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

Inclusion Criteria:Tracheostomy for ≥6 months with no anticipated changes to tracheostomy status within the next 3 months from screening visitMales or females 18-75 years old at time of consentWilling and able to comply with the protocol and visit scheduleSubject 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 EnglishPositive urine pregnancy test at screening and/or baseline visit, if applicableActive breastfeeding statusDiagnosis of cystic fibrosis or primary ciliary dyskinesiaHistory of lung transplantListed for lung transplantInability to tolerate nebulized treatmentsPlanned decannulation before completion of this studyExacerbation or infections requiring any acute antibiotics, urgent care visit, emergency department visit or hospitalization within 14 days of screening visitPrevious intolerance to hypertonic saline (HTS)Initiating a chronic azithromycin or any new inhaled maintenance therapy < 28 days prior to baseline visitInitiating any N-acetyl-cysteine-containing (NAC), ascorbic acid or glutathione (GSH)-containing therapy (oral or nebulized) < 28 days prior to baseline visitIntolerance to NAC or GSHIntolerance 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 dataCurrently participating in or have participated in other interventional (drug or device) clinical study within 90 days of the baseline visitReceiving a vaccination within 14 days of the baseline visit