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Inhaled Nitric Oxide for Patients With MABSC

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ClinicalTrials.gov Identifier: NCT03208764
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Advanced Inhalation Therapies Ltd

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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 : December 15, 2017
Estimated Study Completion Date : April 15, 2018

Resource links provided by the National Library of Medicine


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.




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 ]


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208764


Contacts
Contact: Rinat Kalaora, M. Sc +972-544750887 Rinatk@ait-pharm.com
Contact: Mark Mizrahi, Ph.D +972-524502245 Marko@ait-pharm.com

Locations
Israel
Rambam Medical Center Recruiting
Haifa, Israel
Sponsors and Collaborators
Advanced Inhalation Therapies Ltd

Responsible Party: Advanced Inhalation Therapies Ltd
ClinicalTrials.gov Identifier: NCT03208764     History of Changes
Other Study ID Numbers: AIT_ CP_ CFNTM_01
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: February 7, 2018
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
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