Clinical trial NCT05658029: An Investigator-initiated Study to Evaluate Safety and Efficacy of ARINA-1 in People With a Tracheostomy
Official title: An Investigator-initiated Study to Evaluate Safety and Efficacy of ARINA-1 in Patients With a Tracheostomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Tracheostomy
Lead sponsor: WakeMed Health and Hospitals
Sponsor class: OTHER
Collaborators: name: Renovion, Inc.
First posted: 2022-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Incidence of adverse events / serious adverse events
timeFrame: Baseline to day 28
Secondary outcomes:
measure: Change from baseline to day 28 for Composite Tracheostomy Questionnaire and the Clinical Global Impression of Change (CGI-C)
timeFrame: Baseline to day 28
measure: Change in mucus rheology
timeFrame: Baseline to day 28
measure: Change in bacterial culture at 28 days
timeFrame: Baseline to day 28
measure: Changes in blood CRP over 28 days
timeFrame: Baseline to day 28
measure: Ventilator settings / respiratory system compliance (for subjects on intermittent chronic ventilatory support)
timeFrame: Baseline to day 28
measure: Peripheral Oxygen Saturation (SpO2)
timeFrame: Baseline to day 28
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: WakeMed Health & Hospitals
state: North Carolina
Study officials:
affiliation: WakeMed Health & Hospitals
name: Matthew Bruehl, MD
role: PRINCIPAL_INVESTIGATOR
References: