Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-09 @ 8:07 PM
Study NCT ID:
NCT00968305
Status:
COMPLETED
Last Update Posted:
2009-08-28
First Post:
2009-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interleukin (IL)-13 as a Marker in Pediatrics 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_WITHOUT_DNA', 'description': 'Venous blood was obtained to measure total serum immunoglobulin E, radioallergosorbent test for environmental aeroallergens, and for peripheral blood mononuclear cells isolation'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-26', 'studyFirstSubmitDate': '2009-08-19', 'studyFirstSubmitQcDate': '2009-08-26', 'lastUpdatePostDateStruct': {'date': '2009-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin-13 from phytohemagglutinin activated peripheral blood mononuclear cells', 'timeFrame': '7 months (from the start to completion of study. The blood was drawn at the one and only visit for each subject)'}], 'secondaryOutcomes': [{'measure': 'Lung function measured by percent predicted forced expiratory volume in the first second (FEV1%)', 'timeFrame': '7 months (from the start to completion of study, but FEV1% was measured at the one and only visit for each subject)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['African American children with stable asthma', 'Asthma severity', 'Interleukin 13 from PHA stimulated PBMC', 'Lung function (FEV1%)', 'Total serum IgE', 'Pediatrics'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'Asthma is a very common childhood chronic illness and is generally more severe in African Americans. The investigators attempted to determine whether a specific immune marker is associated with lung function and asthma severity.', 'detailedDescription': 'This study examined the relationship between Interleukin (IL)-13 from phytohemagglutinin-activated polymorphonuclear blood cells and asthma severity, lung function (measured as FEV1%), and total serum IgE levels in African American children with clinically diagnosed asthma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'African-American children, ages 8 to 15 years, with clinically diagnosed asthma which had been stable for at least 4 weeks prior to enrollment in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African-American race, born in the U.S.\n* Age 8-15 years\n* Clinical diagnosis of asthma\n* Subject is able to understand and follow verbal instructions in English\n\nExclusion Criteria:\n\n* Asthma exacerbation in the 4 weeks preceding the research visit\n* Oral/IV steroid use in the 4 weeks preceding the research visit\n* Upper or lower respiratory tract infection in the 4 weeks preceding the research visit\n* Antibiotic use in the 4 weeks preceding the research visit\n* Use of a short-acting bronchodilator during the 6 hours prior to spirometry (lung function testing)\n* Use of a long-acting bronchodilator during the 12 hours prior to spirometry (lung function testing)'}, 'identificationModule': {'nctId': 'NCT00968305', 'briefTitle': 'Interleukin (IL)-13 as a Marker in Pediatrics Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Cytokine Production in Children With Asthma.', 'orgStudyIdInfo': {'id': 'L06121901'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with asthma', 'description': 'African American children with clinically diagnosed stable asthma'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center; Clinic: University Consultants in Allergy and Immunology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Byung H Yu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center, Department of Immunology and Microbiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Byung Ho Yu, MD', 'oldOrganization': 'Department of Immunology and Microbiology, Rush University Medical Center'}}}}