RightFit
RecruitingPhase not listed

Lung Microbiome and Inflammation in Early COPD

Lung Microbiome and Inflammation in Early Chronic Obstructive Pulmonary Disease (COPD)

Who can join

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

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not 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

Not stated in the study description — ask the study team about visits and procedures.

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 looks at bacteria in the lungs and inflammation, or swelling, in smokers with and without early COPD. COPD is a lung disease that makes breathing harder. Researchers will study how lung bacteria work and how the body's defenses respond.

This is a cross sectional case controlled study to assess lung microbiome and inflammation in smokers with and without Chronic Obstructive Pulmonary Disease (COPD). Investigators will look at active bacterial metabolic pathways in the lower airways using metagenomic and metabolomic approaches an assess relationships among microbiome, metagenome, metabolome and host immune responses in COPD and controls. Investigators believe COPD cases will have higher prevalence of pneumotype supraglottic predominant taxa (SPT) than matched controls.

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

Eligibility

Who can join

  • For the COPD group: Smokers with early COPD and more than 20 pack-years of smoking (such as 1 pack a day for 20 years). Breathing tests must show an FEV1/FVC ratio below 70% and FEV1 above 50% of the expected value.
  • For the comparison group: Smokers with normal results on spirometry, a test of how well you breathe.

Who can't join

  • FEV1 below 50% of the expected value. FEV1 measures how much air you can blow out in 1 second.
  • Major heart or blood vessel disease, including an abnormal heart electrical test, known or suspected disease in the heart's arteries, or heart failure.
  • Diabetes, or major liver or kidney disease.
  • A severe blood-clotting problem: INR above 1.4, PTT above 40 seconds, and a platelet count below 150,000. These tests measure clotting and cells that help stop bleeding.
  • Pregnancy.
  • Drinking more than 6 beers or more than 4 mixed drinks each day.
  • Unable to understand the study and give informed consent.
  • Antibiotic use in the past 2 months.

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

Official eligibility criteria

Inclusion Criteria: * Case definition: Smokers (\>20 pack-year) with airflow obstruction (FEV1/FVC\<70) and FEV1\>50% predicted (early COPD GOLD 1 or 2) * Control definition: Smokers with normal spirometry will serve as controls. Exclusion Criteria: * FEV1 \< 50% NOT 70 * Significant cardiovascular disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure. * Diabetes mellitus * Significant liver or renal disease * Severe coagulopathy (INR \> 1.4, PTT \> 40 seconds and platelet count \< 150x103 cells). * Pregnancy * ETOH use of more than \>6 beers or \>4 mixed drinks daily * Lack of capacity to provide informed consent. * Antibiotic use within the prior 2months

Study sites (1)

NY