Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT04722835

Conditions

Copd

Smoking

Tobacco Use

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Bronchoscopy with Bronchoalveolar Lavage (BAL)

Study Details

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.

Conditions

Copd

Smoking

Tobacco Use

Study ID

NCT04722835

Start date

Mar 1, 2021

Status verified date

Jun, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Bronchoscopy with Bronchoalveolar Lavage (BAL)

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.

Primary outcome measure

  • Prevalence of macrophage sub-populations in airway lumen. [ Time Frame: 4 weeks ]
  • Functional status of macrophage sub-populations in airway lumen. [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Yorusaliem Abrham

415-221-4810yorusaliem.abrham@ucsf.edu

Helen Lozier, B.A.

(415) 609-6738helen.lozier@ucsf.edu

Locations

San Francisco VA Medical Center

Recruiting

San Francisco, California, United States, 94121

Contacts

Yorusaliem Abrham

415-221-4810yorusaliem.abrham@ucsf.edu

Principal Investigator:

Mehrdad Arjomandi, M.D.

More Information

Sponsor

University of California, San Francisco

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-06-04.