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

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

Study Overview

• Status: Withdrawn
• Conditions: Tracheostomy
• Intervention / Treatment: Drug: ARINA-1

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • WakeMed Health & Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Tracheostomy for ≥6 months with no anticipated changes to tracheostomy status within the next 3 months from screening visit
2. Males or females 18-75 years old at time of consent
3. Willing and able to comply with the protocol and visit schedule
4. Subject or legal authorized representative capable of giving informed consent. Determination of subject capacity to give informed consent will be determined by investigators and guided by principles set forth in the Declaration of Helsinki (World Medical Association, 2013) and by WakeMed Health & Hospitals guidance (Patient Competency and Decisional Capacity - Legal Affairs Tip Sheet/FAQ).

Exclusion Criteria:

1. Inability to speak or understand English
2. Positive urine pregnancy test at screening and/or baseline visit, if applicable
3. Active breastfeeding status
4. Diagnosis of cystic fibrosis or primary ciliary dyskinesia
5. History of lung transplant
6. Listed for lung transplant
7. Inability to tolerate nebulized treatments
8. Planned decannulation before completion of this study
9. Exacerbation or infections requiring any acute antibiotics, urgent care visit, emergency department visit or hospitalization within 14 days of screening visit
10. Previous intolerance to hypertonic saline (HTS)
11. Initiating a chronic azithromycin or any new inhaled maintenance therapy < 28 days prior to baseline visit
12. Initiating any N-acetyl-cysteine-containing (NAC), ascorbic acid or glutathione (GSH)-containing therapy (oral or nebulized) < 28 days prior to baseline visit
13. Intolerance to NAC or GSH
14. Intolerance to bronchodilator (e.g., Albuterol)
15. Significant comorbidities that in the opinion of the investigator would reduce the safety of the subject or interfere with the ability to interpret study data
16. Currently participating in or have participated in other interventional (drug or device) clinical study within 90 days of the baseline visit
17. Receiving a vaccination within 14 days of the baseline visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open label treatment group	Drug: ARINA-1; Fixed-dose solution of ascorbic acid and reduced glutathione nebulized twice daily for 4 weeks (28 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events / serious adverse events	Baseline to day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to day 28 for Composite Tracheostomy Questionnaire and the Clinical Global Impression of Change (CGI-C)	Baseline to day 28
Change in mucus rheology	Baseline to day 28
Change in bacterial culture at 28 days	Baseline to day 28
Changes in blood CRP over 28 days	Baseline to day 28
Ventilator settings / respiratory system compliance (for subjects on intermittent chronic ventilatory support)	Baseline to day 28
Peripheral Oxygen Saturation (SpO2)	Baseline to day 28

Collaborators and Investigators

• Sponsor: Matthew Bruehl
• Collaborators: Renovion, Inc.
• Investigators: Principal Investigator: Matthew Bruehl, MD, WakeMed Health & Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Actual): September 9, 2023
• Study Completion (Actual): September 9, 2023

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: WMD-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No