Lung Microbiome and Inflammation in Early COPD

NYU Langone Health

Status: Enrolling

Conditions: Chronic Obstuctive Pulmonary Disease

Treatments: Procedure: Bronchoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT02777879

14-01546

Details and patient eligibility

About

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.

Enrollment: 230 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

230 participants in 2 patient groups

Chronic Obstructive Pulmonary Disease (COPD)

Description:

Case of early COPD (GOLD 1-2, FEV1/FVC\<70 and FEV1\>50%)

Treatment:

Procedure: Bronchoscopy

Control

Description:

No obstruction (FEV1/FVC\<70). Controls will be recruited after each case and will be matched by: age (±5 year), 2) gender, 3) smoking (±5 pack-year) and 4) BMI (±5).

Treatment:

Procedure: Bronchoscopy