Lung Microbiome and Inflammation in Early COPD

NCT02777879 | Recruiting

• 1 other identifier: 14-01546
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstuctive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bacterial metabolic pathways in the lower airways using metagenomic and metabolomic approaches

  4 Hours

Study Arms (2)

Chronic Obstructive Pulmonary Disease (COPD)

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

Procedure: Bronchoscopy

Control

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).

Procedure: Bronchoscopy

Interventions

Bronchoscopy PROCEDURE

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.

Chronic Obstructive Pulmonary Disease (COPD); Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Utilizing cohorts built at NYU over the last several years, this project is uniquely positioned to investigate the microbiome signatures among subjects with COPD.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Microbial DNA will be extracted from sputum and BAL fluid. Variable 16S rRNA gene regions will be amplified by PCR using bar-coded primers flanking a portion of marker gene. PCR products will be sequenced in the NYU Genome Technology Center using MiSeq platform (Illumina).

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Leopoldo Segal, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosemary Schluger

CONTACT

Rosemary.Schluger@nyulangone.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 19, 2016
• Study Start: May 1, 2014
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (1)