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

40 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Clean air (0.0 ppm ozone) for lung health?

Research indicates that exposure to ozone, even at low levels, can decrease lung function and increase respiratory symptoms. By reducing ozone exposure to 0.0 ppm, the treatment aims to prevent these negative effects, potentially improving lung health and reducing the risk of respiratory issues. ^{1 2 3 4 5}

Is ozone exposure generally safe for humans?

Ozone exposure, especially at high levels or over long periods, can cause lung function issues, respiratory symptoms, and inflammation. However, low concentrations of ozone, like those from air purifiers, have been shown to be safe in animal studies, with no significant health effects observed. ^{1 6 7 8 9}

How does the treatment of ozone exposure differ from other treatments for lung health?

This treatment is unique because it involves controlled exposure to ozone, a component of air pollution, to study its effects on lung health, rather than using a medication or traditional therapy. Unlike standard treatments that aim to improve lung function, this study focuses on understanding the impact of ozone exposure, which is typically considered harmful, especially for sensitive individuals. ^{2 5 10 11 12}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Dose-effect models for ozone exposure: tool for quantitative risk estimation. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Ozone. The good, the bad, and the ugly. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of ozone on lung function and lung diseases. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Allergen bronchoprovocation of patients with mild allergic asthma after ozone exposure. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Lung function and inflammatory responses in healthy young adults exposed to 0.06 ppm ozone for 6.6 hours. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Outdoor air pollution: ozone health effects. [2013]

7. Belgium pubmed.ncbi.nlm.nih.gov

[Ozone exposure and asthma]. [2015]

8. Germany pubmed.ncbi.nlm.nih.gov

[Health effects of ozone as component of summer smog]. [2013]

9. Germany pubmed.ncbi.nlm.nih.gov

Ozone generated by air purifier in low concentrations: friend or foe? [2018]

10. England pubmed.ncbi.nlm.nih.gov

A dose-response study of healthy, heavily exercising men exposed to ozone at concentrations near the ambient air quality standard. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

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

12. United States pubmed.ncbi.nlm.nih.gov

The acute effects of 0.2 ppm ozone in patients with chronic obstructive pulmonary disease. [2013]