Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents With Non-Tuberculous Mycobacteria Infection (NONTM)
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|ClinicalTrials.gov Identifier: NCT03331445|
Recruitment Status : Active, not recruiting
First Posted : November 6, 2017
Last Update Posted : October 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-Tuberculous Mycobacterial Pneumonia||Drug: Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation||Phase 2|
Primary Objective: Assess the safety of inhaled NO (gNO) in adults & adolescents with NTM
Safety will be evaluated by unanticipated adverse events in clinical labs (hematology, coagulation, and serum chemistries); in vitals; in inspired concentration of NO, O2 and NO2 delivered to each subject and; in real time methemoglobin and oxygen saturation levels.
Determine the safety of gNO in the NTM population,
• as confirmed by no unanticipated adverse events
Secondary safety Endpoint: Determine the efficacy of inhaled NO in adults with NTM.
Efficacy will be evaluated by measuring the change in lung function with spirometry (specifically absolute change in FEV1 % predicted) from baseline to Days 5, 12, 19 and 26 during and after treatment. Because deterioration of lung function is the primary cause of death in patients with NTM, absolute change in FEV1 % predicted has been used to evaluate the clinical efficacy.
Secondary Efficacy Endpoint Determine the presence of an efficacy signal of gNO in the NTM population,
Efficacy will be assessed by the antimicrobial effect of inhaled NO on the density of NTM species and other microorganisms in sputum. Serial measurements of these microbial colony counts in sputum have been previously used as a measure of antimicrobial activity in other clinical trials of antibiotics in NTM.
• as confirmed by an improvement in pre-treatment bacterial colonization and post-treatment bacterial colonization on Day 5, 12, 19 and 26.
Efficacy will be assessed by change in Quality of Life (CRISS) Score.
• as confirmed by an improvement in CRISS Score and post-treatment CRISS Score on Day 5, 12, 19 and 26.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Open label safety study|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents With Non-Tuberculous Mycobacteria Infection|
|Actual Study Start Date :||October 24, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
|Experimental: 160 ppm Nitric Oxide||
Drug: Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation
Inhaled Nitric Oxide 160ppm balance air
Other Name: Thiolanox
- Measure the safety of 160ppm inhaled nitric oxide delivery in NTM subjects [ Time Frame: 26 Days ]Measure the number of unanticipated adverse events over the duration of the study protocol
- Measure the effect of 160ppm inhaled nitric oxide delivery on lung spirometry in NTM subjects [ Time Frame: Day 5,12,19 and 26 ]Measure the change in absolute FEV1.0 change from baseline during 160 ppm inhalation therapy
- Measure the antimicrobial effect of 160ppm inhaled nitric oxide on lung NTM bacterial load in the sputum [ Time Frame: Day 5, 12, 19 and 26 ]Measure the difference from baseline NTM species bacterial load (0 to +4) in sputum during 160ppm nitric oxide inhalation therapy
- Measure the effect of 160ppm inhaled nitric oxide on Quality of Life (CRISS) Score [ Time Frame: Day 5, 12, 19 and 26 ]Measure the difference from baseline CRISS (0-100) during 160ppm nitric oxide inhalation therapy (lower score represents higher quality of life)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331445
|Canada, British Columbia|
|Vancouver, British Columbia, Canada, V5Z-1L8|
|Principal Investigator:||Jeremy D Road, MD||Professor|