Lung Microbiome and Inflammation in Early COPD

Recruiting

• Conditions: Chronic Obstuctive Pulmonary Disease
• Interventions: Procedure: Bronchoscopy

• Registration Number: NCT02777879
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-04-30
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 230

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Bronchoscopy	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).
Chronic Obstructive Pulmonary Disease (COPD)	Bronchoscopy	Case of early COPD (GOLD 1-2, FEV1/FVC\<70 and FEV1\>50%)

Primary Outcome Measures

Name	Time	Method
Site specific microbiome (supraglotic area) constituents using background subtraction and source tracking approaches via a multivariable conditional logistic regression model. following broncho-alveolar lavage, BAL	4 Hours

Secondary Outcome Measures

Name	Time	Method
Bacterial metabolic pathways in the lower airways using metagenomic and metabolomic approaches	4 Hours	Bioinformatic methods such as Procrustes will be used to integrate the analysis of the generated multi-omic datasets through this study to attain a more accurately defined COPD phenotype. By elucidating the interplay between bacterial composition, microbiome functional repertoire, metabolism, and immunological status in the human lung, we will obtain further insights for hypothesis generation into the pathophysiological mechanisms underlying COPD.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States