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RecruitingNCT02777879

Lung Microbiome and Inflammation in Early COPD

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

Sponsor

NYU Langone Health

Enrollment

230 participants

Start Date

May 1, 2014

Study Type

OBSERVATIONAL

Conditions

Chronic Obstuctive Pulmonary Disease

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria2

  • 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 Criteria9

  • 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

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Interventions

PROCEDUREBronchoscopy

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

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NCT02777879