Status:
COMPLETED
Prolonged-Use of Inhaled Gaseous Nitric Oxide (gNO) for Adult With Non-Tuberculous Mycobacteria Infection
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Mallinckrodt
Conditions:
Non-Tuberculous Mycobacterial Pneumonia
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
An open labeled Study (NCT03331445) is demonstrating encouraging safety and efficacy results for most subjects receiving 160ppm nitric oxide gas (gNO) for treatment of non-tuberculous mycobacteria (NT...
Detailed Description
Primary Objective: Determine the efficacy of prolonged delivery of inhaled nitric oxide to treat an adult patient with pulmonary NTM Primary Endpoint: Eradication of NTM growth in sputum cultures. Eff...
Eligibility Criteria
Inclusion
- Written informed consent.
- Has been previously diagnosed with NTM. \[NTM defined as positive culture(s) of at least one species of Mycobacterium avium Complex (MAC) or Mycobacterium abscessus Complex (MABSC)\]
- Has been previously treated with gNO for 15 days without complete eradication of NTM but with a decrease of at least 1-2 points on cultures.
- Male or female ≥19 years of age.
- Female not pregnant at time of study.
- Oxygen saturation on room air ≥92% at screening. (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
- History of frequent epistaxis (\>1 episode/month)
- History of reactive pulmonary vascular hypertension
- Methemoglobin \>3% at screening
- Liver function insufficiency aspartate aminotransferase/alanine aminotransferase (AST/ALT) \>3 of normal values)
- Hemoglobin \<10 g/dl
- Thrombocytopenia (platelet count \<100,000/mm3) at screening
- Prothrombin time international ratio (INR) \> 1.3 at screening
- On supplemental oxygen during gNO treatment (SaO2 \< 90% for 50 minutes while resting in a chair).
- For women of child bearing potential:
- positive pregnancy test at screening or
- lactating or
- 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.
Key Trial Info
Start Date :
March 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03473314
Start Date
March 9 2018
End Date
July 21 2020
Last Update
July 29 2020
Active Locations (1)
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1
Gordon Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada, V5Z-1L8