Lung macrophage patterns in COPD-susceptible smokers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational pilot study enrolling 20 adults aged 40–75 with a significant smoking history but no COPD or asthma and no airflow obstruction. Participants will be stratified by air trapping (RV/TLC) and undergo bronchoscopy with bronchoalveolar lavage to collect lung macrophages and BAL fluid, plus comprehensive clinical and quality-of-life assessments. Molecular, functional, and transcriptomic analyses of alveolar macrophages, along with protease activity measurements, will be correlated with an air-trapping phenotype to identify potential biological signatures of susceptibility to COPD. Findings will inform the design of a larger future study exploring mechanisms of COPD development in smokers.

Why it matters

Who can join: the full rules

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.

Where it's running

• San Francisco VA Medical Center
  San Francisco, California, United States Recruiting
• Zuckerberg San Francisco General Hospital and Trauma Center
  San Francisco, California, United States Active not recruiting
• University of California, San Francisco
  San Francisco, California, United States Active not recruiting

Study contacts

• Principal investigator: Mehrdad Arjomandi, MD — University of California, San Francisco
• Study coordinator: Yorusaliem Abrham
• Email: yorusaliem.abrham@ucsf.edu
• Phone: 415-221-4810

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Abuse potential of five modern oral nicotine products

  This will test how five modern oral nicotine products compare with cigarettes and nicotine gum in how satisfying they feel and how much nicotine adult smokers absorb.

  Recruiting RAI Services Company · Overland Park, Kansas · NCT07132814

• Using an air quality monitor to encourage smoke-free homes for cancer patients

  This study is testing if using an air quality monitor can help cancer patients who smoke create smoke-free homes and quit smoking.

  Recruiting at 7 sites Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 7 other locations · NCT06693700

• Comparing mobile health screening to traditional methods for early detection of oral cancer in rural Varanasi.

  This study tests if using mobile health screenings can help find oral cancer earlier than traditional methods for people living in rural Varanasi.

  Recruiting Memorial Sloan Kettering Cancer Center · New York, New York · NCT06535867

• Evaluating how flavor affects smokers switching to e-cigarettes

  This study tests whether different e-cigarette flavors can help smokers switch from regular cigarettes to e-cigarettes more easily.

  Recruiting Abramson Cancer Center at Penn Medicine · Philadelphia, Pennsylvania · NCT06264154

• Understanding brain activity related to smoking lapses

  This study is trying to see how brain activity changes in adults who smoke right before they might slip up and have a cigarette after trying to quit.

  Recruiting Penn State University · University Park, Pennsylvania · NCT05572671

• Salivary IL-8 and Serum IL-6 as Biomarkers to Distinguish Oral Premalignant Disorders in Smokers and Never-Smokers

  This study tests whether salivary IL-8 and blood IL-6 can help tell apart adults with oral premalignant conditions from those with healthy mouths, and whether smoking influences these markers.

  Recruiting British University In Egypt · Cairo · NCT07915570

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.