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NCT Number: NCT02777879

Lung Microbiome and Inflammation in Early COPD

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

New York University School of Medicine

New York, 10016, United States

Location status: Recruiting

Location contact

Adrienne Scott

CONTACT

[email protected]

Ashwin Basavaraj, MD

SUB_INVESTIGATOR

Doreen J Addrizzo-Harris, MD

SUB_INVESTIGATOR

Kathryn Norris

CONTACT

[email protected]

Michael D Weiden, MD

SUB_INVESTIGATOR

Rany Condos, MD

SUB_INVESTIGATOR

Stephanie Lau, MD

SUB_INVESTIGATOR

Yonghua Li, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

    Time frame: 4 Hours

Secondary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rosemary Schluger

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2030
Study completion
2030
First posted
May 19, 2016
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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