N/A
N=62
Air Pollution Study: The Effect of Ozone on the Lung
Air Pollution
Bottom Line
View on ClinicalTrials.gov: NCT02673775 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Concentrations of M1 and M2 Macrophages in the Sputum 24 Hours After Exposure. — 6.823; 1.367 ratio of M2 to M1 macrophages
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Clean Air (Other); Ozone (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentrations of M1 and M2 Macrophages in the Sputum 24 Hours After Exposure. |
6.823; 1.367 | — |
| PRIMARY Concentrations of M1 and M2 Macrophages in the Sputum 48 Hours After Exposure. |
9.783; 3.449 | — |
| PRIMARY Concentrations of M1 and M2 Macrophages in the Sputum 72 Hours After Exposure. |
4.623; 4.379 | — |
Summary
The purpose of the study is to better understand the mechanisms of lung injury from ozone exposure. Subjects will participate in two exposure sessions: filtered air and 0.2 ppm ozone. Subjects will be asked to produce sputum through coughing after each exposure. The samples will be analyzed for macrophage activity.
Eligibility Criteria
Inclusion Criteria
- Healthy men and women
Exclusion Criteria
- Cardiovascular disease
- Respiratory disease
- Diabetes
- Pregnancy
- HIV infection
- History of smoking within the last 5 years
- Daily use of antioxidant supplements (e.g., Vitamin C/E, selenium, beta-carotene, lycopene, lutein, zeaxanthin, or ginkgo biloba)
- Orthopedic or rheumatological conditions that would interfere with cycle use
Data sourced from ClinicalTrials.gov (NCT02673775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.