Evaluation Of The Lung Microbiome In NTM Bronchiectasis

NCT02779478 | Recruiting DMC

• 1 other identifier: 14-01400
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

A biomarker cohort study design is proposed to study whether specific airway microbiota alterations are associated with pulmonary Non-tuberculous mycobacteria (NTM) disease. In a cohort of 200 subjects suspected of having pulmonary NTM disease, the investigators will evaluate the airway microbiome using an aliquot of the induced sputum and upper airway samples. Since induced sputum may reflect different regions of the upper/lower airways, the investigators will evaluate the upper and lower airway microbiome in a subgroup (case-control group) of patients using samples obtained through upper airway sampling and bronchoscopy, respectively.

Conditions

Bronchiectasis; Nontuberculous Mycobacteria

Keywords

chronic obstructive pulmonary disease (COPD); cavitary; nodular bronchiectatic disease; NTM

Outcome Measures

Primary Outcomes (1)

• Evaluation of airway microbiome in subjects with active pulmonary NTM disease and compare with controls

  Investigators will use sputum samples and brushed samples from areas of the upper airway from a cohort of 200 subjects with chronic cough and pulmonary infiltrates or airway abnormalities in whom NTM disease was suspected. Cultures positive for NTM (cases) will be compared to those with culture negatives (controls). Bacterial load by quantitative polymerase chain reaction (qPCR) will be used to characterize microbiome by high throughput sequencing looking for microbial biomarkers associated with NTM disease.

  4 Hours

Secondary Outcomes (3)

• Eating Assessment Tool (EAT-10) to evaluate the prevalence of laryngopharyngeal reflux and dysphagia/aspiration in subjects with active pulmonary NTM disease compared with controls

  1 Hour

• Laryngoscopy to calculate the Reflux finding score (RFS, a validated quantitative measurement of impact of laryngopharyngeal reflux on the upper airway in adults

  4 Hours

• Reflux Symptom Index evaluate the prevalence of laryngopharyngeal reflux and dysphagia/aspiration in subjects with active pulmonary NTM disease compared with controls

  1 Hour

Study Arms (2)

Positive NTM Culture

Subjects that meet inclusion criteria and have culture positivity for NTM: at least two separate expectorated induced sputum samples or from one bronchoalveolar lavage (BAL) or lung biopsy

Procedure: Bronchoscopy

Negative NTM Culture

Subjects that meet inclusion criteria and have less than two separate expectorated induced sputum samples culture negative or culture negative bronchoalveolar lavage (BAL) or lung biopsy.

Procedure: Bronchoscopy

Interventions

Bronchoscopy PROCEDURE

Negative NTM Culture; Positive NTM Culture

Eligibility Criteria

• Age: 18 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 NTM disease.

You may qualify if:

• History of pulmonary symptoms: cough, fatigue, malaise, fever, weight loss, dyspnea, hemoptysis, or chest discomfort
• Imaging abnormalities (within 2 years): defined as nodular or cavitary opacities on chest radiograph, or a computed tomography scan that shows bronchiectasis or bronchial wall thickening with associated multiple small nodules.
• Definition of NTM case:
• Definition of NTM control:

You may not qualify if:

• Recent (\<1 months prior) oral antibiotic or steroid use. (Continuous treatment with macrolides and inhaled steroids are acceptable \>1 month prior)
• Recent smoking history
• Forced expiratory volume at one second (FEV1) \< 70%of predicted.
• 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, Partial Thromboplastin Time (PTT) \> 40 seconds and platelet count \< 150x103 cells).
• Pregnancy
• Ethanol (ETOH) use of more than \>6 beers or \>4 mixed drinks daily
• Lack of capacity to provide informed consent.

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

Airway microbiome using an aliquot of the induced sputum and upper airway samples. Since induced sputum may reflect different regions of the upper/lower airways, investigators will evaluate the upper and lower airway microbiome in a subgroup (case-control group) of patients using samples obtained through upper airway sampling and bronchoscopy, respectively.

MeSH Terms

Conditions

Bronchiectasis; Pulmonary Disease, Chronic Obstructive

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung 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

Lisa Guiterrez

CONTACT

Lira.Gutierrez@nyulangone.org

Rosemary Schluger

CONTACT

Rosemary.Schluger@nyulangone.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 20, 2016
• Study Start: October 1, 2014
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2031
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)