What this study is
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.
What's being tested
- Bronchoscopy with Bronchoalveolar Lavage (BAL)
Intervention · PROCEDURE
1. Bronchoscopy w/ (BAL): The bronchoscope will be introduced through mouth and directed into the right middle lobe bronchus for bronchial lavage. The BAL will be performed with two 60-mL aliquots (total of 120 ml) of saline in each of medial and lateral segments of Right Middle Lobe (RML) (total 240 ml lavage). 2. Albuterol Administration: The subjects will inhale 2 puffs of respiratory medication albuterol, then repeat the breathing test. 3. Peak Flow Measurement: Subjects will breathe in fully then out forcefully into the handheld device. 4. Pulmonary Function Test w/ Spirometry: will be used for determination of COPD and its severity. The PFT measures breathing capacity and lung function with different types of breathing maneuvers including flow-volume curve, single breath CO diffusing capacity, and total lung capacity. 5. Blood draw 6. Medical Health and Symptom Questionnaires 7. Physical Exam by study doctor to determine suitability and safety for participation.
Study details
- Sponsor
- University of California, San Francisco
- Conditions
- Copd · Smoking · Tobacco Use
- Enrolling
- 40 people
- Starts
- 2021-03-01
- Est. completion
- 2030-12-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years – 75 YearsSex ALLHealthy volunteers AcceptedNormal RV/TLC Group
You may qualify if
- 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:
- Plethysmographic RV/TLC equal or less than lower limit of normal.
You can't join if
- 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.
Abnormal RV/TLC Group
You may qualify if
- 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:
- Plethysmographic RV/TLC higher than lower limit of normal.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
1 openSan Francisco VA Medical Center
San Francisco, California, United States
- Yorusaliem Abrham · Contact415-221-4810 ext. 24269yorusaliem.abrham@ucsf.edu
- Mehrdad Arjomandi, M.D. · Principal investigator
RecruitingZuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States
Active, not recruitingUniversity of California, San Francisco
San Francisco, California, United States
Active, not recruiting
Study team
Sponsor
University of California, San Francisco
Study ID 19-29768
Principal investigator
Mehrdad Arjomandi, MD
University of California, San Francisco
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.