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

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ClinicalTrials.gov Identifier: NCT05658029
Recruitment Status : Recruiting
First Posted : December 20, 2022
Last Update Posted : December 27, 2022
Sponsor:
Collaborator:
Renovion, Inc.
Information provided by (Responsible Party):
Matthew Bruehl, WakeMed Health and Hospitals

Study Description
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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


Condition or disease Intervention/treatment Phase
Tracheostomy Drug: ARINA-1 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Investigator-initiated Study to Evaluate Safety and Efficacy of ARINA-1 in Patients With a Tracheostomy
Estimated Study Start Date : December 2022
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Open label treatment group Drug: ARINA-1
Fixed-dose solution of ascorbic acid and reduced glutathione nebulized twice daily for 4 weeks (28 days)


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events / serious adverse events [ Time Frame: Baseline to day 28 ]

Secondary Outcome Measures :
  1. Change from baseline to day 28 for Composite Tracheostomy Questionnaire and the Clinical Global Impression of Change (CGI-C) [ Time Frame: Baseline to day 28 ]
  2. Change in mucus rheology [ Time Frame: Baseline to day 28 ]
  3. Change in bacterial culture at 28 days [ Time Frame: Baseline to day 28 ]
  4. Changes in blood CRP over 28 days [ Time Frame: Baseline to day 28 ]
  5. Ventilator settings / respiratory system compliance (for subjects on intermittent chronic ventilatory support) [ Time Frame: Baseline to day 28 ]
  6. Peripheral Oxygen Saturation (SpO2) [ Time Frame: Baseline to day 28 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05658029


Contacts
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Contact: LaMonica Daniel 919-350-8000 ladaniel@wakemed.org

Locations
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United States, North Carolina
WakeMed Health & Hospitals Recruiting
Raleigh, North Carolina, United States, 27610
Principal Investigator: Matthew Bruehl, MD         
Sub-Investigator: Laura Dosier, MD         
Sponsors and Collaborators
Matthew Bruehl
Renovion, Inc.
Investigators
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Principal Investigator: Matthew Bruehl, MD WakeMed Health & Hospitals
More Information
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Responsible Party: Matthew Bruehl, M.D., WakeMed Health and Hospitals
ClinicalTrials.gov Identifier: NCT05658029    
Other Study ID Numbers: WMD-001
First Posted: December 20, 2022    Key Record Dates
Last Update Posted: December 27, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No