The Effect of Low Level Ozone Exposure on Healthy Volunteers (Lowoz)

This study has been terminated.
(Lack of funding)
Sponsor:
Collaborator:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00468221
First received: April 30, 2007
Last updated: April 28, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Ozone Exposure
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effect of Low Level Ozone Exposure on Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Inflammatory markers in sputum [ Time Frame: post exposure ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ozone Exposure
    Low dose ozone exposure in chamber
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Adult
  • Nonsmoker
  • Able to perform light exercise

Exclusion Criteria:

  • Asthma
  • active allergies
  • chronic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468221

Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Bradford Harris, MD University of North Carolina
  More Information

No publications provided

Responsible Party: Bradford Harris, MD, UNC_Chapel Hill
ClinicalTrials.gov Identifier: NCT00468221     History of Changes
Other Study ID Numbers: 07-0304, RO-1 ES012706, R82952201
Study First Received: April 30, 2007
Last Updated: April 28, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Ozone
Healthy Adults

ClinicalTrials.gov processed this record on July 29, 2014