Ozone Exposure for COPD

(CO3PD Trial)

Not currently recruiting at 2 trial locations
YA
HL
Overseen ByHelen Lozier, B.A.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to investigate how exposure to ozone, a common air pollutant, affects lung health in people with chronic obstructive pulmonary disease (COPD). Researchers seek to understand how ozone exposure might worsen respiratory symptoms by examining lung immune cells before and after exposure. Suitable candidates for this study include individuals with COPD who have a smoking history of at least 20 pack-years and are either current or former smokers. Participants should not have severe COPD or certain heart conditions. As an unphased trial, this study offers participants the opportunity to contribute to important research that could enhance the understanding and management of COPD.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that ozone exposure is safe for COPD patients?

Research has shown that ozone, a component of air pollution, can affect individuals with COPD (chronic obstructive pulmonary disease). Studies have found that short-term ozone exposure increases the likelihood of hospital visits for those with COPD. For instance, one study found that this exposure can lead to more frequent flare-ups or worsening symptoms in individuals with lung diseases like COPD and asthma.

Another study found that long-term ozone exposure is linked to a higher risk of death from COPD in older adults. However, these findings are based on data from large groups, not from individual exposure in controlled settings like clinical trials.

In summary, while ozone exposure has been linked to negative effects in COPD, the safety of controlled ozone exposure for research remains under study. Participants should consider these findings and discuss any concerns with the research team before joining a trial.12345

Why are researchers excited about this trial?

Unlike traditional treatments for COPD that often focus on bronchodilators and steroids to manage symptoms, ozone exposure is being explored for its potential to directly influence lung function. Researchers are excited because this approach involves a novel mechanism of action—introducing controlled ozone exposure in a specialized chamber, which might alter inflammatory responses and potentially improve lung health. This method could pave the way for innovative strategies that enhance lung repair and resilience, offering hope for more effective management of COPD symptoms.

What evidence suggests that ozone exposure is effective for studying COPD exacerbation?

Research has shown that ozone, a component of air pollution, can worsen symptoms for people with COPD. Studies have found that long-term exposure to high ozone levels is linked to more frequent COPD flare-ups, resulting in more hospital visits. One study discovered that prolonged ozone exposure can impair breathing by damaging lung function. Additionally, evidence suggests that high ozone levels can increase the risk of dying from COPD. These findings raise concerns about ozone's impact on lung health in people with COPD. Participants in this trial will undergo controlled ozone exposure to further investigate these effects.36789

Who Is on the Research Team?

MA

Mehrdad Arjomandi, M.D.

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults with COPD stages II or III, current or former smokers with a significant smoking history. It includes those without COPD as controls. Excluded are individuals with severe COPD (stage IV), pregnant women, the malnourished, those with serious heart conditions, liver cirrhosis, chronic hepatitis B/C, and recent drug users.

Inclusion Criteria

I have smoked less than 1 pack-year and haven't used tobacco in the last year.
I have moderate to severe COPD, used to smoke a lot, but I've quit.
I have moderate to severe COPD, am a current smoker with a 20 pack-year history.
See 7 more

Exclusion Criteria

I have liver cirrhosis.
I have a history of chronic Hepatitis B or C.
You have used illegal drugs by injecting them into your veins or inhaling them (excluding marijuana) in the past 20 years, more than 100 times, or for longer than 1 year.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-exposure Assessment

Participants undergo the first bronchoscopy 3 weeks before ozone exposure to assess baseline lung immune cell status

3 weeks
1 visit (in-person)

Ozone Exposure

Participants are exposed to controlled ozone levels in an exposure chamber to study airway injury and inflammation

1 day
1 visit (in-person)

Post-exposure Assessment

Participants undergo bronchoscopy 1 day and 5 days post-exposure to evaluate changes in lung immune cells

1 week
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after ozone exposure, including cardiovascular and symptomatic responses

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ozone exposure

Trial Overview

The study investigates how lung immune cells in COPD patients respond to ozone exposure—a common air pollutant. Participants will be exposed to ambient levels of ozone and undergo tests to assess their immune response and any exacerbation of symptoms.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Study PopulationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Citations

Association between long-term ozone exposure and ...

Our findings indicate that long-term exposure to high O₃ concentrations is associated with an increased risk of AECOPD readmission over various ...

Combined effect of ozone and household air pollution ... - PMC

Long-term exposure to ozone is associated with impaired pulmonary function, adverse respiratory symptoms, increased hazard of COPD admissions, deterioration of ...

Demographic Differences in the All of Us Research Program

Overall, we observed a positive, non-monotonic relationship between ozone and COPD risk, driven by the highest quartile of exposure (HRQuartile ...

Effects of Chronic Ozone Exposure on Lung Function

This is the first detailed epidemiologic study of the effects of chronic exposure to an air pollutant based on individual estimates of lifetime exposure and ...

Air pollution and COPD: GOLD 2023 committee report

Exposure to ozone ... Home dust allergen exposure is associated with outcomes among sensitized individuals with chronic obstructive pulmonary disease.

A Systematic Review and Meta-Analysis of Short-Term ... - PMC

Our systematic review and meta-analysis indicate that short-term ambient level ozone exposure was associated with increased risk of COPD hospitalizations.

Ambient Ozone, Household Air Pollution Exposure Are ...

The study found that exposure to HAP increased the odds of developing COPD significantly (odds ratio [OR], 1.82; 95% CI, 1.41-2.37).

COPD deaths attributable to ozone in 2019 and future ...

Chronic obstructive pulmonary disease (COPD) is an epidemic in China. Ozone is a possible risk factor of COPD, with ozone concentrations increasing in China ...

Combined effect of ozone and household air pollution on ...

This study concludes that exposure to ambient O 3 and household air pollution might be important risk factors for COPD among young adults.