Examining lung bacteria and inflammation in early COPD patients
Lung Microbiome and Inflammation in Early Chronic Obstructive Pulmonary Disease (COPD)
This study is trying to see how the bacteria in the lungs and inflammation levels differ between smokers with and without early COPD.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 230 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT02777879 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the lung microbiome and inflammation in smokers with and without Chronic Obstructive Pulmonary Disease (COPD). It employs a cross-sectional case-controlled design to analyze active bacterial metabolic pathways in the lower airways using metagenomic and metabolomic techniques. The study aims to identify differences in microbiome composition and immune responses between COPD patients and matched controls. Researchers hypothesize that COPD cases will show a higher prevalence of specific bacterial taxa compared to controls.
Who should consider this trial
Good fit: Ideal candidates include smokers with a history of more than 20 pack-years who exhibit early-stage COPD with airflow obstruction.
Not a fit: Patients with severe COPD, significant cardiovascular or metabolic diseases, or those currently using antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the role of the lung microbiome in COPD, potentially leading to new therapeutic strategies.
How similar studies have performed: While studies on the lung microbiome are emerging, this specific approach focusing on early COPD is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- New York University School of Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Leopoldo Segal, MD — New York University Medical School
- Study coordinator: Rosemary Schluger
- Email: Rosemary.Schluger@nyulangone.org
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.