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

• Status: Completed
• Trial end date: 2020-07-21
• Target enrollment: 0
• Participant gender: All

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 (NTM) over a 15 day treatment regimen. In one subject, who had a reduction in sputum culture concentration of Bacterium bolletii from plus 3 to plus 1 corresponding to a 2-3 log10 cfu/gm reduction during the treatment, the one-week post treatment follow-up sputum culture had increased to plus 2. It is hypothesized that a longer treatment period may be necessary to fully eradicate NTM from the sputum culture in chronic lung disease. This study will extend the period of gNO exposure for a prolonged period of time (3 months) to attempt to fully eradicate the NTM in this single subject. This study will transition from the medical clinic to supervised delivery in the patient's home environment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborators: Mallinckrodt; Novoteris, LLC
• Treatments: Nitric Oxide

Criteria

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.