Ozone Exposure for Lung Health

(LOCONOZ3 Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Environmental Protection Agency (EPA)

Must not be taking: Steroids, Beta blockers

Disqualifiers: Cardiovascular, Respiratory, Diabetes, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study the effects of breathing low levels of ozone, similar to current air quality standards, on lung function and symptoms in healthy young adults. Participants will spend approximately 6.6 hours in a controlled setting, breathing either clean air (0.0 ppm ozone) or air with a small amount of ozone. This study is ideal for individuals aged 18-35 who are healthy, have no history of heart or lung issues, and do not smoke. As an unphased trial, it offers participants the opportunity to contribute to important research on air quality and health.

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications, such as high doses of vitamins, supplements, steroids, beta blockers, over-the-counter anti-inflammatory agents, antihistamines, and antioxidants, for a specific period before the study. Other medications not mentioned will be reviewed by the investigators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Breathing in ozone can affect lung function, even at low levels. Research has shown that ozone exposure can worsen asthma and cause lung problems, even in healthy individuals.

Some studies have found that spending several hours in ozone levels of 80 parts per billion (ppb) or higher can noticeably reduce lung function. Even at the level used in one study (70 ppb), there might be some effects on lung function, especially with repeated exposure.

Although the ozone level in this trial is low and meets current environmental standards, it's important to know that even these levels can impact the lungs. Consulting a healthcare provider about any concerns before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because they're exploring how different levels of ozone exposure might affect lung health, especially when participants are at rest. Unlike standard treatments for lung conditions, which often involve medication or inhalers to manage symptoms, this study is looking at the impact of something as simple as the air we breathe. By comparing clean air with air containing a small amount of ozone, researchers hope to understand the potential risks or benefits of ozone exposure. This could lead to new insights into how environmental factors influence lung health and inform future health guidelines.

What evidence suggests that this trial's treatments could be effective for lung health?

Research has shown that exposure to ozone, even at low levels like 0.070 parts per million (ppm), can impair lung function. This trial will compare the effects of exposure to 0.070 ppm ozone with exposure to clean air (0.0 ppm ozone). Studies have found that even small amounts of ozone can cause airway swelling and temporarily make breathing more difficult. For instance, one study found that inhaling ozone can lead to increased coughing and throat irritation. While breathing clean air (0.0 ppm ozone) does not cause these issues, ozone exposure is linked to breathing problems and other health concerns, even in healthy adults. This evidence suggests that even low levels of ozone can harm lung health. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy young adults who can participate in a study measuring lung function and inflammation after being exposed to low-level ozone or clean air. Specific eligibility details are not provided, so general good health may be assumed.

Inclusion Criteria

FEV1/FVC absolute ratio of at least 70%

Oxygen saturation normal (94%) at the time of physical exam

My heart's rhythm is normal and I've never had serious irregular heartbeats.

Exclusion Criteria

Allergy to chemical vapors or gases

Currently pregnant, attempting to become pregnant, or breastfeeding

Individuals who will NOT comply with the temporary exclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Exposure

Participants are exposed to either 0.070 ppm ozone or clean air for 6.6 hours at rest

1 day

1 visit (in-person)

Immediate Post-Exposure Assessment

Pulmonary function and inflammatory responses are measured immediately after exposure

Same day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness 24 hours after exposure

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Clean air (0.0 ppm ozone)
• Ozone Exposure

Trial Overview

The study investigates the effects of breathing in a small amount of ozone (0.070 ppm), which is the EPA's standard limit, compared to breathing clean air. Participants will be exposed for about 6.6 hours while resting to see how it affects their lungs and symptoms.

How Is the Trial Designed?

Group I: Clean air (0.0 ppm ozone) Experimental Treatment 1 Intervention

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

Group II: 0.070 ppm ozone concentration Experimental Treatment 1 Intervention

Exposure to 0.070 ppm ozone for 6.6 hours at rest

Who Is Running the Clinical Trial?

