Pulmonary and Inflammatory Responses Following Exposure to a Low Concentration of Ozone or Clean Air at Rest
Part of paid clinical trials in Chapel Hill, North Carolina.
- Sponsor
- Environmental Protection Agency (EPA)
- Study ID
- NCT06943989
- Status
- Enrolling By Invitation
Conditions
- Experimental Lung Inflammation
- Lung Inflammation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 35 Years
- Healthy Volunteers
- Accepted
Interventions
- Ozone Exposure — OTHER6.6 hour exposure to 0.07 ppm ozone while at rest
- Clean air (0.0 ppm ozone) — OTHER6.6 hour exposure to clean air (0.00 ppm ozone) while at rest
Study Details
The primary purpose of this study is to measure pulmonary function, symptoms, and pulmonary inflammatory responses in healthy young adults during and immediately after exposure to a low concentration of ozone (0.070 ppm) or clean air for 6.6 hours while at rest. This concentration is the current EPA NAAQS standard for ozone.
Key Dates
- Start date
- Nov 5, 2024
- Status verified
- Apr 2025
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: 0.070 ppm ozone concentrationExposure to 0.070 ppm ozone for 6.6 hours at rest
- Experimental: Clean air (0.0 ppm ozone)Exposure to clean air (0.0 ppm ozone) for 6.6 hours while at rest
Primary Outcome Measure
FVC [ Time Frame: measured (pre) before starting 6.6 hours of exposure, , immediately after (post), and at follow up 24 hours later (Follow Up) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| EPA Human Studies Facility | Chapel Hill | North Carolina | 27514 | - |
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