Air Pollution Study: The Effect of Ozone on the Lung

September 18, 2023 updated by: Howard M. Kipen, MD, MPH, Rutgers, The State University of New Jersey

Activated Macrophages and Ozone Toxicity

The purpose of the study is to better understand the mechanisms of lung injury from ozone exposure. Subjects will participate in two exposure sessions: filtered air and 0.2 ppm ozone. Subjects will be asked to produce sputum through coughing after each exposure. The samples will be analyzed for macrophage activity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will be asked to come to the Rutgers EOHSI clinical center (Piscataway, NJ) for 5 study visits. A physical exam to determine eligibility will be done at the first study visit. If the subject is healthy and able to produce a sputum sample, he/she will then be scheduled for 2 3-hour exposure visits. One exposure will be to clean air and the other exposure will be to 0.2 ppm ozone. During the exposures, subjects will be requested to ride an exercise bicycle intermittently (approximately every 15 minutes). A follow-up visit for sputum collection will be scheduled either 24, 48, or 72 hours after each exposure visit. Blood, urine, and exhaled breath samples will also be collected at each visit.

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Environmental and Occupational Health Sciences Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy men and women

Exclusion Criteria:

  • Cardiovascular disease
  • Respiratory disease
  • Diabetes
  • Pregnancy
  • HIV infection
  • History of smoking within the last 5 years
  • Daily use of antioxidant supplements (e.g., Vitamin C/E, selenium, beta-carotene, lycopene, lutein, zeaxanthin, or ginkgo biloba)
  • Orthopedic or rheumatological conditions that would interfere with cycle use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Clean Air
Subjects will be exposed to clean air for 3 hours.
Other: Clean Air
Subjects will have the clean air exposure first, followed by the ozone exposure
Experimental: Ozone
Subjects will be exposed to 0.2 ppm ozone for 3 hours.
Other: Ozone
Subjects will have the ozone exposure first, followed by the clean air exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentrations of M1 and M2 Macrophages in the Sputum 24 Hours After Exposure.
Time Frame: 24 hours after exposure.
The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.
24 hours after exposure.
Concentrations of M1 and M2 Macrophages in the Sputum 48 Hours After Exposure.
Time Frame: 48 hours after exposure
The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.
48 hours after exposure
Concentrations of M1 and M2 Macrophages in the Sputum 72 Hours After Exposure.
Time Frame: 72 hours after exposure.
Relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.
72 hours after exposure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Institute of Environmental Health Sciences (NIEHS)

Investigators

  • Principal Investigator: Howard M. Kipen, MD, MPH, Rutgers School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

June 7, 2022

Study Completion (Actual)

June 7, 2022

Study Registration Dates

First Submitted

January 29, 2016

First Submitted That Met QC Criteria

February 1, 2016

First Posted (Estimated)

February 4, 2016

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro20140001089
  • R01ES004738 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual data will be confidential.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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