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

NCT05680831 | Unknown Phase 1 FDA Drug

• 1 other identifier: IRB# 21-3193
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

lungs; ozone concentration; exercise; inflammation; symptoms

Outcome Measures

Primary Outcomes (4)

• FVC

  forced vital capacity

  measured (pre) before starting 6.6 hours of exercise

• Change in FVC

  change in forced vital capacity

  change measured (post) immediately after 6.6 hours of exercise

• FEV1

  forced expiratory volume in 1 second

  measured (pre) before starting 6.6 hours of exercise

• Change in FEV1

  change in forced expiratory volume in 1 second

  change measured (post) immediately after 6.6 hours of exercise

Secondary Outcomes (2)

• % neutrophils collected by induced sputum

  baseline: training/qualification day

• change in % neutrophils collected by induced sputum

  18 hours post exposure

Study Arms (2)

0.070 ppm ozone concentration

EXPERIMENTAL

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

Biological: 0.070 ppm ozone concentration

Clean air (0.0 ppm ozone)

EXPERIMENTAL

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

Biological: Clean air (0.0 ppm ozone)

Interventions

0.070 ppm ozone concentration BIOLOGICAL

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.

0.070 ppm ozone concentration

Clean air (0.0 ppm ozone) BIOLOGICAL

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.

Clean air (0.0 ppm ozone)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women between 18 and 35 years of age.
• Physical conditions allowing sustained moderate exercise for 6.6 hours.
• Normal lung function (NHANES III):
• FVC \> 80 % of that predicted for gender, ethnicity, age and height.
• FEV1 \> 80 % of that predicted for gender, ethnicity, age and height.
• FEV1/FVC ratio \> 80 % of predicted values
• Oxygen saturation \> 94 %.
• 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.

You may not qualify if:

• Individuals with a diagnosis of COVID-19 and/or hospitalized for COVID-19.
• Individuals who are not "up to date," \[meaning a person has received all recommended COVID-19 vaccines, including any booster dose(s) when eligible with their COVID vaccines as defined by the CDC.\]
• A history of acute and chronic cardiovascular disease, chronic respiratory disease, diabetes,rheumatologic diseases, immunodeficiency state.
• An acute respiratory illness within 4 weeks.
• Subjects who are asthmatic or have a history of asthma.
• Allergic to chemical vapors or gases.
• Any allergic symptoms during the time of participation in the study
• Female subjects who are currently pregnant, attempting to become pregnant or breastfeeding
• 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.
• Uncontrolled hypertension (\> 140 systolic, \> 90 diastolic). Blood pressure readings equal to or greater that 140 Systolic and equal to or greater that 90 diastolic.
• Subjects who do not understand or speak English
• Individuals who have had an acute respiratory illness within 4 weeks.
• Individuals who have active allergies.
• Individuals that have engaged in strenuous exercise within 24 hours of any study visit.
• Individuals unable to avoid drinking alcohol for 24 hours prior to all study visits.

Sponsors & Collaborators

• Martin W. Case: lead
• University of North Carolina: collaborator

Study Sites (1)

EPA Human Studies Facility

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

RECRUITING

MeSH Terms

Conditions

Acute Lung Injury; Signs and Symptoms; Motor Activity; Inflammation

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Pathologic Processes

Study Officials

• Andy Ghio, M.D.

  EPA/ORD/CPHEA/PHITD/CRB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: TRC Environmental Corporation, who is on-site contractor responsible for the exposure operation will randomize the subjects into either air or ozone arms, neither subjects nor staff involved in conduct of experiments will be informed of exposure conditions.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Studies Coordinator

Model Details: This is a randomized, double-blind, cross-over study with two arms.

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 11, 2023
• Study Start: October 13, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2025
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)