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NCT03748992

A Proof of Concept Study of Inhaled Nitric Oxide for Adults With Pulmonary Non-Tuberculous Mycobacterial Infection

Completed Phase 2 Results posted Last updated 18 May 2021
What this trial tests

Phase 2 trial testing gNO in Nontuberculous Mycobacterium Infection in 10 participants. Completed in 26 March 2020.

Timeline
28 January 2019
Primary endpoint
26 March 2020
26 March 2020

Quick facts

Lead sponsorMedical University of South Carolina
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date28 January 2019
Primary completion26 March 2020
Estimated completion26 March 2020
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of South Carolina

Who can join

Adults 18 to 80, any sex, with Nontuberculous Mycobacterium Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Patients With Negative Sputum Culture Primary · End of Treatment (Day 15)

Sputum culture will be assessed for any sputum growth. A negative culture represents no mycobacterial growth.

GroupValue95% CI
Inhaled Nitric Oxide (gNO)40
Number of Participants With Treatment Related Adverse Events as Assessed by the CTCAE (Common Terminology Criteria for Adverse Events) Secondary · Treatment Day 1 through End of Treatment (3 Months)

Adverse Events will be assessed by patient reporting and routine lab work

GroupValue95% CI
Inhaled Nitric Oxide (gNO)6
Number of Participants With a Reduction in Semiquantitative Cultures Secondary · At day 15 from baseline

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

GroupValue95% CI
Inhaled Nitric Oxide (gNO)4

Adverse events — posted to ClinicalTrials.gov

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.

Inhaled Nitric Oxide (gNO)
Serious: 1/10 (10%)
Deaths: 0/10

Serious adverse events (1 terms)

ReactionSystemInhaled Nitric Oxide (gNO)
Transient Ischemic AttackVascular disorders
Other adverse events (12 terms — click to expand)

ReactionSystemInhaled Nitric Oxide (gNO)
HemoptysisRespiratory, thoracic and mediastinal disorders
HeadacheNervous system disorders
Pain/pleurisyNervous system disorders
WheezingRespiratory, thoracic and mediastinal disorders
Chest tightnessCardiac disorders
Cough increasedRespiratory, thoracic and mediastinal disorders
HematocheziaGastrointestinal disorders
NauseaGastrointestinal disorders
Night sweatsGeneral disorders
ShinglesInfections and infestations
Sputum increasedRespiratory, thoracic and mediastinal disorders
VomitingGastrointestinal disorders

Most-reported serious reactions: Transient Ischemic Attack.

Data from ClinicalTrials.gov NCT03748992 adverse events section.

Sponsor's own description

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.

Publications & conference data

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

  1. Therapeutic developments for tuberculosis and nontuberculous mycobacterial lung disease.
    Dartois V, Dick T. · · 2024 · cited 68× · PMID 38418662 · DOI 10.1038/s41573-024-00897-5
  2. Meeting the challenges of NTM-PD from the perspective of the organism and the disease process: innovations in drug development and delivery.
    van der Laan R, Snabilié A, Obradovic M. · · 2022 · cited 23× · PMID 36566170 · DOI 10.1186/s12931-022-02299-w
  3. 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
  4. 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
  5. Antimicrobial Resistance: The Answers.
    Millar BC, Cates MJ, Torrisi MS, Round AJ, et al · · 2026 · PMID 41727556 · DOI 10.3389/bjbs.2026.15559
  6. Review of the Canadian Nontuberculous Mycobacterial Disease Landscape-Challenges and Opportunities.
    Vahid S, Yan M, Turvey SL. · · 2025 · PMID 41441567 · DOI 10.3390/tropicalmed10120328

Verify or expand the search:

Other recruiting trials for Nontuberculous Mycobacterium Infection

Currently open trials in the same condition.

Other Medical University of South Carolina trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03748992.

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