Cardiopulmonary Study Effects of Secondhand-Smoke (FAMRI)
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First Received Date ICMJE | July 9, 2012 | ||||
Last Updated Date | July 11, 2012 | ||||
Start Date ICMJE | June 2005 | ||||
Estimated Primary Completion Date | January 2017 (final data collection date for primary outcome measure) | ||||
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Change History | Complete list of historical versions of study NCT01639235 on ClinicalTrials.gov Archive Site | ||||
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Cardiopulmonary Study Effects of Secondhand-Smoke | ||||
Official Title ICMJE | A Noninvasive Index of the Detrimental Cardiopulmonary Effects of Environmental Tobacco Smoke | ||||
Brief Summary | The investigators are conducting a study to test whether exposure to secondhand tobacco smoke causes negative effects on the subject's health. In particular, the investigators wish to find out whether secondhand tobacco smoke exposure causes heart or lung problems. |
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Detailed Description | This study aims to ascertain whether standard exercise stress testing can detect subclinical cardiopulmonary disability in subjects with significant exposure to second hand tobacco smoke (SHS). The ultimate goal of this study is to contribute to the understanding of SHS-related illnesses, and to the care of future patients with SHS exposure. 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 against cigarette smoking is responsible for long-term damage to the lungs of nonsmoking flight attendants. Although only some flight attendants show evidence of this damage on their lung function at rest, the majority of the flight attendants will have abnormal diffusing capacity during exercise as the damage may be too subtle to be detected with lung function measurements at rest. To test these hypotheses, we will compare pre- and post-ban flight attendants to each other and to two groups of age-matched, nonsmoking controls living at sea level stratified on the basis of SHS exposure. The results of our study should permit us to determine whether SHS alone could account for the lung damage in flight attendants, or whether some more complex interaction (involving cabin factors such as ozone, altitude, radiation and SHS) may be involve. |
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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Biospecimen | |||||
Sampling Method | Non-Probability Sample | ||||
Study Population | This is a cross-sectional observational study of cases (flight attendants exposed to secondhand tobacco smoke, SHS) and controls (flight attendants not exposed to SHS). |
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Condition ICMJE | Second Hand Smoke | ||||
Intervention ICMJE | |||||
Study Group/Cohort (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 200 | ||||
Estimated Completion Date | June 2017 | ||||
Estimated Primary Completion Date | January 2017 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
The control patients will be age matched flight attendants without aircraft cabin second hand smoke exposure (those who started flying after the tobacco ban). The purpose of having these control groups is to determine if any differences in cardiopulmonary data is due to SHS exposure or other factors associated with flying. In addition, we will recruit non-flight attendants volunteers with and without history of SHS exposure from a previously characterized cohort. These subjects will be age-matched control group of never smokers, and must have grown up and spent the majority of their adulthood at sea level and have had no connection with the airline industry. Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01639235 | ||||
Other Study ID Numbers ICMJE | 10-04549, FAMRI | ||||
Has Data Monitoring Committee | |||||
Responsible Party | University of California, San Francisco | ||||
Study Sponsor ICMJE | University of California, San Francisco | ||||
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Investigators ICMJE |
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Information Provided By | University of California, San Francisco | ||||
Verification Date | July 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |