Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT02779478

Conditions

Nontuberculous Mycobacteria

Bronchiectasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bronchoscopy

Study Details

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

Nontuberculous Mycobacteria

Bronchiectasis

Study ID

NCT02779478

Start date

Oct 1, 2014

Status verified date

Feb, 2026

Completion date

Jul, 2031

Anticipated

Primary completion date

Jul, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

Interventions

Bronchoscopy

Primary outcome measure

  • Evaluation of airway microbiome in subjects with active pulmonary NTM disease and compare with controls [ Time Frame: 4 Hours ]

Central Contacts and Locations

Central contacts

Lisa Guiterrez

Lira.Gutierrez@nyulangone.org

Rosemary Schluger

Rosemary.Schluger@nyulangone.org

Locations

New York University School of Medicine

Recruiting

New York, New York, United States, 10016

Contacts

Maria Tarallo, MD

taralm01@nyumc.org

Adrienne Scott

scotta06@nyumc.org

Principal Investigator:

Leopoldo Segal, MD

More Information

Sponsor

NYU Langone Health

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-02-27.