The Effect of Low Level Ozone Exposure on Healthy Volunteers

NCT00468221 | Withdrawn Phase 1

• 3 other identifiers: 07-0304R01ES012706R82952201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Ozone; Healthy Adults

Outcome Measures

Primary Outcomes (1)

• Inflammatory markers in sputum

  post exposure

Interventions

Ozone Exposure DRUG

Low dose ozone exposure in chamber

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Adult
• Nonsmoker
• Able to perform light exercise

You may not qualify if:

• Asthma
• active allergies
• chronic disease

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Environmental Protection Agency (EPA): collaborator
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Officials

• Bradford Harris, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 30, 2007
• First Posted: May 2, 2007
• Study Start: June 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 29, 2015

Record last verified: 2015-05