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Lung Macrophage Populations and Functions in Chronic Obstructive Pulmonary Disease (COPD)-Susceptible Smokers

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 75 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study will develop research methods and gather early data on why some people who smoke get COPD, a long-term lung disease. It is for adults ages 40 to 75 without COPD or asthma, but the listed smoking rules conflict and need to be checked with the study team.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 40 to 75 years old.
  • One rule requires at least 20 pack-years of smoking. This means, for example, smoking 1 pack a day for 20 years.
  • Another rule requires less than 1 pack-year of smoking and no tobacco use in the past 12 months. Ask the study team which smoking rule applies to you.
  • You have not been diagnosed with COPD or asthma.
  • A breathing test shows no blocked airflow, with an FEV1/FVC ratio of at least 0.7.
  • Two breathing test results, FEV1 and FVC, must be above the lowest normal level. These measure how much air you can blow out.
  • You will be placed in one of two groups based on RV/TLC, the share of air left in your lungs after breathing out. The groups are at or below the lowest normal level, or above it.

Who can't join

  • You have injected drugs or breathed in recreational drugs other than marijuana within the past 20 years, injected drugs more than 100 times, or used these drugs for longer than 1 year.
  • You have smoked more than 400 marijuana joints in your life or used marijuana within the past 6 months.
  • You cannot walk fast, run on a treadmill, or pedal an exercise machine at the level needed for the study.
  • You are pregnant or breastfeeding.
  • You have a serious, active heart condition: chest pain from low blood flow, a heart attack within the past 2 years, heart failure, or a weakened heart from poor blood flow.
  • You have cirrhosis, which is severe liver scarring.
  • You have a history of long-term, active hepatitis B or C, infections that affect the liver.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (3)

CA