Cardiopulmonary Responses to Exposure to Ozone and Diesel Exhaust

Completed · Not applicable

Conditions studied: Respiratory Depression, Blood Pressure

In brief

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 an approach better reflects the complexity of real-world air pollution problems and parallels evolving scientific and regulatory considerations. Ozone (O3) and diesel exhaust (DE) generally are major and important components of ambient air pollution. This proposed study will address the agency's goals by investigating the cardiopulmonary health effects in healthy human subjects co-exposed to O3 and DE. The findings derived from these exposures will provide NCEA findings for risk assessments of O3 and DE, as well as the Office of Air and Radiation (includes OTAQ and OAQPS) with information relevant to possible modulation of PM-induced health effects and responses by a gaseous co-pollutant for potential standard setting. Additionally the findings will address the fundamental driving principle of the Clean Air Research strategy related to reduction of health due to air pollutant exposures.

Key facts

Study ID

NCT01874834

Run by

Environmental Protection Agency (EPA)

People needed

15

Starts

2010-08-01

Expected to finish

2013-01-01

Last updated by the study team

2013-06-11

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 %.

You may not qualify if…

• 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))

Where it is running

• US EPA Human Studies Facility — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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