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
Qualifiers
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 design
Treatments tested in this trial
- Bronchoscopy
Treatment groups
1,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov