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

Study Overview
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Brief Summary
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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

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

Conditions
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Tracheostomy

Intervention / Treatment
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* Drug: ARINA-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Tracheostomy for ≥6 months with no anticipated changes to tracheostomy status within the next 3 months from screening visit Males or females 18-75 years old at time of consent Willing and able to comply with the protocol and visit schedule 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: Inability to speak or understand English Positive urine pregnancy test at screening and/or baseline visit, if applicable Active breastfeeding status Diagnosis of cystic fibrosis or primary ciliary dyskinesia History of lung transplant Listed for lung transplant Inability to tolerate nebulized treatments Planned decannulation before completion of this study Exacerbation or infections requiring any acute antibiotics, urgent care visit, emergency department visit or hospitalization within 14 days of screening visit Previous intolerance to hypertonic saline (HTS) Initiating a chronic azithromycin or any new inhaled maintenance therapy < 28 days prior to baseline visit Initiating any N-acetyl-cysteine-containing (NAC), ascorbic acid or glutathione (GSH)-containing therapy (oral or nebulized) < 28 days prior to baseline visit Intolerance to NAC or GSH Intolerance to bronchodilator (e.g., Albuterol) 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 Currently participating in or have participated in other interventional (drug or device) clinical study within 90 days of the baseline visit Receiving a vaccination within 14 days of the baseline visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |