Trial record 7 of 28 for:    "secondhand smoke" | Open Studies

Effects of Secondhand Smoke on Flight Attendant Health (FAMRI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01639235
First received: July 9, 2012
Last updated: May 26, 2015
Last verified: May 2015
  Purpose

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
Cardiopulmonary Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Cardiopulmonary Effects of Secondhand Smoke Exposure on Flight Attendants

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Characterize the long-term effects of SHS on lung and cardiovascular function in pre-ban flight attendants [ Time Frame: 25 minutes ] [ Designated as safety issue: No ]
    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:
  • Clinical Examination [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    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.

  • Characterize the long term effects of prolonged flight time and SHS on reproductive health [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    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.

  • Characterize the biomarkers of SHS exposure [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]
    A 45 mL blood specimen is drawn from interested patients to be stored in the research lab as well as analyzed in the CLIA approved 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. Results of the standard lipid panel (analyzed in a CLIA approved laboratory) will 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.


Estimated Enrollment: 2000
Study Start Date: January 2005
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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 cigerettes over a lifetime
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639235

Contacts
Contact: Victoria Hayes 415-412-0872 Victoria.Hayes@ucsf.edu
Contact: Paula Tarr 415-502-2345 Paula.Tarr@ucsf.edu

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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01639235     History of Changes
Other Study ID Numbers: 14-13934, FAMRI
Study First Received: July 9, 2012
Last Updated: May 26, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Secondhand Smoke
Flight Attendants
Lung function
Cardiac function
Reproductive health

Additional relevant MeSH terms:
Pulmonary Heart Disease
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on July 01, 2015