NCT02797275Active, not recruitingPhase 4
Secondhand Smoke Respiratory Health Study
Lung Anatomic, Physiologic, and Inflammatory Changes With Chronic Exposure to Secondhand Tobacco Smoke
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 107 (actual)
- First submitted
- 6 May 2016
- Start date
- 6 Jun 2016
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of California, San Francisco
- NCT number
- NCT02797275
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 107
- From 6 Jun 2016 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
- 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
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Medical Center Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.