The Role of Macrophage Activation in Lung Injury Following Ozone Exposure
Activated Macrophages and Ozone Toxicity II
2 other identifiers
interventional
120
1 country
1
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. The exposure visits will be at least 2 weeks apart. Subjects will be asked to produce sputum through coughing after each exposure. The samples will be analyzed for macrophage activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
1 active site
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
February 7, 2023
CompletedFirst Submitted
Initial submission to the registry
February 10, 2023
CompletedFirst Posted
Study publicly available on registry
March 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
December 17, 2025
December 1, 2025
4.3 years
February 10, 2023
December 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metabolic activity of inflammatory cells in induced sputum
The metabolic activity of inflammatory cells in sputum will be assessed by the measurement of ATP production. The measurement will be made on an Agilent Seahorse using a Mitoplate Assay.
Within 3 days of exposure
Study Arms (2)
Clean Air, Then Ozone
EXPERIMENTALSubjects will be exposed to clean air for 3 hours at the first exposure visit and 0.2ppm ozone for 3 hours at the second exposure visit. The visits will be at least 2 weeks apart.
Ozone, Then Clean Air
EXPERIMENTALSubjects will be exposed to 0.2 ppm ozone for 3 hours at the first exposure visit and clean air for 3 hours at the second exposure visit. The visits will be at least 2 weeks apart.
Interventions
Eligibility Criteria
You may not qualify if:
- Cardiovascular disease
- Respiratory disease
- Recent (within 4 weeks) respiratory or COVID-19 symptoms
- Diabetes
- Pregnancy
- HIV Infection
- History of smoking within the past 5 years.
- Orthopedic or rheumatologic conditions which would interfere with cycle use
- Inability to produce a sputum plug at screening
- Daily use of antioxidant supplements, excluding those in a multivitamin. These supplements include Vitamin C or E, selenium, beta-carotene, lycopene, lutein, zeaxanthin and ginkgo biloba. Supplements taken less frequently but at least once a week will be reviewed by the principal investigator for eligibility determination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rutgers - EOHSI
Piscataway, New Jersey, 08854, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Howard M Kipen, MD
Rutgers School of Public Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Subjects and laboratory personnel will not be informed of the type of exposure.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 10, 2023
First Posted
March 31, 2023
Study Start
February 7, 2023
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share