NCT00013780

Brief Summary

Ozone is an air pollutant formed in at ground level by the chemical reaction between oxygen and automobile emissions in the presence of sunlight. The objective of this research is to determine how lung size, chemical composition, and normal functioning of the respiratory system affect the amount of inhaled ozone that reaches internal sites of tissue irritation and damage. To infer the distribution of inhaled ozone within the respiratory system, measurements of ozone concentration and air flow are made just outside the nose and mouth of healthy subjects who breathe laboratory-generated, ozonated air for about one hour. Biochemical composition of respiratory mucus is then inferred from nasal washings made with salt water. The amount of ozone that a subject retains in one of these experiments is less than the daily exposure in a large city such as New York or Los Angeles.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 1998

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2001

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
Last Updated

March 23, 2006

Status Verified

March 1, 2006

First QC Date

March 29, 2001

Last Update Submit

March 22, 2006

Conditions

Lung Disease

Keywords

ozone uptakeinhalation toxicologynasal cavitiesantioxidants

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
A subject will be enrolled in the study only if he or she: has not smoked within the past 3 years; and does not have hay fever, asthma, allergic rhinitis, nasal breathing disorders or anatomical abnormalities, chronic respiratory disease, or any other chronic diseases. Women will not be included in the study if they are pregnant. Subjects who regularly take mediation will be excluded from the study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

General Clinical Research Center, Penn State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • James S Ultman, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
NATURAL HISTORY
Time Perspective
OTHER
Sponsor Type
NIH

Study Record Dates

First Submitted

March 29, 2001

First Posted

March 30, 2001

Study Start

July 1, 1998

Study Completion

June 1, 2003

Last Updated

March 23, 2006

Record last verified: 2006-03

Locations

US(1)