drugset / Trial / NCT05658029

An Investigator-initiated Study to Evaluate Safety and Efficacy of ARINA-1 in People With a Tracheostomy

NCT05658029

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

EvaluationDrugModalityDoseRoute
Subject Vitamin C Other / unclassified Inhaled
Subject reduced glutathione Unknown Inhaled

Indications