Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-31 @ 7:55 AM
Study NCT ID:
NCT01639235
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2012-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Secondhand Smoke on Flight Attendant Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011660', 'term': 'Pulmonary Heart Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'There is an optional blood draw blood portion to the research study. A sample is collected from the interested flight attendant. The majority of the sample is processed and stored in the FAMRI biorepository for future research purposes to identify biomarkers of cardiovascular risk and secondhand smoke. The remainder of the sample is analyzed for the flight attendant. A lipid profile is sent to the flight attendant participant.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 592}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2012-07-09', 'studyFirstSubmitQcDate': '2012-07-11', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterize the long-term effects of SHS on lung and cardiovascular function in pre-ban flight attendants', 'timeFrame': '25 minutes', 'description': 'A spirometry test is performed by the Clinical Research Coordinator to establish the lung function of the flight attendant participant and medical assistants from the cardiovascular care clinic administer a 12-lead non-invasive electrocardiogram.'}], 'secondaryOutcomes': [{'measure': 'Clinical Examination', 'timeFrame': '30 min', 'description': "The cardiologist performs a noninvasive assessment of the patient's vascular function, which includes a brief physical examination, blood pressure measurement, pulse, and oxygen level."}, {'measure': 'Characterize the long term effects of prolonged flight time and SHS on reproductive health', 'timeFrame': '10 minutes', 'description': 'Flight attendants fill out the electronic Exposure Questionnaire prior to their appointments. Part of the Questionnaire is a section on reproductive health. The answers to these survey questions in addition to information gathered and saved in the local medical record system (APeX) during the clinic visit are used for analysis on reproductive health of flight attendants.'}, {'measure': 'Characterize the biomarkers of SHS exposure', 'timeFrame': '10 minutes', 'description': 'A 45 mL blood specimen is drawn from interested patients to be stored in the research lab as well as analyzed in a University of California, San Francisco (UCSF) laboratory. Results of the blood analysis performed in the research labs, such as secondhand smoke biomarkers and advanced lipid biomarkers, will not be shared with the subject.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Secondhand Smoke', 'Flight Attendants', 'Lung function', 'Cardiac function', 'Reproductive health'], 'conditions': ['Cardiopulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This is a study on a population of flight attendants who were exposed to occupational secondhand tobacco smoke (SHS). This research will examine associations between flight attendant SHS exposure and development of respiratory illnesses, reproductive problems, and cardiovascular diseases.', 'detailedDescription': 'The main hypothesis of this study is that exposure to the secondhand tobacco smoke (SHS) in the confined workspace of commercial aircraft prior to the ban of cigarette smoking is responsible for long-term damage on the health of nonsmoking flight attendants. We will compare the data collected from our pre-ban flight attendant participants to age-matched, nonsmoking controls from the NHANES (National Health and Nutrition Examination Survey) database. The results of our study should permit us to determine if SHS exposure is the cause of long-term increased cardiovascular morbidity and risk, as well as increased susceptibility to respiratory illnesses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a cross-sectional observational study of flight attendants exposed to secondhand tobacco smoke.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Never smoker flight attendants who began working for airlines before the smoking ban on aircrafts went into effect. Never smoker is defined as those with history of tobacco use of less than 100 cigarettes in their lifetime.\n2. SHS exposure for at least 1 year while working with the airlines.\n\nExclusion Criteria:\n\n1. Less than 1 year of occupational exposure to SHS\n2. Smoking more than 100 cigarettes over a lifetime'}, 'identificationModule': {'nctId': 'NCT01639235', 'acronym': 'FAMRI', 'briefTitle': 'Effects of Secondhand Smoke on Flight Attendant Health', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Cardiopulmonary Effects of Secondhand Smoke Exposure on Flight Attendants', 'orgStudyIdInfo': {'id': '14-13934'}, 'secondaryIdInfos': [{'id': 'FAMRI', 'type': 'OTHER_GRANT', 'domain': 'FAMRI (Flight Attendant Medical Research Institute)'}, {'id': '146312', 'type': 'OTHER', 'domain': 'University of California, San Francisco'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Rita Redberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Flight Attendant Medical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}