Tracheostomy
Conditions
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
Interventions
DRUGARINA-1
Fixed-dose solution of ascorbic acid and reduced glutathione nebulized twice daily for 4 weeks (28 days)
Sponsors
Renovion, Inc.
Matthew Bruehl
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events / serious adverse events | Baseline to day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Change in mucus rheology | Baseline to day 28 |
| Change in bacterial culture at 28 days | Baseline to day 28 |
| Change from baseline to day 28 for Composite Tracheostomy Questionnaire and the Clinical Global Impression of Change (CGI-C) | 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 |
| Changes in blood CRP over 28 days | Baseline to day 28 |
Countries
United States
Outcome results
None listed