Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2026-02-01 @ 2:36 PM
Study NCT ID:
NCT02001935
Status:
COMPLETED
Last Update Posted:
2014-08-20
First Post:
2013-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between CytochromeP4501A2 and CytochromeP4502E1 Gene Polymorphisms and Metabolism of Theophylline
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013806', 'term': 'Theophylline'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-19', 'studyFirstSubmitDate': '2013-11-12', 'studyFirstSubmitQcDate': '2013-11-28', 'lastUpdatePostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Theophylline clearance', 'timeFrame': 'Blood samples will be taken after receiving oral thoephylline for 14 days', 'description': "Theophylline and it's metabolite(1,3-dimethyluric) blood concentration"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD', 'theophylline', 'CYP1A2', 'CYP2E1'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine whether common CYP1A2 and CYP2E1 gene polymorphisms effect metabolism of theophylline in chronic obstructive pulmonary disease patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-75 years,COPD patients, male or female;\n* regularly visiting our hospital;\n* taking a sustained-release preparation of theophylline continuously for at least 2 weeks\n\nExclusion Criteria:\n\n* patients with renal or hepatic dysfunction;\n* patients with congestive heart failure;\n* patients with hypothyroidism or hyperthyroidism;\n* patients currently taking drugs likely to affect theophylline metabolism or who had taken such drugs in the preceding week;\n* patients with extreme obesity\n* patients with very severe Chronic Obstructive Pulmonary Disease(COPD)'}, 'identificationModule': {'nctId': 'NCT02001935', 'briefTitle': 'Association Between CytochromeP4501A2 and CytochromeP4502E1 Gene Polymorphisms and Metabolism of Theophylline', 'organization': {'class': 'OTHER', 'fullName': 'Zhujiang Hospital'}, 'officialTitle': 'Association Between CytochromeP4501A2(CYP1A2) and CytochromeP4502E1(CYP2E1) Gene Polymorphisms and Metabolism of Theophylline in a Chinese Population', 'orgStudyIdInfo': {'id': '81302846'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'theophylline', 'interventionNames': ['Drug: theophylline']}], 'interventions': [{'name': 'theophylline', 'type': 'DRUG', 'description': "After oral theophylline 200mg per day for two weeks,bood sample will be collected for determining plasma concentrations of theophylline and it's metabolites and the genotypes of CYP1A2 and CYP2E1", 'armGroupLabels': ['theophylline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510282', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhujiang Hospital,Southern Medical Universtiy', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Wang Liqing, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhujiang Hospital,Southern Medical Unversity'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}