Evaluation Of The Lung Microbiome In NTM Bronchiectasis

Recruiting

• Conditions: Nontuberculous Mycobacteria; Bronchiectasis
• Interventions: Procedure: Bronchoscopy

• Registration Number: NCT02779478
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-01
• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26
• Primary Completion: 2030-07
• Study Completion: 2031-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 455

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Negative NTM Culture	Bronchoscopy	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.
Positive NTM Culture	Bronchoscopy	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

Primary Outcome Measures

Name	Time	Method
Evaluation of airway microbiome in subjects with active pulmonary NTM disease and compare with controls	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 Outcome Measures

Name	Time	Method
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	1 Hour
Reflux Symptom Index evaluate the prevalence of laryngopharyngeal reflux and dysphagia/aspiration in subjects with active pulmonary NTM disease compared with controls	1 Hour
Laryngoscopy to calculate the Reflux finding score (RFS, a validated quantitative measurement of impact of laryngopharyngeal reflux on the upper airway in adults	4 Hours

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States