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

NCT ID: NCT05658029

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-23
• Study Completion Date: 2023-09-09

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open label treatment group

Group Type: EXPERIMENTAL

ARINA-1

Intervention Type: DRUG

Fixed-dose solution of ascorbic acid and reduced glutathione nebulized twice daily for 4 weeks (28 days)

Interventions

ARINA-1

Fixed-dose solution of ascorbic acid and reduced glutathione nebulized twice daily for 4 weeks (28 days)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renovion, Inc.

INDUSTRY

Sponsor Role: collaborator

Matthew Bruehl

OTHER

Sponsor Role: lead

Responsible Party

Matthew Bruehl

M.D.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Matthew Bruehl, MD

Role: PRINCIPAL_INVESTIGATOR

WakeMed Health & Hospitals

Locations

WakeMed Health & Hospitals

Raleigh, North Carolina, United States

Countries

United States

Other Identifiers

WMD-001

Identifier Type: -

Identifier Source: org_study_id