Secondhand Smoke Respiratory Health Study

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Exposure to secondhand tobacco smoke (SHS) is associated with diverse health effects in nonsmokers. Flight attendants (FA) who worked on commercial aircraft before the ban on tobacco smoking (exposed FAs) had high, long-term levels of occupational exposure to SHS and are a unique population for the study of long-term health effects of chronic exposure to SHS.

In previous studies, we have shown that many never-smoking SHS-exposed FAs to have curvilinear flow-volume loops, decreased airflow at mid- and low-lung volumes, and static air trapping (elevated residual volume to total lung capacity ratio [RV/TLC]), abnormalities that are not diagnostic of overt Chronic Obstructive Pulmonary Disease (COPD), but do implicate the presence of an obstructive ventilatory defect, and are consistent with what has been recently described as preserved ratio impaired spirometry (PRISm).

The main objective of the study is to determine the effect of a bronchodilator to counter the physiologic abnormalities that are observed in the population of never-smoking SHS-exposed FAs as both proof of concept of the presence of an obstructive lung disease and as a possible therapeutic option to counteract the adverse respiratory effects of chronic exposure to SHS.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Flight Attendant Medical Research Institute
• Treatments: Albuterol

Criteria

Inclusion Criteria:

1. Never Smoking SHS-exposed Flight Attendants:

• aircraft cabin SHS exposure of >1 year while working for airlines

• Never smoker as defined by use of <100 cigarettes lifetime and none within the last year.

• Normal forced expiratory volume (FEV) FEV1/ forced vital capacity (FVC) ratio

• One of the following evidence of airflow obstruction:

• Presence of any airflow limitation on spirometry during the baseline visit

• Development of airflow limitation on spirometry during any stages of exercise testing

• Residual volume to total lung capacity ratio of >0.35

2. Exclusion Criteria:

• History of active cardiac disease, uncontrolled hypertension, congestive heart failure

• History of direct tobacco use of over 100 cigarettes in their lifetime

• History of established respiratory diseases such as asthma, emphysema, chronic bronchitis, interstitial lung disease, or sarcoidosis

• History of debilitating chronic illnesses such as severe lupus or rheumatoid arthritis

• History of other illnesses or therapy for illnesses that could affect lung function such as radiation therapy for breast cancer

• Physical inability to perform exercise testing

• BMI >30 kg/m2

• History of marijuana use of >100 joints lifetime, and none within the last year

• History of other recreational drug use