Interaction Effects of Temperature and Ozone

NCT01981135 | Completed

• 1 other identifier: #11-0772
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Exposure to Environmental Pollution, Non-occupational

Keywords

Controlled Human exposure study; Air Pollution; Temperature; Lung Function; Cardiovascular

Outcome Measures

Primary Outcomes (1)

• Forced expired volume in the first second (FEV1)

  Forced expired volume in the first second (FEV1) is determined by spirometry performed on a dry seal spirometer interfaced to a computer.

  Pre exposure to 24hours post exposure

Secondary Outcomes (4)

• Index of clotting/coagulation factor

  Pre exposure to 24hours post exposure

• Index of inflammatory markers

  Pre exposure to 24hours post exposure

• Forced Vital Capacity

  Pre exposure to 24hours post exposure

• Changes in heart rate variability

  Pre exposure to 24hours post exposure

Study Arms (2)

Clean Air

SHAM COMPARATOR

Exposure to clean air will be conducted in an exposure chamber at the EPA Human Studies Facility on the UNC campus.

Other: Clean Air

Ozone

EXPERIMENTAL

Exposure to ozone will be conducted in an exposure chamber at the EPA Human Studies Facility on the UNC campus.

Other: Ozone

Interventions

Clean Air OTHER

Each subject will be exposed to clean air for 2 hours. The exposure atmosphere will be at a temperature between 31-34oC (88-93 oF) and approximately 40 + 10% RH. Subjects will exercise on a bike. Each exercise session will consist of a 15 minute exercise interval at a level of up to 25 L/min/m2BSA followed by a 15 minute rest period.

Clean Air

Ozone OTHER

Each subject will be exposed up to 0.3ppm ozone for 2 hours. The exposure atmosphere will be at a temperature between 31-34oC (88-93 oF) and approximately 40 + 10% RH. Subjects will exercise on a bike. Each exercise session will consist of a 15 minute exercise interval at a level of up to 25 L/min/m2BSA followed by a 15 minute rest period.

Also known as: O3

Ozone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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:

• \. 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.
• \. 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.

Sponsors & Collaborators

• Environmental Protection Agency (EPA): lead

Study Sites (1)

U.S. EPA Human Studies Facility

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Interventions

Environment, Controlled; Ozone

Intervention Hierarchy (Ancestors)

Environment; Environment and Public Health; Oxygen; Gases; Inorganic Chemicals

Study Officials

• David Diaz-Sanchez, PhD

  U.S. Environmental Protection Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Clinical Research Branch

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: November 11, 2013
• Study Start: September 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

US (1)