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Lung Microbiome and Inflammation in Early COPD
NCT02777879 · NYU Langone Health
In plain English
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Official title
Lung Microbiome and Inflammation in Early Chronic Obstructive Pulmonary Disease (COPD)
About this study
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 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
Study design
Enrollment target: 230 participants
Age groups: adult, older_adult
Timeline
Starts: 2014-05
Estimated completion: 2030-08
Last updated: 2026-01-28
Interventions
Procedure: Bronchoscopy
Primary outcomes
- • 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)
Sponsor
NYU Langone Health · other
Contacts & investigators
ContactRosemary Schluger · contact · Rosemary.Schluger@nyulangone.org
InvestigatorLeopoldo Segal, MD · principal_investigator, New York University Medical School
All locations (1)
New York University School of MedicineRecruiting
New York, New York, United States