RECRUITING

Pulmonary and Inflammatory Responses Following Exposure to a Low Concentration of Ozone or Clean Air

Conditions

Lung Injury, Acute Symptoms and Signs Neutrophilia Acute lungs ozone concentration exercise inflammation symptoms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pulmonary and Inflammatory Responses Following Exposure to a Low Concentration of Ozone or Clean Air for 6.6 Hours With Moderate Exercise in Healthy Young Adults

Quick Facts

Study Start:2022-10-13

Study Completion:2025-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05680831

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 35 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Martin W Case, B.S.

CONTACT

919-966-6211

case.martin@epa.gov

Andrea Davis, R.N.

CONTACT

919-966-6241

davis.andrea@epa.gov

Principal Investigator

Andy Ghio, M.D.

PRINCIPAL_INVESTIGATOR

EPA/ORD/CPHEA/PHITD/CRB

Study Locations (Sites)

EPA Human Studies Facility

Chapel Hill, North Carolina, 27599-7315

United States

Collaborators and Investigators

Sponsor: Martin W. Case

Andy Ghio, M.D., PRINCIPAL_INVESTIGATOR, EPA/ORD/CPHEA/PHITD/CRB

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-13

Study Completion Date2025-02-01

Study Record Updates

Study Start Date2022-10-13

Study Completion Date2025-02-01

Terms related to this study

Keywords Provided by Researchers

lungs
ozone concentration
exercise
inflammation
symptoms

Additional Relevant MeSH Terms

Lung Injury, Acute
Symptoms and Signs
Neutrophilia Acute