NCT03748992

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Nontuberculous Mycobacterium Infection

Interventions

Type	Name	Description
DRUG	gNO	This is a proof-of-concept study in which all subjects will be treated with gNO (i.e. no control) to see if there can be a microbiological effect by conversion to negative sputum cultures and how long that effect can be sustained following treatment. Participants will be treated for 3 weeks (5 days per week), Monday through Friday, and followed monthly for 3 months. The treatment period includes a physical exam, vital signs, blood tests, echocardiogram, spirometry test, sputum sample, questionnaires, and the inhalation gas treatment. During the inhalation gas treatment, participants will wear a face mask (similar to an oxygen mask) and will be given nitric oxide gas through the participants nose for three treatments with fifty minutes each time. They will then be followed up monthly during the Follow-up period with tests that include a physical exam and questionnaires.

Timeline

• Start date: 2019-01-28
• Primary completion: 2020-03-26
• Completion: 2020-03-26
• First posted: 2018-11-21
• Last updated: 2021-05-18
• Results posted: 2021-05-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study