The Role of Macrophage Activation in Lung Injury Following Ozone Exposure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clean Air, Ozone.
- Who it may be relevant to
- Registry conditions: Air Pollution. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Activated Macrophages and Ozone Toxicity II
Overview
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.
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, at least 2 weeks apart. 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 and exhaled breath samples will also be collected at each visit.
Interventions
- Other Clean Air
Subjects will be exposed to clean air for 3 hours. - Other Ozone
Subjects will be exposed to 0.2 ppm ozone for 3 hours.
Primary outcome measures
- Metabolic activity of inflammatory cells in induced sputum [Time frame: Within 3 days of exposure]
Eligibility criteria
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Rutgers - EOHSI — Piscataway
Identifiers
NCT: NCT05794087 · Pro2022002024 · R01ES004738