Status:
UNKNOWN
Lung Macrophage Populations and Functions in Chronic Obstructive Pulmonary Disease (COPD)-Susceptible Smokers
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
United States Department of Defense
Conditions:
Copd
Smoking
Eligibility:
All Genders
40-75 years
Brief 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 unc...
Detailed Description
This is a pilot observational study of 20 subjects ≥40 years of age with smoking history of at least 20 pack-years (former or current) who have preserved spirometry, as defined by normal Forced Expira...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04722835
Start Date
March 1 2021
End Date
December 31 2022
Last Update
June 8 2022
Active Locations (3)
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1
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States, 94110
2
San Francisco VA Medical Center
San Francisco, California, United States, 94121
3
University of California, San Francisco
San Francisco, California, United States, 94122