Interaction Effects of Temperature and Ozone

Completed · Not applicable

Conditions studied: Exposure to Environmental Pollution, Non-occupational

In brief

Purpose: The purpose of this protocol is to understand how individuals respond to the air pollutant ozone at elevated temperatures. Ultimately, this will help us understand what the risks from poor air quality are during a heat wave. Participants: We will recruit up to 30 healthy adults, 18-55 years old, to participate in this study. Procedures (methods): Subjects will be exposed to clean air and to 0.3 ppm of ozone for 2 hours with intermittent exercise in a controlled environment chamber. For each exposure the temperature in the chamber will be between 31-34oC (88-93 oF). Because the aim of the study is to mimic high exposure during a heat wave, we will perform exposures only on days when mean ambient temperatures was less than 24 oC in Chapel Hill on the previous day. Primary endpoints will include spirometry and Heart Rate Variability monitoring. Secondary endpoints will include analysis of blood clotting/coagulation factors, and analysis of soluble factors present in plasma.

Key facts

Study ID

NCT01981135

Run by

Environmental Protection Agency (EPA)

People needed

16

Starts

2011-09-01

Expected to finish

2015-01-01

Last updated by the study team

2015-02-10

Who can join

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

You may qualify if…

• 1. Pass a physical exam performed by study physicians during the screening visit under a separate protocol.
• 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. 3. Oxygen saturation of > 96 %. 4. Ability to tolerate intervals of moderate exercise.

You may not qualify if…

• 1. A history of chronic illnesses such as diabetes, rheumatological diseases, immunodeficiency state, known clinically significant cardiac disease (including myocardial infarction, congestive heart failure and angina), chronic respiratory diseases such as chronic obstructive pulmonary disease, asthma and lung cancer.
• If the subject is pregnant, attempting to become pregnant or breastfeeding. 3. Subjects currently taking medications which may impact the results of the ozone challenge or interfere with any other medications potentially used in the study (to include systemic steroids and beta blockers). Subjects must refrain from all over the counter anti-inflammatory agents, and anti-oxidants for a period of one week prior to exposure. Medications not specifically mentioned here may be reviewed by the investigators prior to a subject's inclusion in the study.
• Smoking history within 2 years of the study. 5. Untreated hypertension (≥ 150 systolic, ≥ 90 diastolic). 6. Skin diseases or sensitivity precluding the use of ECG electrodes. 7. Symptom score greater than 21 (out of a possible 40-see accompanying score sheet) for total symptom score. Only one score may be equal to 3.
• Dementia. 9. Unspecified illness or condition which in the judgment of the investigator might increase the risk associated with inhalation challenge or exercise.
• Subjects who do not understand or speak English. 11. Subjects who are unable to perform moderate exercise.

Where it is running

• U.S. EPA Human Studies Facility — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.