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Purpose: To determine whether 3-day consecutive exposures to levels of fine particulate matter (PM2.5) that are close to the current 24-hr national standard will cause changes in inflammatory and cardiopulmonary endpoints in healthy young individuals.
Participants: 20 healthy males and females aged 18-35 years.
Procedures (methods): Subjects will be randomly exposed to three consecutive days of filtered air (4 hr/day) and three consecutive days of PM2.5 (approximately 35 µg/m3; 4 hr/day) in an exposure chamber. Blood collection for inflammatory factors such as C-reactive protein (CRP), clotting factors; heart rate variability (HRV); spirometry; and a symptom questionnaire will be conducted before and after each exposure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filtered air exposure | Experimental | Subjects will be randomly exposed to three consecutive days of filtered air exposure arm in a double-blind cross-over fashion in an exposure chamber, and exposures will be separated by a minimum of 13 days from the PM2.5 arm. |
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| PM exposure | Experimental | Subjects will be randomly exposed to three consecutive days of PM2.5 exposure arm in a double-blind cross-over fashion in an exposure chamber, and exposures will be separated by a minimum of 13 days from the filtered air arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PM exposure | Other | To determine whether 3-day consecutive exposures to levels of fine particulate matter (PM2.5) that are close to the current 24-hr national standard will cause changes in inflammatory and cardiopulmonary endpoints. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood inflammation marker, CRP, will be measured 2 hours before each air exposure day and follow up day in 20 subjects | Venous blood will be collected for CRP measurement 2 hours before each air exposure day on day 1, day 2, day 3, and follow up day in 20 subjects. | Four days |
| Blood inflammation marker, CRP, will be measured 2 hours before each PM exposure day and follow up day in 20 subjects | Venous blood will be collected for CRP measurement 2 hours before each PM exposure day on day 1, day 2, day 3 and follow up day in 20 subjects. | Four days |
| Blood inflammation marker, CRP, will be measured 1 hour after each air exposure day in 20 subjects | Venous blood will be collected for CRP measurement 1 hour after each air exposure day on day 1, day 2, and day 3 in 20 subjects. | Three days |
| Blood inflammation marker, CRP, will be measured 1 hour after each PM exposure day in 20 subjects | Venous blood will be collected for CRP measurement 1 hour after each PM exposure day on day 1, day 2, and day 3 in 20 subjects. | Three days |
| Measure | Description | Time Frame |
|---|---|---|
| Spirometry will be measured 1 hour before each air exposure day and follow up day in 20 subjects | FEV1 and FVC will be measured by spirometry 1 hour before each air exposure day on day 1, day 2, day 3, and follow up day in 20 subjects. | Four days |
| Spirometry will be measured 1 hour before each PM exposure day and follow up day in 20 subjects |
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Inclusion Criteria:
. Age 18-35 years old healthy male and female (BMI values between 19 and 30).
. Physical conditioning allowing intermittent, moderate exercise for 2 hours, and ability to complete the exposure exercise regimen to induce a minute ventilation rate of 20 L/min/m2 for 15 min without exceeding 80% of projected maximal heart rate. Predicted maximal heart rate will be calculated using the equation [described by Tanaka et al.: (2001) J. Am. Coll. Cardiol: 208bpm-((0.7) x (age in years))]
. Normal baseline 12-lead EKG.
. Normal lung function based on NHANES III reference values. i. Forced vital capacity (FVC) ≥ 80% of that predicted for age, gender, ethnicity, and height.
ii. Forced expiratory volume in one second (FEV1) ≥ 80% of that predicted for age, gender, ethnicity, and height.
iii: FEV1/FVC ratio ≥ 80% of predicted values.
. Oxygen saturation greater than 94% at the time of physical exam.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrice Ratliffe | Contact | 919-966-0607 | Ratliffe.Patrice@epa.gov |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EPA Human Studies Facility | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
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| Filtered air exposure | Other | To determine whether 3-day consecutive exposures to filtered air will cause changes in inflammatory and cardiopulmonary endpoints. |
|
FEV1 and FVC will be measured by spirometry 1 hour before each PM exposure day on day 1, day 2, day 3 and follow up day in 20 subjects. |
| Four days |
| Ambulatory ECG will be measured 2 hours before each air exposure day and follow up day in 20 subjects | ECG QT interval and frequency power of ECG will be measured by Holter monitor for 5 minutes at 2 hour before each air exposure day on day 1, day 2, day 3, and follow up day in 20 subjects. | Four days |
| Ambulatory ECG will be measured 2 hours before each PM exposure day and follow up day in 20 subjects | ECG QT interval and frequency power of ECG will be measured by Holter monitor for 5 minutes at 2 hours before each PM exposure day on day 1, day 2, day 3, and follow up day in 20 subjects. | Four days |
| Spirometry will be measured 1 hour after each air exposure day in 20 subjects | FEV1 and FVC will be measured by spirometry 1 hour after each air exposure day on day 1, day 2, and day 3 in 20 subjects. | Three days |
| Spirometry will be measured 1 hour after each PM exposure day in 20 subjects | FEV1 and FVC will be measured by spirometry 1 hour after each PM exposure day on day 1, day 2, and day 3 in 20 subjects. | Three days |
| Ambulatory ECG will be measured 2 hours after each air exposure day in 20 subjects | ECG QT interval and frequency power of ECG will be measured by Holter monitor for 5 minutes at 2 hours after each air exposure day on day 1, day 2, and day 3 in 20 subjects. | Three days |
| Ambulatory ECG will be measured 2 hours after each PM exposure day in 20 subjects | ECG QT interval and frequency power of ECG will be measured by Holter monitor for 5 minutes at 2 hours after each PM exposure day on day 1, day 2, and day 3 in 20 subjects. | Three days |