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| ID | Type | Description | Link |
|---|---|---|---|
| R01ES004738 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clean Air, Then Ozone | Experimental | Subjects 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. |
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| Ozone, Then Clean Air | Experimental | Subjects 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clean Air | Other | Subjects will be exposed to clean air for 3 hours. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Black, PhD | Contact | 8484456049 | kgblack@eohsi.rutgers.edu | |
| Adriana De Resende | Contact | 848-445-0178 | ad998@eohsi.rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Howard M Kipen, MD | Rutgers School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers - EOHSI | Recruiting | Piscataway | New Jersey | 08854 | United States |
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| ID | Term |
|---|---|
| D004780 | Environment, Controlled |
| D010126 | Ozone |
| ID | Term |
|---|---|
| D004777 | Environment |
| D004778 | Environment and Public Health |
| D010100 | Oxygen |
| D005740 | Gases |
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Subjects will be randomly assigned to either clean air or ozone for the first exposure then crossed over to the alternate arm for the second exposure.
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Subjects and laboratory personnel will not be informed of the type of exposure.
| Ozone | Other | Subjects will be exposed to 0.2 ppm ozone for 3 hours. |
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| D007287 |
| Inorganic Chemicals |