Effects of Sequential Exposure to Nitrogen Dioxide and Ozone in Healthy Adult Human Volunteers.

Completed · Not applicable

Conditions studied: Respiratory Depression

In brief

The U.S. Environmental Protection Agency has traditionally examined the effects of single pollutant exposure on human health outcomes; however, to provide a better assessment of pollutant exposure-associated effect on human health the Agency is moving toward a multi-pollutant approach. Ozone (O3) and nitrogen dioxide (NO2) are national ambient air quality standards (NAAQS) criteria pollutants that are major constituents of ambient air pollution. This study will address the Agency's goals by investigating the cardiopulmonary health effects of sequential exposure to O3 and NO2 in healthy adult human volunteers. The findings of this study will provide data that will inform risk assessment models for O3 and NO2 exposures. Additionally, the findings will provide insight into how the human health effects of multi-pollutant exposures differ from those of single pollutant exposures.

Key facts

Study ID

NCT02133586

Run by

Environmental Protection Agency (EPA)

People needed

54

Starts

2014-01-01

Expected to finish

2016-01-01

Last updated by the study team

2020-08-17

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy men and women between 18 and 40 years of age.
• Physical conditioning allowing intermittent, moderate exercise for two hours.
• Ability to complete the exposure exercise regimen without reaching 80% of predicted maximal heart rate.
• Normal baseline 12-lead baseline EKG or if not normal the EKG must be approved by a study cardiologist.
• Normal lung function
• Forced vital capacity (FVC) >75% of that predicted for gender, ethnicity, age, and height (according to National Health and Nutrition Examination Survey [NHANESIII] guidelines).
• Forced expiratory volume in one second (FEV1) > 75% of that predicted for gender, ethnicity, age, and height (according to NHANESIII guidelines).
• FEV1/FVC ration >75% of predicted values (according to NHANESIII guidelines).
• Oxygen saturation >96% on room air.

You may not qualify if…

• Individuals with a history of acute or chronic cardiovascular disease, chronic respiratory disease, diabetes, rheumatologic disease, or immunodeficiency state.
• Individuals with a Framingham risk score (Hard Coronary Heard Disease [HCHD] 10-year risk) ≥10.
• Individuals with asthma or a history of asthma.
• Individuals who are allergic to chemical vapors or gases.
• Females who are pregnant, attempting to become pregnant, or breastfeeding.
• Individuals that are unwilling or unable to stop taking vitamin C or E, or medications that may impact the results of ozone challenge such at least two 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 an individual's inclusion in the study.
• Individuals who have smoked tobacco during the last five years or those with a history of >5 pack years.
• Individuals living with a smoker who smokes inside the house.
• Individuals with a body mass index (BMI) >30 or <18. Body mass index is calculated by dividing the weight in kilograms by the square of the height in meters.
• Individuals with occupational exposures to high levels of vapors, dust, gases, or fumes on an on-going basis.
• Individuals with uncontrolled hypertension (≥150 systolic or ≥90 diastolic).
• Individuals that do not understand or speak English.
• Individuals that are unable to perform the exercise required for the study.
• Individuals that are taking beta blocker medications.
• Individuals with a history of skin allergies to adhesives used in securing EKG electrodes.
• Individuals with unspecified diseases, conditions, or medications that might influence the responses to the exposures, as judged by the medical staff.
• Individuals that are unwilling or unable to stop taking over-the-counter pain medications such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), or other non-steroidal anti-inflammatory ("NSAID") medications for 48 hours prior to the exposures and post-exposure visits.
• Individuals that are taking systemic steroids or beta-blocker medications.
• Individuals with a hemoglobin A1c (HbA1c) level > 6.4%.
• Temporary Exclusion Criteria
• Individuals with active seasonal allergies during the time of participation in the study.
• Individuals suffering from acute respiratory illness within four weeks prior to any of the study exposure series.
• Individuals that have been exposed to smoke and fumes within 24 hours of any study visit.
• Individuals that have consumed alcohol within 24 hours of any study visit.
• Individuals that have engaged in strenuous exercise within 24 hours of any study visit.

Where it is running

• E.P.A. Human Studies Facility — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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