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Pulmonary and Inflammatory Responses Following Exposure to a Low Concentration of Ozone or Clean Air

NCT05680831 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-01-11

No results posted yet for this study

Summary

Purpose: 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 undergoing moderate intermittent exercise. This concentration is the current EPA NAAQS standard for ozone.

Conditions

  • Lung Injury, Acute
  • Symptoms and Signs
  • Neutrophilia Acute

Interventions

BIOLOGICAL

0.070 ppm ozone concentration

The concentration of ozone a subject will randomly receive on a visit for 6.6 hours in a controlled atmospheric chamber while performing moderate intermittent exercise.

BIOLOGICAL

Clean air (0.0 ppm ozone)

Same subject will randomly receive clean air on another visit separated by at least one week for 6.6 hours in the same controlled atmospheric chamber while performing moderate intermittent exercise.

Sponsors & Collaborators

  • University of North Carolina

    collaborator OTHER

  • Martin W. Case

    lead FED

Principal Investigators

  • Andy Ghio, M.D. · EPA/ORD/CPHEA/PHITD/CRB

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-13
Primary Completion
2024-02-01
Completion
2025-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05680831 on ClinicalTrials.gov