Lung Macrophage Populations and Functions in Chronic Obstructive Pulmonary Disease (COPD)-Susceptible Smokers
Pre-COPD Pilot
1 other identifier
observational
40
1 country
3
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2021
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2020
CompletedFirst Posted
Study publicly available on registry
January 25, 2021
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
June 4, 2026
June 1, 2026
9.8 years
December 9, 2020
June 1, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Prevalence of macrophage sub-populations in airway lumen.
Number of macrophages measured by flow cytometry.
4 weeks
Functional status of macrophage sub-populations in airway lumen.
Relative percentage of macrophages measured by flow cytometry.
4 weeks
Secondary Outcomes (1)
Symptomatic responses
1 day
Study Arms (2)
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.
Interventions
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.
Eligibility Criteria
The investigators will recruit both healthy, non-smoking subjects as well as subjects with at least 20 pack-years of smoking and air trapping.
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:
- 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.
You may not qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110, United States
San Francisco VA Medical Center
San Francisco, California, 94121, United States
University of California, San Francisco
San Francisco, California, 94122, United States
Biospecimen
10 tablespoons of blood as well as Bronchoalveolar Lavage (BAL) samples will be collected.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mehrdad Arjomandi, MD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2020
First Posted
January 25, 2021
Study Start
March 1, 2021
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
June 4, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share