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 — OTHER
    6.6 hour exposure to 0.07 ppm ozone while at rest
  • Clean air (0.0 ppm ozone) — OTHER
    6.6 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 concentration
    Exposure 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)

FacilityCityStateZIPSite coordinators
EPA Human Studies FacilityChapel HillNorth Carolina27514-

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