A Prospective, Open labeled, multi-Center, Evaluation of the Efficacy Safety and Tolerability of Nitric Oxide Given Intermittently via Inhalation to Subjects with NTM (specifically MABSC) Nitric Oxide (NO) has been shown to play a critical role in various biological functions. In the airways, NO is considered to play a key role in the innate immune system in which the first-line of host defense against microbes is built. In vitro studies suggested that NO, in part per million (ppm) concentrations, possesses anti-microbial activity against a wide variety of phyla including fungi, and antibiotic-resistance bacteria. In this study the investigators wish to evaluate the efficacy, safety and tolerability of 160 ppm Nitric Oxide intermittently delivered via inhalation to subjects infected with Non-tuberculosis mycobacteria (NTM), specifically with MABSC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Subjects will be treated with 91 thirty minute sessions of 160 ppm Nitric Oxide with at least 3 hours between each session.
Rambam Medical Center
Haifa, Israel
Safety measured by NO-related Serious Adverse Events
Time frame: 21 days
Six minute walk test
Time frame: 21 days
Mycobacterium Abscesuss load in sputum
Time frame: 81 days
NO-related AE's such as elevation of methemoglobin and elevation of NO2 during treatment
Time frame: 21 days
Type and frequency of occurrence of NO-related Adverse Events (AE's) and Serious AE's (SAE's)
Time frame: 51 days
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