CopdPre-COPD PilotNCT04722835
Lung Macrophage Populations and Functions in Chronic Obstructive Pulmonary Disease (COPD)-Susceptible Smokers
An observational study of Copd and Smoking, run by University of California, San Francisco at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Copd, Smoking, Tobacco Use
- What is being tested?
- Bronchoscopy with Bronchoalveolar Lavage (BAL)
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2021to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators will recruit both healthy, non-smoking subjects as well as subjects with at least 20 pack-years of smoking and air trapping.
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 1 recruiting
- Active, not recruiting
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110
- Recruiting
San Francisco VA Medical Center
San Francisco, California, 94121
Yorusaliem Abrham, 415-221-4810 ext. 24269, yorusaliem.abrham@ucsf.edu
Mehrdad Arjomandi, M.D.
- Active, not recruiting
University of California, San Francisco
San Francisco, California, 94122
About this study
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.
Read the 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 Expiratory Volume (FEV1) / Forced Vital Capacity (FVC). Of the 20 subjects, 10 with and 10 without air trapping as determined by high and abnormal versus low and normal Residual Volume (RV) / Total Lung Capacity (TLC) measured by plethysmography. The cohort will undergo extensive clinical characterization including full Pulmonary Function Testing (PFT) and medical, symptom, activity, and quality of life questionnaires assessment including modified Medical Council Research (mMRC), COPD Assessment Test (CAT), Short Form-12 (SF12), and St. George's Respiratory (SGRQ) questionnaires. Subjects will undergo bronchoscopy with bronchoalveolar lavage (BAL) to obtain luminal macrophages and BAL fluid (BALF). Live BAL cells, BALF, and BAL cell RNA will be collected and stored in our biorepository for proposed studies. Molecular, functional, and transcriptomics analyses of luminal (alveolar) macrophages obtained by BAL (Aim 2) and protease activity measurement in serum and BALF will be performed (Aim 2) and will be examined against the clinical phenotype of the subjects, in particular air trapping-phenotype, to see if an underlying biological signature for susceptibility to develop COPD could be identified.
To perform a more comprehensive molecular and functional phenotype examination of lung macrophages, additional methodologies will be developed including a second mass cytometry (CyTOF) panel for single-cell proteomics and CyTOF-based phagocytosis and efferocytosis assays to allow for performance of truly single-cell functional phenotyping of myeloid cells from BAL and lung tissue (Aim 1).
- Conditions
- Copd, Smoking, Tobacco Use
- Being tested
- Bronchoscopy with Bronchoalveolar Lavage (BAL)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Smoking, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopy with Bronchoalveolar Lavage (BAL)Procedure or surgery
Also called Albuterol Administration, Peak Flow Measurement, Pulmonary Function Test (with Spirometry), Blood draw
- 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).
- Albuterol Administration: The subjects will inhale 2 puffs of respiratory medication albuterol, then repeat the breathing test.
- Peak Flow Measurement: Subjects will breathe in fully then out forcefully into the handheld device.
- 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.
- Blood draw
- Medical Health and Symptom Questionnaires
- Physical Exam by study doctor to determine suitability and safety for participation.
| Study group | Role | What they receive |
|---|---|---|
| Normal RV/TLC Group: | Plethysmographic RV/TLC equal or less than lower limit of normal. Receives: Procedure: Bronchoscopy with Bronchoalveolar Lavage (BAL) | |
| Abnormal RV/TLC Group: | Plethysmographic RV/TLC higher than lower limit of normal. Receives: Procedure: Bronchoscopy with Bronchoalveolar Lavage (BAL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of macrophage sub-populations in airway lumen.
Number of macrophages measured by flow cytometry.
Measured: 4 weeks
Functional status of macrophage sub-populations in airway lumen.
Relative percentage of macrophages measured by flow cytometry.
Measured: 4 weeks
Secondary outcomes (1)
Symptomatic responses
Evidence for presence of mild exacerbation as measured by changes at or above the level of minimally clinically important difference (MCID) in each of the questionnaire's symptom score, 1-6, for the number of flare-ups in the past 3 years, with 6 being the worst outcome.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Mehrdad Arjomandi, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722835
- Sponsor's protocol ID
- 19-29768
- Acronym
- Pre-COPD Pilot
- Status last verified
- Jun 2026
- First submitted
- 9 Dec 2020
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Macrophage Populations and Functions in Chronic Obstructive Pulmonary Disease (COPD)-Susceptible Smokers
- ClinicalTrials.gov ID
- NCT04722835
- Acronym / sponsor ID
- Pre-COPD Pilot / 19-29768
- Conditions
- Copd, Smoking, Tobacco Use
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Expiratory Volume (FEV1) / Forced Vital Capacity (FVC). Of the 20 subjects, 10 with and 10 without air trapping as determined by high and abnormal versus low and normal Residual Volume (RV) / Total Lung Capacity (TLC) measured by plethysmography. The cohort will undergo extensive clinical characterization including full Pulmonary Function Testing (PFT) and medical, symptom, activity, and quality of life questionnaires assessment including modified Medical Council Research (mMRC), COPD Assessment Test (CAT), Short Form-12 (SF12), and St. George's Respiratory (SGRQ) questionnaires. Subjects will undergo bronchoscopy with bronchoalveolar lavage (BAL) to obtain luminal macrophages and BAL fluid (BALF). Live BAL cells, BALF, and BAL cell RNA will be collected and stored in our biorepository for proposed studies. Molecular, functional, and transcriptomics analyses of luminal (alveolar) macrophages obtained by BAL (Aim 2) and protease activity measurement in serum and BALF will be performed (Aim 2) and will be examined against the clinical phenotype of the subjects, in particular air trapping-phenotype, to see if an underlying biological signature for susceptibility to develop COPD could be identified.
To perform a more comprehensive molecular and functional phenotype examination of lung macrophages, additional methodologies will be developed including a second mass cytometry (CyTOF) panel for single-cell proteomics and CyTOF-based phagocytosis and efferocytosis assays to allow for performance of truly single-cell functional phenotyping of myeloid cells from BAL and lung tissue (Aim 1).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal RV/TLC Group: | – | Procedure: Bronchoscopy with Bronchoalveolar Lavage (BAL)Plethysmographic RV/TLC equal or less than lower limit of normal. |
| Abnormal RV/TLC Group: | – | Procedure: Bronchoscopy with Bronchoalveolar Lavage (BAL)Plethysmographic RV/TLC higher than lower limit of normal. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will recruit both healthy, non-smoking subjects as well as subjects with at least 20 pack-years of smoking and air trapping.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoscopy with Bronchoalveolar Lavage (BAL)Also: Albuterol Administration, Peak Flow Measurement, Pulmonary Function Test (with Spirometry), Blood draw1. 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. | Procedure or surgery | Abnormal RV/TLC Group:, Normal RV/TLC Group: |
Primary outcome
Prevalence of macrophage sub-populations in airway lumen.
Time frame: 4 weeks
Number of macrophages measured by flow cytometry.
Functional status of macrophage sub-populations in airway lumen.
Time frame: 4 weeks
Relative percentage of macrophages measured by flow cytometry.
1 secondary outcome
Symptomatic responses
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mehrdad Arjomandi, MD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Copd and Smoking, run by University of California, San Francisco at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yorusaliem Abrham (415-221-4810 ext. 24269, yorusaliem.abrham@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of macrophage sub-populations in airway lumen. (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.