Understanding lung injury from ozone exposure
Activated Macrophages and Ozone Toxicity II
This study is testing how breathing in ozone affects lung injury by looking at immune cell activity in the mucus of people who will exercise after being exposed to both clean air and ozone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 1 site (Piscataway, New Jersey) |
| Trial ID | NCT05794087 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate how ozone exposure affects lung injury by analyzing macrophage activity in sputum samples. Participants will undergo two exposure sessions, one to filtered air and another to 0.2 ppm ozone, with at least two weeks between sessions. Each session will involve physical activity on an exercise bicycle, and follow-up visits will include sputum, blood, and exhaled breath sample collections for analysis. The study is conducted at the Rutgers EOHSI clinical center in Piscataway, NJ.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals who are vaccinated against COVID-19 and can produce sputum samples.
Not a fit: Patients with cardiovascular or respiratory diseases, recent respiratory symptoms, or other specified health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of lung injury mechanisms, potentially informing treatment strategies for those affected by air pollution.
How similar studies have performed: While studies on air pollution and lung injury exist, this specific approach focusing on macrophage activity in response to ozone exposure is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Exclusion Criteria: * Cardiovascular disease * Respiratory disease * Recent (within 4 weeks) respiratory or COVID-19 symptoms * Diabetes * Pregnancy * HIV Infection * History of smoking within the past 5 years. * Orthopedic or rheumatologic conditions which would interfere with cycle use * Inability to produce a sputum plug at screening * Daily use of antioxidant supplements, excluding those in a multivitamin. These supplements include Vitamin C or E, selenium, beta-carotene, lycopene, lutein, zeaxanthin and ginkgo biloba. Supplements taken less frequently but at least once a week will be reviewed by the principal investigator for eligibility determination.
Where this trial is running
Piscataway, New Jersey
- Rutgers - EOHSI — Piscataway, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Howard M Kipen, MD — Rutgers School of Public Health
- Study coordinator: Kathleen Black, PhD
- Email: kgblack@eohsi.rutgers.edu
- Phone: 8484456049
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.