Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-02 @ 10:53 PM
Study NCT ID:
NCT03099902
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
2017-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Secondhand Smoking in Asthmatic Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012135', 'term': 'Respiratory Sounds'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D012119', 'term': 'Respiration'}], 'ancestors': [{'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-10', 'studyFirstSubmitDate': '2017-03-22', 'studyFirstSubmitQcDate': '2017-03-29', 'lastUpdatePostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GSTP1 and TNFa variants in children with asthma', 'timeFrame': '0 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asthma', 'Wheezing', 'GSTP1', 'TNFa', 'Secondhand smoking', 'Passive smoking', 'Intrauterine smoking'], 'conditions': ['Asthma in Children', 'Wheezing']}, 'descriptionModule': {'briefSummary': 'This study will investigate the interaction between GSTP1 / TNFa polymorphisms and passive smoking in children with asthma/wheezing. Contemporary second hand-smoke exposure will be confirmed by laboratory testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects attending the Pediatric Outpatient Clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects 1-18 years old with doctor diagnosed asthma/wheezing\n\nExclusion Criteria:\n\n* Premature birth (\\< 36 gestation weeks)\n* Asthma-like symptoms due to other conditions (infectious, congenital, mechanical)'}, 'identificationModule': {'nctId': 'NCT03099902', 'briefTitle': 'Secondhand Smoking in Asthmatic Children', 'organization': {'class': 'OTHER', 'fullName': 'AHEPA University Hospital'}, 'officialTitle': 'Association Between Maternal Smoking and GSTP1 and TNFa Polymorphism in Children With Asthma/Wheezing', 'orgStudyIdInfo': {'id': '14/1-3-2011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Children with asthma/wheezing whose mothers were active smokers during pregnancy', 'interventionNames': ['Diagnostic Test: Lung function', 'Diagnostic Test: White blood cell DNA extraction', 'Diagnostic Test: Urinary testing']}, {'label': 'Controls', 'description': 'Children without asthma/wheezing whose mothers were active smokers during pregnancy', 'interventionNames': ['Diagnostic Test: Lung function', 'Diagnostic Test: White blood cell DNA extraction', 'Diagnostic Test: Urinary testing']}], 'interventions': [{'name': 'Lung function', 'type': 'DIAGNOSTIC_TEST', 'description': 'Spirometry test', 'armGroupLabels': ['Cases', 'Controls']}, {'name': 'White blood cell DNA extraction', 'type': 'DIAGNOSTIC_TEST', 'description': 'GSTP1 and TNFa polymorphisms with PCR', 'armGroupLabels': ['Cases', 'Controls']}, {'name': 'Urinary testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Urinary nicotine and cotinine detection', 'armGroupLabels': ['Cases', 'Controls']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AHEPA University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSc, Clinical Research Associate', 'investigatorFullName': 'Maria Avgeri', 'investigatorAffiliation': 'AHEPA University Hospital'}}}}