## Protocol Section
### Identification Module
**NCT ID:** NCT02777879

**Brief Title:** Lung Microbiome and Inflammation in Early COPD

**Official Title:** Lung Microbiome and Inflammation in Early Chronic Obstructive Pulmonary Disease (COPD)

#### Organization Study ID Info
**ID:** 14-01546
#### Organization
**Class:** OTHER
**Full Name:** NYU Langone Health
### Status Module
#### Completion Date
**Date:** 2026-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-29

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2014-05

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2016-05-19
**Type:** ESTIMATED
**Study First Submit Date:** 2016-05-17
**Study First Submit QC Date:** 2016-05-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** NYU Langone Health

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Chronic Obstuctive Pulmonary Disease

**Keywords:**

- Chronic Obstructive Pulmonary Disease (COPD)

### Design Module

#### Bio Spec

**Description:** 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).

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 230

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: Bronchoscopy

**Label:** Chronic Obstructive Pulmonary Disease (COPD)

#### Arm Group 2

**Description:** 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).

**Intervention Names:**

- Procedure: Bronchoscopy

**Label:** Control

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Chronic Obstructive Pulmonary Disease (COPD)

- Control

**Description:** 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.

**Name:** Bronchoscopy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**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

#### Secondary Outcomes

**Description:** 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.

**Measure:** Bacterial metabolic pathways in the lower airways using metagenomic and metabolomic approaches

**Time Frame:** 4 Hours

### Eligibility Module

**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

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Rosemary.Schluger@nyulangone.org

**Name:** Rosemary Schluger

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Email:** Kathryn.Norris@nyumc.org

- **Name:** Kathryn Norris

- **Role:** CONTACT

***Contact 2:***

- **Email:** Adrienne.Scott@nyumc.org

- **Name:** Adrienne Scott

- **Role:** CONTACT

***Contact 3:***

- **Name:** Doreen J Addrizzo-Harris, MD

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Rany Condos, MD

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Stephanie Lau, MD

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** Ashwin Basavaraj, MD

- **Role:** SUB_INVESTIGATOR

***Contact 7:***

- **Name:** Michael D Weiden, MD

- **Role:** SUB_INVESTIGATOR

***Contact 8:***

- **Name:** Yonghua Li, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** New York University School of Medicine

**State:** New York

**Status:** RECRUITING

**Zip:** 10016

#### Overall Officials

**Official 1:**

**Affiliation:** New York University Medical School

**Name:** Leopoldo Segal, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: HIGH

- As Found: Inflammation

- ID: M11168

- Name: Lung Diseases

- Relevance: HIGH

- As Found: Pulmonary Disease

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M23449

- Name: Pulmonary Disease, Chronic Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008171

- Term: Lung Diseases

- ID: D000007249

- Term: Inflammation

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M7296

- Name: Dimercaprol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
