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:
Participant gender:
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.