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Ozone Exposure for COPD (CO3PD Trial)
N/A
Waitlist Available
Led By Mehrdad Arjomandi, M.D.
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Less than 1 pack year history of tobacco smoking and no tobacco use within the past 12 months.
Group 4: Diagnosis of COPD as determined by GOLD criteria (FEV1/FVC ratio <0.7). COPD severity of GOLD stage II or III (FEV1 >40% predicted). Smoking Status: Current smokers with history of at least 20 pack-years smoking.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
CO3PD Trial Summary
This trial will study how exposure to air pollution affects COPD patients by observing how their lung cells react.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Ozone exposure may lead to increased respiratory symptoms like coughing and shortness of breath, irritation in the throat or chest discomfort. These effects can vary based on individual health status and severity of existing respiratory conditions.
CO3PD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have smoked less than 1 pack-year and haven't used tobacco in the last year.
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I have moderate to severe COPD, am a current smoker with a 20 pack-year history.
Select...
I have smoked at least 20 pack-years.
Select...
I have never been diagnosed with COPD or asthma.
CO3PD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in prevalence and functional status of alveolar macrophage sub-populations in airway lumen
Changes in prevalence and functional status of interstitial macrophage sub-populations in airway lumen
Changes in prevalence and functional status of monocyte-derived macrophage sub-populations in airway lumen
Secondary outcome measures
Cardiovascular response using measurement of Blood Pressure
Cardiovascular response using measurement of ECG changes
Cardiovascular response using measurement of Heart Rate
+2 moreCO3PD Trial Design
1Treatment groups
Experimental Treatment
Group I: Study PopulationExperimental Treatment1 Intervention
Subjects will be recruited and consented following screening. Subjects will be characterized into cohorts based on presence of COPD and smoking status. All subjects enrolled will be undergoing the same interventions: 1st Bronchoscopy (3 wks pre-exposure), Ozone Exposure, 2nd Bronchoscopy (1 day post-exposure), 3rd Bronchoscopy (5 days post-exposure). Ozone exposure will take place in an exposure chamber.
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,483 Total Patients Enrolled
35 Trials studying Asthma
20,354 Patients Enrolled for Asthma
Mehrdad Arjomandi, M.D.Principal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
590 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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 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.I have a serious heart condition, such as recent heart attack or unstable angina.My BMI is under 19, or I have a history of malnourishment but my albumin level is above 2.5 mg/dL.My COPD is very severe.I have moderate to severe COPD, am a current smoker with a 20 pack-year history.I cannot do moderate exercise like brisk walking or cycling.I don't have COPD or asthma, never smoked more than 1 pack-year, and haven't smoked in the last year.I am a current smoker with at least 20 years of smoking history and do not have COPD, asthma, or airflow obstruction.I have COPD according to the GOLD criteria after an Albuterol test.I can arrange for someone to take me home after treatments that require sedation.I have smoked at least 20 pack-years.You currently smoke or have a history of smoking at least 20 packs of cigarettes in your lifetime.I have never been diagnosed with COPD or asthma.Your lungs must be working well, which will be checked by a breathing test.
Research Study Groups:
This trial has the following groups:- Group 1: Study Population
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment process still open for this clinical trial?
"According to the clinicaltrials.gov website, this trial is not currently accepting new patients. The initial posting date was April 7th 2016 and it has been updated as recently as June 6th 2022. Despite this study's inactivity, there are still 692 other trials that are open for enrolment at present."
Answered by AI
May I be admitted as a participant to this clinical trial?
"In order to join this clinical trial, potential participants should have breathing difficulties and be between 45 and 75 years of age. The researchers are currently enrolling a cohort of 72 individuals."
Answered by AI
Does this trial encompass individuals of 25 years and older?
"This research requires participants aged 45 to 75. There are 53 studies recruiting patients under 18, and 584 trials seeking volunteers over 65 years old."
Answered by AI
What are the key aims of this clinical investigation?
"This clinical trial is estimated to last 4 weeks and aims to assess the prevalence and functional status of airway lumen-located interstitial macrophage populations. Secondary objectives include tracking symptomatic responses, measuring cardiovascular changes in blood pressure, as well as assessing physiologic alterations caused by ozone exposure."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Zuckerberg San Francisco General Hospital and Trauma Center
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