Air Pollution
Conditions
Keywords
Macrophage
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.
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.
Interventions
OTHERClean Air
Subjects will have the clean air exposure first, followed by the ozone exposure
OTHEROzone
Subjects will have the ozone exposure first, followed by the clean air exposure
Sponsors
National Institute of Environmental Health Sciences (NIEHS)
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of M1 and M2 Macrophages in the Sputum 24 Hours After Exposure. | 24 hours after exposure. | The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed. |
| Concentrations of M1 and M2 Macrophages in the Sputum 48 Hours After Exposure. | 48 hours after exposure | The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed. |
| Concentrations of M1 and M2 Macrophages in the Sputum 72 Hours After Exposure. | 72 hours after exposure. | Relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed. |
Countries
United States
Participant flow
Recruitment details
135 participants from the local community were screened for eligibility between 2/1/2016 and 5/4/2022.
Pre-assignment details
57 were ineligible and 16 were lost to follow-up. 62 were randomized to the first exposure.
Participants by arm
| Arm | Count |
|---|---|
| Overall All participants who were randomized to a first exposure (N=62) | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Washout (at Least 2 Weeks) | Lost to Follow-up | 1 | 0 |
| Washout (at Least 2 Weeks) | Physician Decision | 1 | 0 |
| Washout (at Least 2 Weeks) | Study paused during COVID pandemic (3/5/2020 to 9/15/2021) | 2 | 2 |
| Washout (at Least 2 Weeks) | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 23.2 years STANDARD_DEVIATION 4.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 21 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 58 |
| other Total, other adverse events | 0 / 58 | 0 / 58 |
| serious Total, serious adverse events | 0 / 58 | 0 / 58 |
Outcome results
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.
Time frame: 24 hours after exposure.
Population: The number of participants who had an adequate sputum sample collected 24 hours after each exposure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clean Air | Concentrations of M1 and M2 Macrophages in the Sputum 24 Hours After Exposure. | 6.823 ratio of M2 to M1 macrophages | Standard Error 2.413 |
| Ozone | Concentrations of M1 and M2 Macrophages in the Sputum 24 Hours After Exposure. | 1.367 ratio of M2 to M1 macrophages | Standard Error 0.367 |
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.
Time frame: 48 hours after exposure
Population: The number of participants who had an adequate sputum sample collected 48 hours after each exposure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clean Air | Concentrations of M1 and M2 Macrophages in the Sputum 48 Hours After Exposure. | 9.783 ratio of M2 to M1 macrophages | Standard Error 3.239 |
| Ozone | Concentrations of M1 and M2 Macrophages in the Sputum 48 Hours After Exposure. | 3.449 ratio of M2 to M1 macrophages | Standard Error 1.116 |
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.
Time frame: 72 hours after exposure.
Population: The number of participants who had an adequate sputum sample collected 72 hours after each exposure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clean Air | Concentrations of M1 and M2 Macrophages in the Sputum 72 Hours After Exposure. | 4.623 ratio of M2 to M1 macrophages | Standard Error 0.782 |
| Ozone | Concentrations of M1 and M2 Macrophages in the Sputum 72 Hours After Exposure. | 4.379 ratio of M2 to M1 macrophages | Standard Error 0.623 |