Back to resultsInhaled Nitric Oxide for Patients With MABSC
Primary Purpose
Mycobacterium Abscessus Infection
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Nitric Oxide
Sponsored by
About this trial
This is an interventional treatment trial for Mycobacterium Abscessus Infection
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Sites / Locations
- Rambam Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nitric Oxide treatment
Arm Description
Outcomes
Primary Outcome Measures
Safety measured by NO-related Serious Adverse Events
Secondary Outcome Measures
Six minute walk test
Mycobacterium Abscesuss load in sputum
NO-related AE's such as elevation of methemoglobin and elevation of NO2 during treatment
Type and frequency of occurrence of NO-related Adverse Events (AE's) and Serious AE's (SAE's)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03208764
Brief Title
Inhaled Nitric Oxide for Patients With MABSC
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 24, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
April 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beyond Air Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycobacterium Abscessus Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nitric Oxide treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nitric Oxide
Intervention Description
Subjects will be treated with 91 thirty minute sessions of 160 ppm Nitric Oxide with at least 3 hours between each session.
Primary Outcome Measure Information:
Title
Safety measured by NO-related Serious Adverse Events
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Six minute walk test
Time Frame
21 days
Title
Mycobacterium Abscesuss load in sputum
Time Frame
81 days
Title
NO-related AE's such as elevation of methemoglobin and elevation of NO2 during treatment
Time Frame
21 days
Title
Type and frequency of occurrence of NO-related Adverse Events (AE's) and Serious AE's (SAE's)
Time Frame
51 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
12. IPD Sharing Statement
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Inhaled Nitric Oxide for Patients With MABSC
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