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Effects of Secondhand Smoke on Flight Attendant Health (FAMRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01639235
Recruitment Status : Recruiting
First Posted : July 12, 2012
Last Update Posted : November 25, 2019
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease
Cardiopulmonary Disease

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Cardiopulmonary Effects of Secondhand Smoke Exposure on Flight Attendants
Study Start Date : January 2005
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Primary Outcome Measures :
  1. Characterize the long-term effects of SHS on lung and cardiovascular function in pre-ban flight attendants [ Time Frame: 25 minutes ]
    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.

Secondary Outcome Measures :
  1. Clinical Examination [ Time Frame: 30 min ]
    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.

  2. Characterize the long term effects of prolonged flight time and SHS on reproductive health [ Time Frame: 10 minutes ]
    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 APeX during the clinic visit are used for analysis on reproductive health of flight attendants.

  3. Characterize the biomarkers of SHS exposure [ Time Frame: 10 minutes ]
    A 45 mL blood specimen is drawn from interested patients to be stored in the research lab as well as analyzed in a 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.

Biospecimen Retention:   Samples With DNA
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This is a cross-sectional observational study of flight attendants exposed to secondhand tobacco smoke.

Inclusion Criteria:

  1. 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.
  2. SHS exposure for at least 1 year while working with the airlines.

Exclusion Criteria:

  1. Less than 1 year of occupational exposure to SHS
  2. Smoking more than 100 cigarettes over a lifetime

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01639235

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Contact: Linnea Rohdin-Bibby 415-412-0872

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United States, California
University of California, San Francisco (UCSF) Recruiting
San Francisco, California, United States, 94143
Contact: Paula Tarr    415-502-2345   
Principal Investigator: Rita Redberg, MD         
Sub-Investigator: Eveline Stock, MD         
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Rita Redberg, MD University of California, San Francisco

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Responsible Party: University of California, San Francisco Identifier: NCT01639235    
Other Study ID Numbers: 14-13934
FAMRI ( Other Grant/Funding Number: FAMRI (Flight Attendant Medical Research Institute) )
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Keywords provided by University of California, San Francisco:
Secondhand Smoke
Flight Attendants
Lung function
Cardiac function
Reproductive health
Additional relevant MeSH terms:
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Pulmonary Heart Disease
Heart Diseases
Cardiovascular Diseases