Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Inhaled Nitric Oxide for Patients With MABSC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208764
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Beyond Air Ltd

Tracking Information
First Submitted Date  ICMJE July 3, 2017
First Posted Date  ICMJE July 6, 2017
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE July 24, 2017
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2017)
Safety measured by NO-related Serious Adverse Events [ Time Frame: 21 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhaled Nitric Oxide for Patients With MABSC
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mycobacterium Abscessus Infection
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Nitric Oxide treatment
Intervention: Drug: Nitric Oxide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2019)
9
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2017)
10
Actual Study Completion Date  ICMJE April 11, 2019
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03208764
Other Study ID Numbers  ICMJE AIT_ CP_ CFNTM_01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beyond Air Ltd
Study Sponsor  ICMJE Beyond Air Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beyond Air Ltd
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP