Innate Immunity in Ozone-induced Airway Inflammation in COPD (NCT04669743) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Innate Immunity in Ozone-induced Airway Inflammation in COPD
United States72 participantsStarted 2016-04-07
Plain-language summary
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the United States. Patients with COPD are routinely exposed to indoor and outdoor air pollution, which appears to cause escalation of their respiratory symptoms, a process called exacerbation, with resulting need to seek medical attention. This research plan proposes to evaluate the impact of lung immune cells in susceptibility to develop exacerbation through an experimental model of inhalational exposure using ambient levels of a component of air pollution (ozone) in COPD patients and longitudinal sampling of their lung immune cells.
Who can participate
Age range
45 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. No diagnosis of COPD or asthma.
. No spirometric evidence of airflow obstruction as determined by FEV1/FVC ratio = or \>0.7.
. Less than 1 pack year history of tobacco smoking and no tobacco use within the past 12 months.
. No diagnosis of COPD or asthma.
. No spirometric evidence of airflow obstruction as determined by FEV1/FVC ratio = or \>0.7.
. Current smoker with history of at least 20 pack-years smoking.
. Diagnosis of COPD as determined by GOLD criteria (FEV1/FVC ratio \<0.7).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in prevalence and functional status of alveolar macrophage sub-populations in airway lumen
Timeframe: 4 weeks
2
Changes in prevalence and functional status of monocyte-derived macrophage sub-populations in airway lumen
Timeframe: 4 weeks
3
Changes in prevalence and functional status of interstitial macrophage sub-populations in airway lumen
. COPD severity of GOLD stage II or III (FEV1 \>40% predicted).
Exclusion criteria
. History of IV drug use or inhalation of recreational drugs other than marijuana:
. COPD severity of GOLD stage IV.
. 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).
. Pregnant/breast feeding.
. 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.
. 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.