Lung Macrophage Populations and Functions in Chronic Obstructive Pulmonary Disease (COPD)-Suscept… (NCT04722835) | Clinical Trial Compass
RecruitingNot Applicable
Lung Macrophage Populations and Functions in Chronic Obstructive Pulmonary Disease (COPD)-Susceptible Smokers
United States40 participantsStarted 2021-03-01
Plain-language summary
Chronic Obstructive Pulmonary Disease (COPD) is a heterogeneous disease that affects only a fraction of those who smoke tobacco. The origin of this variability in susceptibility to develop COPD is unclear, but understanding its underlying biology has important implications for our ability to design suitable preventative and therapeutic strategies for its management. This Department of Defense (DOD) discovery research proposes to develop methodologies and generate preliminary data needed to lay the foundation for a large study that would investigate the underlying biological susceptibility of those who smoke tobacco to develop COPD.
Who can participate
Age range
40 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:
* Ages between 40 to 75 years old.
* History of at least 20 pack-years of smoking.
* No diagnosis of COPD or asthma.
* No spirometric evidence of airflow obstruction as determined by FEV1/FVC ratio ≥0.7.
* FEV1 and FVC \>lower limit of normal.
* Less than 1 pack-year history of tobacco smoking and no tobacco use within the past 12 months.
* Subjects will be divided into two groups by their RV/TLC:
Normal RV/TLC Group:
• Plethysmographic RV/TLC equal or less than lower limit of normal.
Abnormal RV/TLC Group:
• Plethysmographic RV/TLC higher than lower limit of normal.
Exclusion Criteria:
* Any history of IV drug use or inhalation of recreational drugs other than marijuana: A- within the past 20 years. B- more than 100 times IV drug usage. C- longer than 1 year usage.
* Marijuana use \>400 joints in lifetime or any within past 6 months.
* Inability to walk briskly, run on treadmill, or pedal on ergometer to perform the study-required exercise level.
* 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.
* Liver cirrhosis.
* History of chronic active Hepatitis B or C.
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
Prevalence of macrophage sub-populations in airway lumen.
Timeframe: 4 weeks
2
Functional status of macrophage sub-populations in airway lumen.