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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. 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. 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clean Air | Placebo Comparator | Subjects will be exposed to clean air for 3 hours. |
|
| Ozone | Experimental | Subjects will be exposed to 0.2 ppm ozone for 3 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clean Air | Other | Subjects will have the clean air exposure first, followed by the ozone exposure |
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| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of M1 and M2 Macrophages in the Sputum 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. | 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. | Relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed. | 72 hours after exposure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Howard M. Kipen, MD, MPH | Rutgers School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Environmental and Occupational Health Sciences Institute | Piscataway | New Jersey | 08854 | United States |
The individual data will be confidential.
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57 were ineligible and 16 were lost to follow-up. 62 were randomized to the first exposure.
135 participants from the local community were screened for eligibility between 2/1/2016 and 5/4/2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ozone Exposure Was First, Followed by Clean Air Exposure | Subjects randomized to ozone first and clean air second. A washout period (at least 2 weeks) took place between exposures. |
| FG001 | Clean Air Exposure Was First, Followed by Ozone Exposure | Subjects randomized to clean air first and ozone second. A washout period (at least 2 weeks) took place between exposures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Exposure |
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| Washout (at Least 2 Weeks) |
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| Second Exposure |
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62 participants were randomized to a first exposure.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All participants who were randomized to a first exposure (N=62) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Concentrations of M1 and M2 Macrophages in the Sputum 24 Hours After Exposure. | The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed. | The number of participants who had an adequate sputum sample collected 24 hours after each exposure. | Posted | Mean | Standard Error | ratio of M2 to M1 macrophages | 24 hours after exposure. |
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Adverse event data were collected until the sputum sample was collected; up to 3 days after the exposure. Induced sputum was collected either 24, 48, or 72 hours after exposure; at the time of sputum collection participants were queried about any effects of the exposure including the need to see medical treatment for breathing difficulties.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clean Air | Participants who received clean air exposure for 3 hours. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Gow, PhD | Rutgers, the State University of New Jersey | 848-445-4612 | gow@pharmacy.rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 9, 2021 | Jun 12, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 7, 2023 | Jul 17, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 26, 2022 | Sep 5, 2025 | ICF_002.pdf |
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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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| Ozone | Other | Subjects will have the ozone exposure first, followed by the clean air exposure |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Concentrations of M1 and M2 Macrophages in the Sputum 48 Hours After Exposure. | The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed. | The number of participants who had an adequate sputum sample collected 48 hours after each exposure. | Posted | Mean | Standard Error | ratio of M2 to M1 macrophages | 48 hours after exposure |
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| Primary | Concentrations of M1 and M2 Macrophages in the Sputum 72 Hours After Exposure. | Relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed. | The number of participants who had an adequate sputum sample collected 72 hours after each exposure. | Posted | Mean | Standard Error | ratio of M2 to M1 macrophages | 72 hours after exposure. |
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| 58 |
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | Ozone | Subjects who were exposed to 0.2 ppm ozone for 3 hours. | 0 | 58 | 0 | 58 | 0 | 58 |
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| D007287 |
| Inorganic Chemicals |