Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT02777879

Conditions

Chronic Obstuctive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Bronchoscopy

Study Details

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

Study ID

NCT02777879

Start date

May, 2014

Status verified date

Jan, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

230 participants

Anticipated

Interventions and Outcome Measures

Arms

Chronic Obstructive Pulmonary Disease (COPD)

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

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).

Interventions

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.

Primary outcome measure

  • 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 [ Time Frame: 4 Hours ]

Central Contacts and Locations

Central contacts

Rosemary Schluger

Rosemary.Schluger@nyulangone.org

Locations

New York University School of Medicine

Recruiting

New York, New York, United States, 10016

Contacts

Kathryn Norris

Kathryn.Norris@nyumc.org

Adrienne Scott

Adrienne.Scott@nyumc.org

More Information

Sponsor

NYU Langone Health

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Keywords

  • Chronic Obstructive Pulmonary Disease (COPD)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-01-28.