Clinical trial NCT02779478: Evaluation Of The Lung Microbiome In NTM Bronchiectasis
Official title: Evaluation Of The Lung Microbiome In NTM Bronchiectasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nontuberculous Mycobacteria
Bronchiectasis
Keywords: chronic obstructive pulmonary disease (COPD)
cavitary
nodular bronchiectatic disease
NTM
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of airway microbiome in subjects with active pulmonary NTM disease and compare with controls
timeFrame: 4 Hours
Secondary outcomes:
measure: 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
timeFrame: 1 Hour
measure: Laryngoscopy to calculate the Reflux finding score (RFS, a validated quantitative measurement of impact of laryngopharyngeal reflux on the upper airway in adults
timeFrame: 4 Hours
measure: Reflux Symptom Index evaluate the prevalence of laryngopharyngeal reflux and dysphagia/aspiration in subjects with active pulmonary NTM disease compared with controls
timeFrame: 1 Hour
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Leopoldo Segal, MD
role: PRINCIPAL_INVESTIGATOR
References: