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NCT Number: NCT02779478

Evaluation Of The Lung Microbiome In NTM Bronchiectasis

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.

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Key information

Age range

18 year and older

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

Benjamin Wu, MD

SUB_INVESTIGATOR

David Kamelhar, MD

SUB_INVESTIGATOR

Doreen Addrizzo-Harris, MD

SUB_INVESTIGATOR

Katrina Bantis, MD

SUB_INVESTIGATOR

Leopoldo Segal, MD

PRINCIPAL_INVESTIGATOR

Maria Tarallo, MD

CONTACT

[email protected]

Milan Amin, MD

SUB_INVESTIGATOR

Stephanie Lau, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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:

  • 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

Definition of NTM control:

  • 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.

Exclusion criteria

for cohort study (Aim 1-2):

  • Recent (<1 months prior) oral antibiotic or steroid use. (Continuous treatment with macrolides and inhaled steroids are acceptable >1 month prior)
  • Recent smoking history

Exclusion criteria

for bronchoscopic study (Aims 3-4):

  • 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.

Treatment and study plan

Bronchoscopy

Procedure

Primary outcomes

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

    Time frame: 4 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.

Secondary outcomes

  1. 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

    Time frame: 1 Hour

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

    Time frame: 4 Hours

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

    Time frame: 1 Hour

Study contacts

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

Lisa Guiterrez

CONTACT

[email protected]

Rosemary Schluger

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2014
Primary completion
2030
Study completion
2031
First posted
May 20, 2016
Registry last updated
Feb 27, 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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