Sputum culture will be assessed for any sputum growth. A negative culture represents no mycobacterial growth.
| Group | Value | 95% CI |
|---|---|---|
| Inhaled Nitric Oxide (gNO) | 40 |
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A Proof of Concept Study of Inhaled Nitric Oxide for Adults With Pulmonary Non-Tuberculous Mycobacterial Infection
Phase 2 trial testing gNO in Nontuberculous Mycobacterium Infection in 10 participants. Completed in 26 March 2020.
| Lead sponsor | Medical University of South Carolina |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 28 January 2019 |
| Primary completion | 26 March 2020 |
| Estimated completion | 26 March 2020 |
| Sites | 2 locations across United States |
Medical University of South Carolina
Adults 18 to 80, any sex, with Nontuberculous Mycobacterium Infection. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Sputum culture will be assessed for any sputum growth. A negative culture represents no mycobacterial growth.
| Group | Value | 95% CI |
|---|---|---|
| Inhaled Nitric Oxide (gNO) | 40 |
Adverse Events will be assessed by patient reporting and routine lab work
| Group | Value | 95% CI |
|---|---|---|
| Inhaled Nitric Oxide (gNO) | 6 |
Semiquantitative Culture Score is an assessment of bacterial burden with a lower score suggesting a lesser bacterial burden. The Semiquantitative Culture Score at Day 15 was compared to baseline, and a reduction in the Semiquantitative Culture Score suggests a reduced bacterial burden with treatment. Cultures were reported as positive if growth occurs in broth medium only; growth on broth medium plus solid medium cultures with countable colonies will be reported as 0-49 colonies, 1+; solid medium growth with 50-99 colonies, 2+; solid medium growth with 100-199 colonies; 3+, solid medium growt
| Group | Value | 95% CI |
|---|---|---|
| Inhaled Nitric Oxide (gNO) | 4 |
Time frame: Patients were assessed for AE's throughout the duration of the study, approximately 3 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Inhaled Nitric Oxide (gNO) |
|---|---|---|
| Transient Ischemic Attack | Vascular disorders | — |
| Reaction | System | Inhaled Nitric Oxide (gNO) |
|---|---|---|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | — |
| Headache | Nervous system disorders | — |
| Pain/pleurisy | Nervous system disorders | — |
| Wheezing | Respiratory, thoracic and mediastinal disorders | — |
| Chest tightness | Cardiac disorders | — |
| Cough increased | Respiratory, thoracic and mediastinal disorders | — |
| Hematochezia | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Night sweats | General disorders | — |
| Shingles | Infections and infestations | — |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
Most-reported serious reactions: Transient Ischemic Attack.
Data from ClinicalTrials.gov NCT03748992 adverse events section.
The purpose of this study is to evaluate the efficacy and safety of open-label exposure of gNO in patients with NTM lung disease. Subjects will receive the study drug by inhaling through a nasal mask. Subjects will be treated for 3 weeks (5 days per week) and followed monthly for 3 months.
6 peer-reviewed publications reference this trial (live from Europe PMC):
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