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NCT03473314

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

Completed Phase 2 Last updated 29 July 2020
What this trial tests

Phase 2 trial testing Nitric Oxide gas at 160ppm in Non-Tuberculous Mycobacterial Pneumonia in 1 participant. Completed in 21 July 2020.

Timeline
9 March 2018
Primary endpoint
11 July 2020
21 July 2020

Quick facts

Lead sponsorUniversity of British Columbia
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment1
Start date9 March 2018
Primary completion11 July 2020
Estimated completion21 July 2020
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of British Columbia

Who can join

19 and older, any sex, with Non-Tuberculous Mycobacterial Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Toward better cures for <i>Mycobacterium abscessus</i> lung disease.
    Dartois V, Dick T. · · 2024 · cited 10× · PMID 39360834 · DOI 10.1128/cmr.00080-23
  2. Beyond antibiotics: recent developments in the diagnosis and management of nontuberculous mycobacterial infection.
    Gleeson LE, Waterer G. · · 2022 · cited 9× · PMID 36337137 · DOI 10.1183/20734735.0171-2021

Verify or expand the search:

Other recruiting trials for Non-Tuberculous Mycobacterial Pneumonia

Currently open trials in the same condition.

Other University of British Columbia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing