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Scientists expose COPD patients to ozone to uncover Pollution's hidden impact

NCT ID NCT04669743

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how ozone, a common air pollutant, affects immune cells in the lungs of people with COPD. Researchers will expose 72 participants (including healthy non-smokers, smokers without COPD, and COPD patients) to ozone in a controlled chamber and track changes in their lung immune cells. The goal is to understand why pollution triggers COPD flare-ups, which could lead to better prevention strategies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ozone exposure
What this could lead to
If successful, this could help explain why air pollution worsens COPD symptoms, pointing toward new ways to prevent flare-ups.
What could go wrong
This is an early observational study with no treatment being tested. Results may not lead to direct patient benefits or apply to real-world pollution scenarios.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2016

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Group 1: 1. No diagnosis of COPD or asthma. 2. No spirometric evidence of airflow obstruction as determined by FEV1/FVC ratio = or \>0.7. 3. Less than 1 pack year history of tobacco smoking and no tobacco use within the past 12 months. Group 2: 1. No diagnosis of COPD or asthma. 2. No spirometric evidence of airflow obstruction as determined by FEV1/FVC ratio = or \>0.7. 3. Current smoker with history of at least 20 pack-years smoking. Group 3: 1. Diagnosis of COPD as determined by GOLD criteria (FEV1/FVC ratio \<0.7). 2. COPD severity of GOLD stage II or III (FEV1 \>40% predicted). 3. Smoking Status: Former smokers with history of at least 20 pack-years smoking. Group 4: 1. Diagnosis of COPD as determined by GOLD criteria (FEV1/FVC ratio \<0.7). 2. COPD severity of GOLD stage II or III (FEV1 \>40% predicted). 3. Smoking Status: Current smokers with history of at least 20 pack-years smoking. During subject screening visit, Albuterol is used to determine whether the subjects have COPD based on the Global Initiative on Obstructive Lung Diseases (GOLD) criteria. Regardless of whether the subject has reversibility to Albuterol or not, if they have an abnormal ratio after inhalation of Albuterol, they would meet the GOLD criteria for COPD and will be included in the study. Exclusion Criteria: 1. History of IV drug use or inhalation of recreational drugs other than marijuana: A- within the past 20 years. B- more than 100 usage. C- longer than 1 year. 2. COPD severity of GOLD stage IV. 3. Inability to walk briskly or run on treadmill or pedal on ergometer to perform the study-required moderate exercise level (achieve minute ventilation of 15 to 20 L/min/m2 body surface area). 4. Pregnant/breast feeding. 5. Serious and active heart conditions - defined by stable or unstable angina, recent myocardial infarction (within the last 2 years), active congestive heart failure, ischemic cardiomyopathy. 6. Malnourishment - determined by BMI less than 19. If subject has BMI greater or equal to 19, but has a history of malnourishment, study staff will measure albumin level of subject's blood after initial blood draw. Albumin level must be greater than 2.5 mg per deciliter, or subject will be excluded. 7. Liver cirrhosis. 8. History of chronic active Hepatitis B or C 9. On visits where moderate sedation is preformed, subject are required to have an escort home. Inability to secure a ride home will result in the subject being ineligible for the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • San Francisco VA Medical Center

    San Francisco, California, 94121, United States

  • University of California, San Francisco

    San Francisco, California, 94122, United States

  • Zuckerberg San Francisco General Hospital and Trauma Center

    San Francisco, California, 94110, United States

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