Prolonged-Use of Inhaled Gaseous Nitric Oxide (gNO) for Adult With Non-Tuberculous Mycobacteria Infection

Inclusion Criteria:

• 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 Criteria:

• 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:

  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.