NCT01639235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
592

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2005

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2012

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

15.9 years

First QC Date

July 9, 2012

Last Update Submit

January 25, 2021

Conditions

Keywords

Secondhand SmokeFlight AttendantsLung functionCardiac functionReproductive health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Clinical Examination

    30 min

  • Characterize the long term effects of prolonged flight time and SHS on reproductive health

    10 minutes

  • Characterize the biomarkers of SHS exposure

    10 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a cross-sectional observational study of flight attendants exposed to secondhand tobacco smoke.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

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.

MeSH Terms

Conditions

Pulmonary Heart Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Rita Redberg, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 12, 2012

Study Start

January 31, 2005

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations