NCT05658029

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

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Matthew Bruehl · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Tracheostomy

Interventions

Type	Name	Description
DRUG	ARINA-1	Fixed-dose solution of ascorbic acid and reduced glutathione nebulized twice daily for 4 weeks (28 days)

Timeline

• Start date: 2023-05-23
• Primary completion: 2023-09-09
• Completion: 2023-09-09
• First posted: 2022-12-20
• Last updated: 2024-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study