Bronchiectasis, Nontuberculous Mycobacteria
Conditions
Keywords
chronic obstructive pulmonary disease (COPD), cavitary, nodular bronchiectatic disease, NTM
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.
Interventions
PROCEDUREBronchoscopy
Sponsors
NYU Langone Health
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Reflux Symptom Index evaluate the prevalence of laryngopharyngeal reflux and dysphagia/aspiration in subjects with active pulmonary NTM disease compared with controls | 1 Hour |
Countries
United States
Contacts
CONTACTLisa Guiterrez
CONTACTRosemary Schluger
PRINCIPAL_INVESTIGATORLeopoldo Segal, MD
New York University Medical School
Outcome results
None listed