Status:
COMPLETED
Cardiopulmonary Responses to Exposure to Ozone and Diesel Exhaust
Lead Sponsor:
Environmental Protection Agency (EPA)
Conditions:
Respiratory Depression
Blood Pressure
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The US EPA Clean Air Multiyear research program is moving toward a multi-pollutant approach to the assessment of air pollution in response to recommendations by the NRC 2004 and the BOSC in 2005. Such...
Detailed Description
Numerous epidemiological studies have demonstrated an association between acute and chronic exposure to air pollution and various adverse cardiopulmonary effects including mortality, respiratory tract...
Eligibility Criteria
Inclusion
- Healthy men and women between 18 and 55 years of age
- Physical conditioning allowing intermittent, moderate exercise for 2 hours
- Normal lung function:
- FVC \> 75 % of that predicted for gender, ethnicity, age and height.
- FEV1 \> 75 % of that predicted for gender, ethnicity, age and height.
- FEV1/FVC ratio \> 75 % of predicted values.
- Oxygen saturation \> 96 %.
Exclusion
- A history of acute and chronic cardiovascular disease, chronic respiratory disease, diabetes, rheumatologic diseases, immunodeficiency state, and acute respiratory illness within 4 weeks.
- Subjects who are asthmatic or have a history of asthma.
- Allergic to chemical vapors or gases.
- Any allergic symptoms during the time of participation in the study
- Female subjects who are currently pregnant, attempting to become pregnant, or breastfeeding
- Subjects unwilling or unable to stop taking vitamin C or E or medications which may impact the results of the ozone challenge (such as, systemic steroids and beta blockers) at least 2 weeks prior to the study and for the duration of the study. Medications not specifically mentioned here may be reviewed by the investigators prior to a subject's inclusion in the study.
- Current and past smokers within 1 year.
- Uncontrolled hypertension (\> 150 systolic, \> 90 diastolic).
- Subjects who do not understand or speak English
- Subjects unable to perform the moderately active exercise required for the study.
- Subjects with a history of skin allergies to adhesives used in securing heart rate monitor electrodes.
- Unspecified diseases or conditions, which in the judgment of the investigator might influence the responses to the exposures, will be a basis for exclusion.
- Subjects unwilling to stop taking over-the-counter pain medications such as aspirin, Advil, Aleve or other non-steroidal anti-inflammatory medications ("NSAIDS") for 48 hr prior to the exposures and post-exposure visits.
- Subjects with a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds (ms))
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01874834
Start Date
August 1 2010
End Date
January 1 2013
Last Update
June 11 2013
Active Locations (1)
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1
US EPA Human Studies Facility
Chapel Hill, North Carolina, United States, 27514