Lung Macrophage Populations and Functions in Chronic Obstructive Pulmonary Disease (COPD)-Susceptible Smokers
Recruiting · NCT04722835 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of California, San Francisco
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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.
Where it is running
3 locations listed across 1 US state.
- Zuckerberg San Francisco General Hospital and Trauma Center - San Francisco, California, United States
- San Francisco VA Medical Center - San Francisco, California, United States
- University of California, San Francisco - San Francisco, California, United States