Recruiting
Phase 1

Ozone

Sponsor:

Martin W. Case

Code:

NCT05680831

Conditions

Lung Injury, Acute

Symptoms and Signs

Neutrophilia Acute

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

0.070 ppm ozone concentration

Clean air (0.0 ppm ozone)

Study Details

Brief summary:

Purpose: The primary purpose of this study is to measure pulmonary function, symptoms, and pulmonary inflammatory responses in healthy young adults during and immediately after exposure to a low concentration of ozone (0.070 ppm) or clean air for 6.6 hours while undergoing moderate intermittent exercise. This concentration is the current EPA NAAQS standard for ozone.

Conditions

Lung Injury, Acute

Symptoms and Signs

Neutrophilia Acute

Study ID

NCT05680831

Start date

Oct 13, 2022

Status verified date

Jan, 2023

Completion date

Feb 1, 2025

Anticipated

Primary completion date

Feb 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Healthy men and women between 18 and 35 years of age.
2. Physical conditions allowing sustained moderate exercise for 6.6 hours.
3. Normal lung function (NHANES III):

1. FVC > 80 % of that predicted for gender, ethnicity, age and height.
2. FEV1 > 80 % of that predicted for gender, ethnicity, age and height.
3. FEV1/FVC ratio > 80 % of predicted values
4. Oxygen saturation > 94 %.
5. Total symptom Score no greater than 20 (out of a possible 60-see accompanying score sheet) with a value no greater than 3 for any one score. No more than one score may be equal to 3.

Exclusion Criteria:

1. Individuals with a diagnosis of COVID-19 and/or hospitalized for COVID-19.
2. Individuals who are not "up to date," \[meaning a person has received all recommended COVID-19 vaccines, including any booster dose(s) when eligible with their COVID vaccines as defined by the CDC.\]
3. A history of acute and chronic cardiovascular disease, chronic respiratory disease, diabetes,rheumatologic diseases, immunodeficiency state.
4. An acute respiratory illness within 4 weeks.
5. Subjects who are asthmatic or have a history of asthma.
6. Allergic to chemical vapors or gases.
7. Any allergic symptoms during the time of participation in the study
8. Female subjects who are currently pregnant, attempting to become pregnant or breastfeeding
9. Subjects currently taking mega doses of vitamins and supplements, homeopathic/naturopathic medicines or 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). Medications not specifically mentioned here may be reviewed by the investigators prior to a subject's inclusion in the study.
10. Current and past smokers within 2 years, or subjects with a smoking history of at least a pack of cigarettes a day for more than 10 years over your lifetime. This includes vaping, hookah,and e-cigarettes.
11. Uncontrolled hypertension (> 140 systolic, > 90 diastolic). Blood pressure readings equal to or greater that 140 Systolic and equal to or greater that 90 diastolic.
12. Subjects who do not understand or speak English
13. Unspecified illnesses, which in the judgment of the investigator might increase the risk associated with ozone inhalation challenge or exercise, will be a basis for exclusion.

Temporary exclusion criteria:

1. Individuals who have had an acute respiratory illness within 4 weeks.
2. Individuals who have active allergies.
3. Individuals that have engaged in strenuous exercise within 24 hours of any study visit.
4. Individuals unable to avoid drinking alcohol for 24 hours prior to all study visits.
5. Individuals who have been exposed to smoke and fumes for 24 hours before all visits.
6. Individuals that have used an ozone-based home air purifier for 24 hours before all visits.
7. Individuals that have eaten or drank anything for 2 hours prior to the sputum training/screening day visit.
8. Individuals should avoid caffeine for 12 hours prior to all study visits.
9. Individuals should refrain from all over the counter anti-inflammatory agents including those for allergies, and anti-inflammatory drugs or antioxidants for a period of one week prior to the train and to the exposure.
10. Individuals that have been exposed to or have consumed any agent or have undertaken any activity within 24 hours of any study visit that the investigators believe may compromise the results of the study.

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Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 0.070 ppm ozone concentration

Exposure to 0.070 ppm ozone for 6.6 hours while performing moderate intermittent exercise.

experimental: Clean air (0.0 ppm ozone)

Exposure to clean air (0.0 ppm ozone) for 6.6 hours while performing moderate intermittent exercise.

Interventions

0.070 ppm ozone concentration

The concentration of ozone a subject will randomly receive on a visit for 6.6 hours in a controlled atmospheric chamber while performing moderate intermittent exercise.

Clean air (0.0 ppm ozone)

Same subject will randomly receive clean air on another visit separated by at least one week for 6.6 hours in the same controlled atmospheric chamber while performing moderate intermittent exercise.

Primary outcome measure

  • FVC [ Time Frame: measured (pre) before starting 6.6 hours of exercise ]
  • Change in FVC [ Time Frame: change measured (post) immediately after 6.6 hours of exercise ]
  • FEV1 [ Time Frame: measured (pre) before starting 6.6 hours of exercise ]
  • Change in FEV1 [ Time Frame: change measured (post) immediately after 6.6 hours of exercise ]

Central Contacts and Locations

Central contacts

Locations

EPA Human Studies Facility

Recruiting

Chapel Hill, North Carolina, United States, 27599-7315

Contacts

More Information

Sponsor

Martin W. Case

Last update posted

Jan 11, 2023

Last verified

Jan, 2023

Keywords

  • lungs
  • ozone concentration
  • exercise
  • inflammation
  • symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Martin W. Case on 2023-01-11.