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Evaluating the Lung Microbiome in NTM Bronchiectasis

This observational study is looking at the tiny living organisms (microbiome) in the airways of people with Nontuberculous Mycobacteria (NTM) disease and bronchiectasis. Researchers want to see if specific changes in these organisms are linked to NTM disease. You might be able to join if you are 18 or older, have symptoms like cough or fatigue, and have certain imaging abnormalities. The study will evaluate your airway microbiome using samples from induced sputum (mucus coughed up from the lungs) and upper airway samples. For some participants, a bronchoscopy (a procedure where a thin tube is inserted into the airways) will also be used to collect samples. The main goal is to compare the airway microbiome in people with active NTM disease to those without it, measured at 4 hours.

Study design
This is an observational study, meaning researchers will collect information without giving any new treatments. It aims to enroll 1000 participants, with a subgroup undergoing bronchoscopy.
What's involved
You would provide induced sputum and upper airway samples. If you are in a subgroup, you would also undergo a bronchoscopy procedure.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 4 hours, which suggests a short follow-up period for this specific measurement.

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NCT02779478

Evaluation Of The Lung Microbiome In NTM Bronchiectasis

Recruiting
Not specifiedAges 18+Observational
NYU Langone Health
~1,000 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:Bronchoscopy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluation of airway microbiome in subjects with active pulmonary NTM disease and compare with controls
Measured over 4 Hours

Conditions

Nontuberculous Mycobacteria
Bronchiectasis

Explore related trials

BronchiectasisChronic Obstructive Pulmonary DiseaseNontuberculous Mycobacteria

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Leopoldo Segal, MD · PRINCIPAL_INVESTIGATOR · New York University Medical School

Who to contact

Lisa Guiterrez
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Evaluation of airway microbiome in subjects with active pulmonary NTM disease and compare with controls4 Hours

    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.