Inhaled Nitric Oxide for Patients With MABSC
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|ClinicalTrials.gov Identifier: NCT03208764|
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : February 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Mycobacterium Abscessus Infection||Drug: Nitric Oxide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||July 24, 2017|
|Actual Primary Completion Date :||December 15, 2017|
|Estimated Study Completion Date :||April 15, 2018|
|Experimental: Nitric Oxide treatment||
Drug: Nitric Oxide
Subjects will be treated with 91 thirty minute sessions of 160 ppm Nitric Oxide with at least 3 hours between each session.
- 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 ]
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): NCT03208764
|Contact: Rinat Kalaora, M. Sc||+972-544750887||Rinatk@ait-pharm.com|
|Contact: Mark Mizrahi, Ph.D||+972-524502245||Marko@ait-pharm.com|
|Rambam Medical Center||Recruiting|