Inhaled Nitric Oxide for Patients With MABSC

• ClinicalTrials.gov Identifier: NCT03208764
• Recruitment Status: Completed
• First Posted: July 6, 2017
• Last Update Posted: July 9, 2019
• Sponsor: Beyond Air Inc.
• Information provided by (Responsible Party): Beyond Air Inc.

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
Mycobacterium Abscessus Infection	Drug: Nitric Oxide	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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: May 1, 2018
• Actual Study Completion Date: April 11, 2019

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Safety measured by NO-related Serious Adverse Events [ Time Frame: 21 days ]

Secondary Outcome Measures :

1. Six minute walk test [ Time Frame: 21 days ]
2. Mycobacterium Abscesuss load in sputum [ Time Frame: 81 days ]
3. NO-related AE's such as elevation of methemoglobin and elevation of NO2 during treatment [ Time Frame: 21 days ]
4. Type and frequency of occurrence of NO-related Adverse Events (AE's) and Serious AE's (SAE's) [ Time Frame: 51 days ]

Eligibility Criteria

• Ages Eligible for Study: 6 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Subjects (Male or female) between 6 to 65 years old
2. 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.
3. History of at least 6 months chronic infection with Mycobacterium abscessus.
4. Mycobacterium abscessus positive sputum sample at screening or prior to screening.
5. 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.
6. FEV1 ≥ 30% at screening as well as baseline.
7. Ability to produce sputum or be willing to undergo an induction of sputum for clinical evaluation.
8. Life expectancy ≥1 year
9. Ability to perform 6MWT, but not to exceed a distance of 700 meters during screening.
10. Ability to understand and comply with study requirements.
11. Approved and signed informed consent by subject and/or by parent/legal guardian (depending on subject's age).

Exclusion Criteria:

1. Breastfeeding or pregnancy as evidenced by a positive pregnancy test.
2. Subjects diagnosed with methemoglobinemia, immunodeficiency, heart disease, pulmonary hypertension and/or high blood pressure.
3. 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.
4. History of frequent epistaxis (>1 episode/month).
5. Significant hemoptysis during the last 30 days prior to enrolment (>30 Ml of blood in a 24-hour period).
6. Methemoglobin level >2% at screening.
7. Patients on inconsistant dosage of systemic steroids (any formulation) 30 days prior to enrolment.
8. History of illicit drug or medication abuse within 1 year of screening.
9. History of lung transplantation.
10. History of daily, continuous oxygen supplementation.
11. 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.
12. Pulmonary tuberculosis requiring treatment or treated within 2 years prior to screening.
13. Any change in chronic NTM multi-drug regimen within 28 days prior to study day 1.

Contacts and Locations

Locations

Israel

Rambam Medical Center

Haifa, Israel

Sponsors and Collaborators

Beyond Air Inc.

More Information

• Responsible Party: Beyond Air Inc.
• ClinicalTrials.gov Identifier: NCT03208764
• Other Study ID Numbers: AIT_ CP_ CFNTM_01
• First Posted: July 6, 2017
• Last Update Posted: July 9, 2019
• Last Verified: July 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Nitric Oxide; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Free Radical Scavengers; Antioxidants; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Endothelium-Dependent Relaxing Factors; Vasodilator Agents; Gasotransmitters; Protective Agents