Environmental Protection Agency (EPA)

Lead Sponsor

Trials

40

Recruited

95,500+

Published Research Related to This Trial

Short-term exposure to ozone can lead to immediate negative effects on lung function, increased airway inflammation, and higher rates of respiratory symptoms and hospital admissions.

Long-term exposure to elevated ozone levels is linked to chronic lung function decline, worsening asthma symptoms, and changes in airway cells and tissues, highlighting the need for quantitative health risk assessments using exposure-dose-response models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-effect models for ozone exposure: tool for quantitative risk estimation. van Bree, L., Marra, M., van Scheindelen, HJ., et al.[2019]

Exposure to elevated levels of ozone (O3) can lead to reversible reductions in lung function and symptoms like airway hyperreactivity and lung inflammation, particularly during summer months in urban areas.

The US Environmental Protection Agency has set a revised standard for ozone levels (0.08 ppm over 8 hours) to protect vulnerable populations, reflecting the recognized health risks associated with ozone exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of ozone on lung function and lung diseases. Uysal, N., Schapira, RM.[2019]

Ozone is a challenging air pollutant to control, and even healthy individuals can experience respiratory symptoms and reversible lung function effects during high summer concentrations, especially with heavy outdoor exercise.

While prolonged exposure to ozone can lead to increased airway responsiveness and inflammation, no specific 'high-risk' group has been identified, unlike with other pollutants such as sulfur dioxide, and ongoing studies are investigating potential chronic effects of ozone exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ozone, air pollution, and respiratory health. Beckett, WS.[2018]

Ground-level ozone is a respiratory irritant that can decrease lung function and is linked to various respiratory health issues, highlighting its potential dangers to public health.

While some studies suggest that short-term increases in ozone levels may lead to higher rates of cardiopulmonary mortality, other research has found no clear connection, indicating that the effects of ozone exposure can be complex and influenced by other pollutants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outdoor air pollution: ozone health effects. Chen, TM., Gokhale, J., Shofer, S., et al.[2013]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8783034/

Systematic Review of Ozone Effects on Human Lung ...

Multihour ozone levels of 80 ppb or higher consistently produce significant decreases in lung function in healthy adults. ... At the time of the 2013 EPA review, ...

2.

epa.gov

epa.gov/ozone-pollution-and-your-patients-health/health-effects-ozone-general-population

Health Effects of Ozone in the General Population

Higher daily ozone concentrations are associated with increased asthma attacks, increased hospital admissions, increased daily mortality, and other markers of ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2773049225000157

The dose-dependent effect of acute ozone exposure on ...

Our results showed that 0.2 ppm ozone was the maximum tolerated dose that elicited a temporal decline in lung function in healthy participants and that BerriQi ...

4.

atsjournals.org

atsjournals.org/doi/10.1164/rccm.202006-2597LE

Respiratory Effects of Sedentary Ozone Exposure at the 70 ...

Ozone causes neutrophilic airway inflammation, transient reductions in lung function, and increased respiratory symptoms upon acute exposure (3). Concentration ...

5.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa0803894

Long-Term Ozone Exposure and Mortality

For every 10-ppb increase in exposure to ozone, we observed an increase in the risk of death from respiratory causes of about 2.9% in single-pollutant models ...

6.

nj.gov

nj.gov/health/eoh/rtkweb/documents/fs/1451.pdf

Ozone

HAZARD SUMMARY. * Ozone can affect you when breathed in. * Ozone may cause mutations. Handle with extreme caution. * Ozone can cause reproductive damage.

7.

aaaai.org

aaaai.org/about/news/news/lung

Even Sedentary, Lung Function Drops After Ozone Exposure

The NAAQS of 0.07 ppm likely does not adequately protect the general healthy adult population, and in particular women, from repeated long-term ...

8.

matracking.ehs.state.ma.us

matracking.ehs.state.ma.us/Environmental-Data/Air-Quality/Ground_Level_Ozone.html

Outdoor Air Quality - Ground-Level Ozone

Breathing air containing ground-level ozone can reduce lung function and aggravate asthma or other respiratory ailments.