drugset / Trial / NCT05658029
An Investigator-initiated Study to Evaluate Safety and Efficacy of ARINA-1 in People With a Tracheostomy
NaSingle-groupOpen-labelTreatment
Summary
The goal of this investigator-initiated, open label study is to evaluate the safety and efficacy of ARINA-1 in people with a tracheostomy. Participants will attend study visits at Screening, Baseline, Day 14, Day 28, and Day 56. There will be 3 safety phone calls at Days 2, 7, and 21. Participants will nebulize the ARINA-1 solution twice daily for 28 days
Timeline
- Start
- 2023-05-23
- Primary completion
- 2023-09-09
- Completion
- 2023-09-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vitamin C | Other / unclassified | — | Inhaled |
| Subject | reduced glutathione | Unknown | — | Inhaled |