Mycobacterium Abscessus InfectionPhase 2NCT03208764
Inhaled Nitric Oxide for Patients With MABSC
A Phase 2 study testing Nitric Oxide in people with Mycobacterium Abscessus Infection, run by Beyond Air Inc. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Mycobacterium Abscessus Infection
- What is being tested?
- Nitric Oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Jul 2017to 11 Apr 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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).
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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.
- Conditions
- Mycobacterium Abscessus Infection
- Being tested
- Nitric Oxide
- Medical subject headings
- Mycobacterium Infections, Nontuberculous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
Subjects will be treated with 91 thirty minute sessions of 160 ppm Nitric Oxide with at least 3 hours between each session.
| Study group | Role | What they receive |
|---|---|---|
| Nitric Oxide treatment | Experimental | Not described Receives: Drug: Nitric Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by NO-related Serious Adverse Events
Measured: 21 days
Secondary outcomes (4)
Six minute walk test
Measured: 21 days
Mycobacterium Abscesuss load in sputum
Measured: 81 days
NO-related AE's such as elevation of methemoglobin and elevation of NO2 during treatment
Measured: 21 days
Type and frequency of occurrence of NO-related Adverse Events (AE's) and Serious AE's (SAE's)
Measured: 51 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start24 Jul 2017
- Primary completion1 May 2018
- Study completion11 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium Abscessus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beyond Air Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208764
- Sponsor's protocol ID
- AIT_ CP_ CFNTM_01
- Status last verified
- Jul 2017
- First submitted
- 3 Jul 2017
- Last updated
- 9 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03208764
- Acronym / sponsor ID
- AIT_ CP_ CFNTM_01
- Conditions
- Mycobacterium Abscessus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Beyond Air Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 11 Apr 2019 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nitric Oxide treatment | Experimental | Drug: Nitric Oxide |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitric OxideSubjects will be treated with 91 thirty minute sessions of 160 ppm Nitric Oxide with at least 3 hours between each session. | Drug | Nitric Oxide treatment |
Primary outcome
Safety measured by NO-related Serious Adverse Events
Time frame: 21 days
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
Related trials for Mycobacterium Abscessus Infection
RecruitingObservational study
Study of Mycobacterial Infections
Mycobacterium Infections
RecruitingObservational study
Environmental Reservoirs of Non-tuberculous Mycobacteria in Cystic Fibrosis Households
Cystic Fibrosis (CF), Mucoviscidosis
Recruiting
Hypertonic Saline Inhalation for Nontuberculous Mycobacterial Lung Disease
Nontuberculous Mycobacterial Lung Disease, Bronchiectasis
RecruitingPhase 4
The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance
Mycobacterium Abscessus Lung Disease
Enrolling by invitationPhase 1
Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection
Non-Tuberculous Mycobacterial (NTM) Pneumonia, Mycobacterium Abscessus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitric Oxide in people with Mycobacterium Abscessus Infection, run by Beyond Air Inc. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured by NO-related Serious Adverse Events (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.