Effects of Secondhand Smoke on Flight Attendant Health

Cardiopulmonary Disease Clinical Trial

— FAMRI  

Official title:

Cardiopulmonary Effects of Secondhand Smoke Exposure on Flight Attendants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639235
• Other study ID #: 14-13934
• Secondary ID: FAMRI146312
• Status: Completed
• Start date: January 31, 2005
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 592
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary Disease
• Pulmonary Heart Disease

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Flight Attendant Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize the long-term effects of SHS on lung and cardiovascular function in pre-ban flight attendants	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.	25 minutes
Secondary	Clinical Examination	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.	30 min
Secondary	Characterize the long term effects of prolonged flight time and SHS on reproductive health	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.	10 minutes
Secondary	Characterize the biomarkers of SHS exposure	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.	10 minutes