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RECRUITINGOBSERVATIONAL

Lung Microbiome and Inflammation in Early COPD

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 willing to sign a consent form. - Antibiotic use within the prior 2months Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

PROCEDURE

Bronchoscopy

Flexible bronchoscopy with bronchoalveolar lavage (BAL) and bronchial brushings will be done in a standardized manner. The bronchoscope tip is sequentially wedged in sub-segments where BAL will be performed on a total of two segments of the lung (120 ml in each segment for a total of 360 ml). Two brushes will be done under direct visualization in both segments. Selection of segments to sample will be based on where abnormalities are in imaging.

Locations (1)

New York University School of Medicine
New York, New York, United States