Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-26 @ 7:31 PM
Study NCT ID:
NCT01319292
Status:
COMPLETED
Last Update Posted:
2014-08-04
First Post:
2011-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Investigate the Prevalence of Children Asthma in China
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': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-01', 'studyFirstSubmitDate': '2011-03-17', 'studyFirstSubmitQcDate': '2011-03-18', 'lastUpdatePostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of asthma', 'timeFrame': 'Apr 2013'}], 'secondaryOutcomes': [{'measure': 'prevalence of allergic rhinitis', 'timeFrame': 'Apr 2013'}]}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'Asthma is the most common chronic respiratory disease in children and has much effect on their life and study, which leads to huge economic burden and pressure to the whole families. Some children will develop into adult patients so that asthma can be the life-long vigorous trouble. In recent years, the prevalence rate of children asthma is increasingly going up worldwide. The prevalence rate in last 12 months reported in USA, United Kingdom, Australia, New Zealand was between 12% to 30%.\n\nCenter for Asthma Prevention and Education of Capital Institute of Pediatrics investigated the national asthma prevalence in 900 thousands children in 27 provinces and cities, which average rate was 0.11% to 2.03% in 1990. In 2000, we investigated it again in 31 provinces(43 cities) and the average national children asthma prevalence rate was 1.97%(0.25% to 4.63%) which was much higher than that in 1990.', 'detailedDescription': '1. Objectives\n\n 1. To investigate the national children(0-14 years old)asthma prevalence;\n 2. To compare the prevalence rate between that in 1990 and 2000;\n 3. To analyse the asthma manifestations including the ages, seasons, causes, trigger and hereditary factors and their impact on the asthma patients, families and society;\n 4. To identify the risk factors by questionnaires in case-control research.\n2. Study Design / Clinical Plan\n\n 1. The screening stage: to distinguish suspected asthma from the children age from 0 to 14 years old.\n 2. To obtain identified asthma from the suspected asthma.\n 3. To evaluate the prevalence and severe degree of 0 to 14-year-old children asthma and gain the main risk factors by case-control research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'children age from 0 to 14 years in big cities in China', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children age from 0 to 14 years\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01319292', 'briefTitle': 'To Investigate the Prevalence of Children Asthma in China', 'organization': {'class': 'OTHER', 'fullName': 'Capital Institute of Pediatrics, China'}, 'officialTitle': 'To Investigate the Prevalence of Children Asthma in China and Compare With That of the Last 20 Years', 'orgStudyIdInfo': {'id': 'MISP38877'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Asthma children', 'description': 'children with asthma symptoms through screening'}, {'label': 'normal children', 'description': 'children without symptoms of asthma'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'YuZhi Chen, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Capital Institute of Pediatrics, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Institute of Pediatrics, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chen Yuzhi', 'investigatorAffiliation': 'Capital Institute of Pediatrics, China'}}}}