Inhaled Nitric Oxide for Patients With MABSC
Study Details
Study Description
Brief Summary
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 |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Nitric Oxide treatment
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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.
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Outcome Measures
Primary Outcome Measures
- Safety measured by NO-related Serious Adverse Events [21 days]
Secondary Outcome Measures
- Six minute walk test [21 days]
- Mycobacterium Abscesuss load in sputum [81 days]
- NO-related AE's such as elevation of methemoglobin and elevation of NO2 during treatment [21 days]
- Type and frequency of occurrence of NO-related Adverse Events (AE's) and Serious AE's (SAE's) [51 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects (Male or female) between 6 to 65 years old
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Diagnosis of pulmonary non-tuberculosis mycobacterial lung disease in accordance with the 2007 ATS/IDSA criteria with evidence of nodular bronchiectasis and/or cavitary disease by chest computed tomography (CT) and by culture.
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History of at least 6 months chronic infection with Mycobacterium abscessus.
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Mycobacterium abscessus positive sputum sample at screening or prior to screening.
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Receiving ATS/IDSA guidelines-based treatment regimen defined as: adherent to a multi-drug regimen for at least 6 months prior to screening with persistently positive mycobacterial abscessus cultures.
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FEV1 ≥ 30% at screening as well as baseline.
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Ability to produce sputum or be willing to undergo an induction of sputum for clinical evaluation.
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Life expectancy ≥1 year
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Ability to perform 6MWT, but not to exceed a distance of 700 meters during screening.
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Ability to understand and comply with study requirements.
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Approved and signed informed consent by subject and/or by parent/legal guardian (depending on subject's age).
Exclusion Criteria:
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Breastfeeding or pregnancy as evidenced by a positive pregnancy test.
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Subjects diagnosed with methemoglobinemia, immunodeficiency, heart disease, pulmonary hypertension and/or high blood pressure.
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Use of an investigational drug during the last 30 days prior enrollment and/or the subject is expected to participate in a new study within five months from enrollment to this study.
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History of frequent epistaxis (>1 episode/month).
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Significant hemoptysis during the last 30 days prior to enrolment (>30 Ml of blood in a 24-hour period).
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Methemoglobin level >2% at screening.
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Patients on inconsistant dosage of systemic steroids (any formulation) 30 days prior to enrolment.
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History of illicit drug or medication abuse within 1 year of screening.
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History of lung transplantation.
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History of daily, continuous oxygen supplementation.
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Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
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Pulmonary tuberculosis requiring treatment or treated within 2 years prior to screening.
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Any change in chronic NTM multi-drug regimen within 28 days prior to study day 1.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Rambam Medical Center | Haifa | Israel |
Sponsors and Collaborators
- Beyond Air Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AIT_ CP_ CFNTM_01