Lung Microbiome and Inflammation in Early COPD

Chronic Obstuctive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02777879
• Other study ID #: 14-01546
• Status: Recruiting
• Start date: May 2014
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: Rosemary Schluger
• Email: Rosemary.Schluger[@]nyulangone.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstuctive Pulmonary Disease
• Inflammation
• Lung Diseases

Intervention

Procedure:
• Bronchoscopy
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

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bacterial metabolic pathways in the lower airways using metagenomic and metabolomic approaches	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.	4 Hours