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

Tracheostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05658029
• Other study ID #: WMD-001
• Status: Recruiting
• Phase: Phase 1
• Start date: December 2022
• Est. completion date: October 2024

Study information

• Verified date: December 2022
• Source: WakeMed Health and Hospitals
• Contact: LaMonica Daniel
• Phone: 919-350-8000
• Email: ladaniel[@]wakemed.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Tracheostomy

Intervention

Drug:
• ARINA-1
Fixed-dose solution of ascorbic acid and reduced glutathione nebulized twice daily for 4 weeks (28 days)

Locations

Country	Name	City	State
United States	WakeMed Health & Hospitals	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Matthew Bruehl	Renovion, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events / serious adverse events		Baseline to day 28
Secondary	Change from baseline to day 28 for Composite Tracheostomy Questionnaire and the Clinical Global Impression of Change (CGI-C)		Baseline to day 28
Secondary	Change in mucus rheology		Baseline to day 28
Secondary	Change in bacterial culture at 28 days		Baseline to day 28
Secondary	Changes in blood CRP over 28 days		Baseline to day 28
Secondary	Ventilator settings / respiratory system compliance (for subjects on intermittent chronic ventilatory support)		Baseline to day 28
Secondary	Peripheral Oxygen Saturation (SpO2)		Baseline to day 28