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Trial record 11 of 22 for:    Recruiting, Not yet recruiting, Available Studies | antioxidants | Canada

Inhaled Gaseous Nitric Oxide (gNO) for Adults With Non-Tuberculous Mycobacteria Infection (NONTM)

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ClinicalTrials.gov Identifier: NCT03331445
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Novoteris, LLC
Information provided by (Responsible Party):
Chris Miller, University of British Columbia

Brief Summary:
Non tuberculous mycobacteria (NTM) infections in the lung are almost impossible to eradicate with conventional antibiotics. These patients have few options to treat their lung infection. It has been shown that nitric oxide was safe to be inhaled for similar cystic fibrosis patients and reduced drug resistant bacteria in the lungs. Further, research indicates that clinical isolates of NTM can be eradicated by 160ppm NO exposure in the laboratory petri dish. This is not the first time inhaled NO treatment has been used in patients with NTM (case studies). This study will provide more data to see if NO therapy can reduce the NTM bacterial load in the lungs and help the patients breath better.

Condition or disease Intervention/treatment Phase
Non-Tuberculous Mycobacterial Pneumonia Drug: Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation Phase 2

Detailed Description:

Primary Objective: Assess the safety of inhaled NO (gNO) in adults with NTM

Safety will be evaluated by unanticipated adverse events in clinical labs (hematology, coagulation, and serum chemistries); in vitals; in inspired concentration of NO, O2 and NO2 delivered to each subject and; in real time methemoglobin and oxygen saturation levels.

Primary Endpoint:

Determine the safety of gNO in the NTM population, • as confirmed by no unanticipated adverse events

Secondary safety Endpoint: Determine the efficacy of inhaled NO in adults with NTM.

Efficacy will be evaluated by measuring the change in lung function with spirometry (specifically absolute change in FEV1 % predicted) from baseline to Days 5, 12, 19 and 26 during and after treatment. Because deterioration of lung function is the primary cause of death in patients with NTM, absolute change in FEV1 % predicted has been used to evaluate the clinical efficacy.

Secondary Efficacy Endpoint Determine the presence of an efficacy signal of gNO in the NTM population,

Efficacy will be assessed by the antimicrobial effect of inhaled NO on the density of NTM species and other microorganisms in sputum. Serial measurements of these microbial colony counts in sputum have been previously used as a measure of antimicrobial activity in other clinical trials of antibiotics in NTM.

• as confirmed by an improvement in pre-treatment bacterial colonization and post-treatment bacterial colonization on Day 5, 12, 19 and 26.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Open label safety study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults With Non-Tuberculous Mycobacteria Infection
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 160 ppm Nitric Oxide Drug: Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation
Inhaled Nitric Oxide 160ppm balance air
Other Name: Thiolanox



Primary Outcome Measures :
  1. Measure the safety of 160ppm inhaled nitric oxide delivery in NTM subjects [ Time Frame: 26 Days ]
    Measure the number of unanticipated adverse events over the duration of the study protocol


Secondary Outcome Measures :
  1. Measure the effect of 160ppm inhaled nitric oxide delivery on lung spirometry in NTM subjects [ Time Frame: Day 5,12,19 and 26 ]
    Measure the change in absolute FEV1.0 from baseline during 160 ppm inhalation therapy

  2. Measure the antimicrobial effect of 160ppm inhaled nitric oxide on lung NTM bacterial load in the sputum [ Time Frame: Day 5, 12, 19 and 26 ]
    Measure the difference from baseline NTM species bacterial load in sputum during 160ppm nitric oxide inhalation therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent.
  • Has been previously diagnosed with NTM.

    1. NTM defined as positive culture(s) of at least one species of Mycobacterium avium Complex (MAC) or Mycobacterium abscessus Complex (MABSC)
    2. History of repeatedly positive cultures (2 or more), irregardless of therapy
  • Male or female ≥19 years of age.
  • Female not pregnant at time of study.
  • Has an FEV1 ≥ 30 % of predicted.
  • Oxygen saturation on room air >92% at screening.

    a. Able to breathe without supplemental oxygen for 60 minutes

  • Non-smoker for at least 6 months prior to screening and agrees not to smoke during the study.
  • Willing and able to comply with the treatment schedule and procedures.

Exclusion Criteria:

Inclusion Criteria:

  • Written informed consent.
  • Has been previously diagnosed with NTM.

    1. NTM defined as positive culture(s) of at least one species of Mycobacterium avium Complex (MAC) or Mycobacterium abscessus Complex (MABSC)
    2. History of repeatedly positive cultures (2 or more), irregardless of therapy
  • Male or female ≥19 years of age.
  • Female not pregnant at time of study.
  • Has an FEV1 ≥ 30 % of predicted.
  • Oxygen saturation on room air >92% at screening.

    o Able to breathe without supplemental oxygen for 60 minutes

  • Non-smoker for at least 6 months prior to screening and agrees not to smoke during the study.
  • Willing and able to comply with the treatment schedule and procedures.

Exclusion Criteria:

  • Use of an investigational drug within 30 days of screening
  • History of frequent epistaxis (>1 episode/month)
  • Significant hemoptysis within 30 days (≥ 5 mL of blood in one coughing episode or > 30 mL of blood in a 24 hour period)
  • History of reactive pulmonary vascular hypertension
  • Methemoglobin >3% at screening
  • Liver function insufficiency (ALT/ AST >3 of normal values)
  • Hemoglobin <11 g/dl
  • Thrombocytopenia (platelet count <100,000/mm3) at screening
  • Prothrombin time international ratio (INR) > 1.3 at screening
  • Changes to antibiotics (e.g. azithromycin) from 7 days prior to screening through last treatment day. (Subjects may be taking antibiotics during this time period, but they cannot start, stop or change doses during this time period)
  • Organ transplant recipient.
  • On supplemental oxygen during gNO treatment (SaO2 < 90% for 50 minutes while resting in a chair).
  • For women of child bearing potential:

    1. positive pregnancy test at screening or
    2. lactating or
    3. unwilling to practice a medically acceptable form of contraception from screening to Day 36 (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent)
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

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): NCT03331445


Contacts
Contact: Chris C Miller, Ph.D. 778-899-0607 miller42@mail.ubc.ca

Locations
Canada, British Columbia
Diamond Centre Recruiting
Vancouver, British Columbia, Canada, V5Z-1L8
Contact: Chris C Miller, Ph.D    778-899-0607    miller42@mail.ubc.ca   
Sponsors and Collaborators
University of British Columbia
Novoteris, LLC
Investigators
Principal Investigator: Jeremy D Road, MD Professor

Publications:
Responsible Party: Chris Miller, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT03331445     History of Changes
Other Study ID Numbers: NTM-CTP-01: H17-02107
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Chris Miller, University of British Columbia:
inhaled nitric oxide
non tuberculous mycobacteria
drug resistant pneumonia

Additional relevant MeSH terms:
Antioxidants
Pneumonia
Mycobacterium Infections
Mycobacterium Infections, Nontuberculous
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract 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
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents