Open Label Prolonged-Use of Inhaled Gaseous Nitric Oxide (gNO) for a Single Adult With Non-Tuberculous Mycobacteria Infection
Sponsor study identifier
interventional
1
1 country
1
Study Start
March 9, 2018
Actual (reported)Primary Completion
July 11, 2020
Actual (reported)Study Completion
July 21, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 21, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 9, 2018
Actual (reported)March 14, 2018
Actual (reported)March 22, 2018
Actual (reported)July 11, 2020
Actual (reported)July 21, 2020
Actual (reported)Eradication of NTM in sputum
The primary efficacy variable for this study is eradication of recovered NTM organisms in sputum colony forming unit (CFU) g (log 10) from baseline. Eradication will be defined as two negative sputum cultures post nitric oxide gas treatment over 60 days.
365 days
Mean absolute change in forced expiratory volume at one second (FEV1)% from baseline.
365 days
Mean change in distance walked in the six-minute walk test from baseline
365 days
Mean change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) scores for each domain from baseline
365 days
Recurrence of NTM in sputum culture post NTM eradication.
30 and 60 days post NTM eradication
Nitric oxide delivery effect on clinical values in home delivery
365 days
Nitric Oxide 160ppm for 50-80 minutes two -three times a day for 365 days
Nitric oxide gas at 160 ppm inhaled three times daily for 50-80 min delivered with air as the carrier via inhalation for a maximum total of 90 days (extended 365 days twice). Total dose of 480 ppm hours per day.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Gordon Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z-1L8, Canada
Jeremy Road, MD
University of British Columbia
1 participants (actual enrollment reported by the registry).
First Submitted
March 14, 2018
First Posted
March 22, 2018
Study Start
March 9, 2018
Actual (reported)Multiplex PCR -Microarray-based Assay in the Detection of Mycobacterium
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Primary Completion
July 11, 2020
Actual (reported)Study Completion
July 21, 2020
Actual (reported)Last Updated
July 29, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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