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

NCT06943989 | Enrolling By Invitation

• 1 other identifier: EnvironmentalPA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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 at rest. This concentration is the current EPA NAAQS standard for ozone.

Conditions

Lung Inflammation; Experimental Lung Inflammation

Outcome Measures

Primary Outcomes (2)

• FVC

  forced vital capacity

  measured (pre) before starting 6.6 hours of exposure, , immediately after (post), and at follow up 24 hours later (Follow Up)

• FEV1

  forced expiratory volume in 1 second

  measured (pre) before starting 6.6 hours of exposure, , immediately after (post), and at follow up 24 hours later (Follow Up)

Secondary Outcomes (2)

• % neutrophils collected by induced sputum

  18 hours post exposure

• Nasal Epithelial Lavage Fluid (NELF)

  measured (pre) before starting 6.6 hours of exposure, , immediately after (post), and at follow up 24 hours later (Follow Up)

Study Arms (2)

0.070 ppm ozone concentration

EXPERIMENTAL

Exposure to 0.070 ppm ozone for 6.6 hours at rest

Other: Ozone Exposure

Clean air (0.0 ppm ozone)

EXPERIMENTAL

Exposure to clean air (0.0 ppm ozone) for 6.6 hours while at rest

Other: Clean air (0.0 ppm ozone)

Interventions

Ozone Exposure OTHER

6.6 hour exposure to 0.07 ppm ozone while at rest

0.070 ppm ozone concentration

Clean air (0.0 ppm ozone) OTHER

6.6 hour exposure to clean air (0.00 ppm ozone) while at rest

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:

• Age 18-35 years old healthy male and female.
• No concerning findings on electrocardiogram (ECG) and no history of serious heart arrythmia.
• Normal lung function based on current American Thoracic Society(ATS) criteria.
• Forced vital capacity (FVC) 80% of that predicted for age, gender and height.
• Forced expiratory volume in one second (FEV1) 80% of that predicted for age, gender and height.
• FEV1/FVC absolute ratio of at least 70%.
• Oxygen saturation normal (94%) at the time of physical exam.

You may not qualify if:

• A history of acute or chronic cardiovascular disease, chronic respiratory disease, a history of hospitalization for COVID-19, diabetes, rheumatologic diseases, immunodeficiency state.
• Active asthma or a history of asthma within the past ten years (by spirometry, medication use
• and/or symptoms).
• Allergy to chemical vapors or gases.
• Currently pregnant, attempting to become pregnant or breastfeeding.
• The use of high doses of vitamins and supplements, homeopathic/naturopathic medicines or medications (e.g., steroids, beta blockers) which may impact the results of the ozone challenge or interfere with any other medications potentially used in the study.
• Active smoker or smoking within the previous 2 years, or participants with a lifetime smoking
• history equivalent to 10 pack-years or greater. This includes vaping, hookah use and e-cigarette use.
• Uncontrolled hypertension (= 140 systolic, = 90 diastolic). Blood pressure readings equal to or greater that 140 Systolic and equal to or greater that 90 diastolic.
• Inability to communicate verbally in English.
• Unspecified illnesses or chronic conditions which, in the judgment of the investigators and EPA clinical staff, might increase the risk associated with ozone inhalation or affect the study outcome measurements.
• Individuals who have had an acute respiratory illness within 4 weeks.
• Individuals who have active allergic rhinitis and/or conjunctivitis.
• Individuals unable to avoid drinking alcohol for 24 hours prior to all study visits.
• Individuals who have been exposed to smoke and fumes for 24 hours before all visits.

Sponsors & Collaborators

• Environmental Protection Agency (EPA): lead

Study Sites (1)

EPA Human Studies Facility

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Biologist

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 25, 2025
• Study Start: November 5, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)