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NCT02777879 | RECRUITING | Chronic Obstuctive Pulmonary Disease


Lung Microbiome and Inflammation in Early COPD
Sponsor:

NYU Langone Health

Brief Summary:

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.

Condition or disease

Chronic Obstuctive Pulmonary Disease

Intervention/treatment

Bronchoscopy

Study Type : OBSERVATIONAL
Estimated Enrollment : 230 participants
Official Title : Lung Microbiome and Inflammation in Early Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date : 2014-05
Estimated Primary Completion Date : 2030-08
Estimated Study Completion Date : 2030-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

Lung Microbiome and Inflammation in Early COPD

Location Details

NCT02777879


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Locations


RECRUITING

United States, New York

New York University School of Medicine

New York, New York, United States, 10016

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