Inhaled Nitric Oxide for Patients With MABSC
- Registration Number
- NCT03208764
- Lead Sponsor
- Beyond Air Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- Subjects (Male or female) between 6 to 65 years old
- 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.
- History of at least 6 months chronic infection with Mycobacterium abscessus.
- Mycobacterium abscessus positive sputum sample at screening or prior to screening.
- 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.
- FEV1 ≥ 30% at screening as well as baseline.
- Ability to produce sputum or be willing to undergo an induction of sputum for clinical evaluation.
- Life expectancy ≥1 year
- Ability to perform 6MWT, but not to exceed a distance of 700 meters during screening.
- Ability to understand and comply with study requirements.
- Approved and signed informed consent by subject and/or by parent/legal guardian (depending on subject's age).
- Breastfeeding or pregnancy as evidenced by a positive pregnancy test.
- Subjects diagnosed with methemoglobinemia, immunodeficiency, heart disease, pulmonary hypertension and/or high blood pressure.
- 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.
- History of frequent epistaxis (>1 episode/month).
- Significant hemoptysis during the last 30 days prior to enrolment (>30 Ml of blood in a 24-hour period).
- Methemoglobin level >2% at screening.
- Patients on inconsistant dosage of systemic steroids (any formulation) 30 days prior to enrolment.
- History of illicit drug or medication abuse within 1 year of screening.
- History of lung transplantation.
- History of daily, continuous oxygen supplementation.
- 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.
- Pulmonary tuberculosis requiring treatment or treated within 2 years prior to screening.
- Any change in chronic NTM multi-drug regimen within 28 days prior to study day 1.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nitric Oxide treatment Nitric Oxide -
- Primary Outcome Measures
Name Time Method Safety measured by NO-related Serious Adverse Events 21 days
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Rambam Medical Center
🇮🇱Haifa, Israel