RecruitingNCT02779478

Evaluation Of The Lung Microbiome In NTM Bronchiectasis

Sponsor

NYU Langone Health

Enrollment

1,000 participants

Start Date

Oct 1, 2014

Study Type

OBSERVATIONAL

Conditions

Bronchiectasis Nontuberculous Mycobacteria

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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:

Exclusion Criteria10

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.