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The Effect of Low Level Ozone Exposure on Healthy Volunteers

NCT00468221 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-05-29

No results posted yet for this study

Summary

The purpose of this research study is to learn more about the effects of 0.12 ppm ozone exposure on humans. We know from other studies that exposure to levels of ozone that are seen on bad air pollution days, can cause an increased risk of illness and even death in some people with certain health problems like asthma and heart disease. We also know from studies we have done in our lab that even healthy people can have an inflammatory (an increase in the amount of bacteria fighting cells) response to high levels of ozone. We suspect that exposure to low levels of ozone makes the body more susceptible to things like allergens. For instance, in persons allergic to pollen, exposure to ozone in the environment may cause them to have more allergy symptoms when they are around pollen than they would have if they were not exposed to ozone first. In this study we are looking to find the lowest level of ozone to which healthy people can be exposed without seeing that increased immune response. We will use 0.12 ppm ozone; this is roughly the amount of ozone you would be exposed to on a "yellow" ozone day in the triangle area in the summer if you spent the entire day out of doors and exercising moderately.

Conditions

  • Healthy

Interventions

DRUG

Ozone Exposure

Low dose ozone exposure in chamber

Sponsors & Collaborators

  • Environmental Protection Agency (EPA)

    collaborator FED

  • National Institute of Environmental Health Sciences (NIEHS)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Bradford Harris, MD · University of North Carolina

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-11-30
Completion
2009-11-30

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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 NCT00468221 on ClinicalTrials.gov