Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-01 @ 7:34 PM
Study NCT ID:
NCT00843869
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2009-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reversal of Tobacco-Related Sinusitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096825', 'term': 'Rhinosinusitis'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012852', 'term': 'Sinusitis'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Zinc levels and hair samples will be collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 282}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2009-02-12', 'studyFirstSubmitQcDate': '2009-02-12', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of passive or active smoke exposure', 'timeFrame': 'Completion of study', 'description': 'This study is focused on identifying the prevalence of passive or active smoke exposure and zinc deficiency in a cohort of patients who meet the objective and subjective guidelines for chronic rhinosinusitis set forth by the Sinus and Allergy Health Partnership.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rhinosinusitis']}, 'descriptionModule': {'briefSummary': 'This study is focused on identifying the prevalence of passive or active smoke exposure and zinc deficiency in a cohort of patients who meet the objective and subjective guidelines for chronic rhinosinusitis set forth by the Sinus and Allergy Health Partnership.', 'detailedDescription': 'By using patient screening questionnaires and measuring hair nicotine, a well acknowledged biomarker of exposure to tobacco smoke, we will attempt a more objective study to examine the association between tobacco smoke and chronic rhinosinusitis. (CRS) Likewise, zinc deficiency is documented in numerous animal and human studies to decrease resistance to infectious diseases and is especially common among smokers. We will explore our hypothesis that SHS exposure and zinc deficiency contribute to CRS. To accomplish this, we will measure serum zinc and hair nicotine levels in CRS patients and correlate them to a variety of CRS diagnostic indicators. A second objective of this study is investigating alterations within the epithelium lining the sinonasal cavities in patients with chronic rhinosinusitis. The alterations may be one or a combination of anatomic, genetic, inflammatory, or infectious etiologies. To further investigate these possibilities we plan on taking residual clinical material from endoscopic sinus surgery specimens and performing various in vitro investigations including but not limited to microarray analysis, northern and western blot analysis, ciliary beat frequency analysis, immunohistochemistry, electron microscopy, and propagation of tissue with tissue culture techniques. Tissues taken from non-sinusitis patients undergoing sinonasal surgery will serve as a non-chronic rhinosinusitis control source of sinus mucosa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic rhinosinusitis undergoing routine sinus and skull base surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CRS and skull base surgery patients; CRS patients that meet the objective and subjective guidelines for CRS set forth by the Sinus and Allergy Health Partnership.\n\nExclusion Criteria:\n\n* Ciliary dysfunction, autoimmune disease, CF or any known immunodeficiency.'}, 'identificationModule': {'nctId': 'NCT00843869', 'briefTitle': 'Reversal of Tobacco-Related Sinusitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Reversal of Tobacco-Related Sinusitis (Flight Attendant Medical Research Institute (FAMRI) Young Clinical Scientist Award)', 'orgStudyIdInfo': {'id': 'F080623004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic Rhinosinusitis', 'description': 'Participants with chronic rhinosinusitis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Brad Woodworth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Flight Attendant Medical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Brad Woodworth, MD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}