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Air Pollution Study: The Effect of Ozone on the Lung

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673775
Recruitment Status : Recruiting
First Posted : February 4, 2016
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
Howard M. Kipen, MD, MPH, Rutgers, The State University of New Jersey

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Air Pollution Other: Clean Air Other: Ozone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Activated Macrophages and Ozone Toxicity
Actual Study Start Date : February 2016
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Air Pollution Ozone

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




Primary Outcome Measures :
  1. Concentrations of M1 and M2 macrophages in the sputum [ Time Frame: Within 3 days of exposure ]
    The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673775


Contacts
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Contact: Kathy Black, PhD 848-445-6049 kgblack@eohsi.rutgers.edu
Contact: Adriana De Resende, BS 848-445-0178 ad998@eohsi.rutgers.edu

Locations
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United States, New Jersey
Environmental and Occupational Health Sciences Institute Recruiting
Piscataway, New Jersey, United States, 08854
Contact: Kathy Black, PhD    848-445-6049    kgblack@eohsi.rutgers.edu   
Contact: Adriana De Resende, BS    848-445-0178    ad998@eohsi.rutgers.edu   
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Principal Investigator: Howard M. Kipen, MD, MPH Rutgers School of Public Health
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Responsible Party: Howard M. Kipen, MD, MPH, Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02673775    
Other Study ID Numbers: Pro20140001089
R01ES004738 ( U.S. NIH Grant/Contract )
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The individual data will be confidential.
Keywords provided by Howard M. Kipen, MD, MPH, Rutgers, The State University of New Jersey:
Macrophage