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Evaluation Of The Lung Microbiome In NTM Bronchiectasis

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ClinicalTrials.gov Identifier: NCT02779478
Recruitment Status : Recruiting
First Posted : May 20, 2016
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment
Nontuberculous Mycobacteria Bronchiectasis Procedure: Bronchoscopy

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation Of The Lung Microbiome In NTM Bronchiectasis
Study Start Date : April 2016
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Group/Cohort Intervention/treatment
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
Procedure: Bronchoscopy
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.
Procedure: Bronchoscopy



Primary Outcome Measures :
  1. Evaluation of airway microbiome in subjects with active pulmonary NTM disease and compare with controls [ Time Frame: 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 :
  1. 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 [ Time Frame: 1 Hour ]
  2. Laryngoscopy to calculate the Reflux finding score (RFS, a validated quantitative measurement of impact of laryngopharyngeal reflux on the upper airway in adults [ Time Frame: 4 Hours ]
  3. Reflux Symptom Index evaluate the prevalence of laryngopharyngeal reflux and dysphagia/aspiration in subjects with active pulmonary NTM disease compared with controls [ Time Frame: 1 Hour ]

Biospecimen Retention:   Samples With DNA
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, 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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779478


Contacts
Contact: Maria Tarallo taralm01@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Maria Tarallo, MD       taralm01@nyumc.org   
Contact: Adrienne Scott       scotta06@nyumc.org   
Principal Investigator: Leopoldo Segal, MD         
Sub-Investigator: Stephanie Lau, MD         
Sub-Investigator: Milan Amin, MD         
Sub-Investigator: David Kamelhar, MD         
Sub-Investigator: Doreen Addrizzo-Harris, MD         
Sub-Investigator: Katrina Bantis, MD         
Sub-Investigator: Benjamin Wu, MD         
Sub-Investigator: Ashwin Basavaraj, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Leopoldo Segal, MD New York University Medical School

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02779478     History of Changes
Other Study ID Numbers: 14-01400
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:
chronic obstructive pulmonary disease (COPD)
cavitary
nodular bronchiectatic disease
NTM

Additional relevant MeSH terms:
Bronchiectasis
Mycobacterium Infections
Bronchial Diseases
Respiratory Tract Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections