2023-08-30', 'studyFirstSubmitQcDate': '2023-08-30', 'lastUpdatePostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of asthma', 'timeFrame': '12 months', 'description': 'The severity of asthma was comprehensively estimated by a pediatric pulmonologist following the criteria of the Global Initiative for Asthma (GINA) 2021(collecting clinical characteristics, questionnaires and Pulmonary function tests)when patients completed 12-months management.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Severe Asthma']}, 'descriptionModule': {'briefSummary': 'Asthma remains a serious health problem with increasing prevalence and incidence. There is limited information about severe asthma among Chinese pediatric patients. In this context, we decided to explore the clinical characteristics and risk factors of severe asthma in children. This is a descriptive, observational, retrospective cohort study in children with asthma.\n\nThe purpose of this retrospective study is: to determine the clinical characteristics of severe asthma of children; to identify the factors associated with severe childhood asthma.', 'detailedDescription': "Asthma remains a serious health problem with increasing prevalence and incidence. There is limited information about severe asthma among Chinese pediatric patients. In this context, we decided to explore the clinical characteristics and risk factors of severe asthma in children. This is a descriptive, observational, retrospective cohort study in children with asthma.\n\nThe purpose of this retrospective study is: to determine the clinical characteristics of severe asthma of children; to identify the factors associated with severe childhood asthma.\n\nParticipants were consecutively recruited from asthma clinics between January 2021 and December 2021 at Children's Hospital of Fudan University. Patients fulfilling the following criteria were eligible for inclusion: (1) aged 6-17 years old; (2) diagnosed with asthma according to the Global Initiative for Asthma (GINA) 2020 guideline; (3) children and their caregivers are informed and voluntarily join the database and had follow up for at least 1 year. Patients who had cystic fibrosis, mechanical airway obstruction, or any other pulmonary disease or whose parents or legal guardians were not able to fill in the questionnaires were not enrolled.\n\nAt baseline, the asthma specialist questioned each of the patient in the presence of their caregivers to ensure that they supplied accurate disease information and were included according to the criteria. The patients and their caregivers are asked to complete the online questionnaires including the demographic; baseline asthma control, triggers, exacerbation, medication and adherence; environmental exposure, and diagnosis and control of comorbidities, etc. If a patient had poorly controlled comorbidities, multidisciplinary consultation would be recommended. Clinical assessments were arranged at baseline, 3, 6, 9, and 12 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The tertiary specialized children's hospital", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) aged 6-17 years old;\n* (2) diagnosed with asthma according to the Global Initiative for Asthma (GINA) 2020 guideline;\n* (3) children and their caregivers are informed and voluntarily join the database and had follow up for at least 1 year.\n\nExclusion Criteria:\n\n* (1) Patients with cystic fibrosis;\n* (2) had mechanical airway obstruction, or any other pulmonary disease;\n* (3) whose parents or legal guardians were not able to fill in the questionnaires.'}, 'identificationModule': {'nctId': 'NCT06024902', 'briefTitle': 'Clinical Characteristics of Severe Childhood Asthma', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Clinical Characteristics of Severe Childhood Asthma', 'orgStudyIdInfo': {'id': '2023-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'childhood asthma', 'description': 'Subjects with confirmed diagnosis of asthma without other lung disease followed for collection of demographic and clinical data.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '201102', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}