Evaluation Of The Lung Microbiome In NTM Bronchiectasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
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
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Bronchoscopy
Procedure/Surgery
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Positive NTM Culture1 intervention
Group B: Negative NTM Culture1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of airway microbiome in subjects with active pulmonary NTM disease and compare with controls
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.
Time frame
4 HoursSecondary outcomes
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 Hour2
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 Hours3
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 HourSponsors and contacts
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Source ClinicalTrials.gov