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

Matthew Bruehl1 site in 1 countryMay 23, 2023

ConditionsTracheostomy

InterventionsARINA-1

DrugsARINA-1

Overview

Phase: Phase 1
Intervention: ARINA-1
Conditions: Tracheostomy
Sponsor: Matthew Bruehl
Locations: 1
Primary Endpoint: Incidence of adverse events / serious adverse events
Status: Withdrawn
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

May 23, 2023

End Date

September 9, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Matthew Bruehl

Responsible Party

Sponsor Investigator

Principal Investigator

Matthew Bruehl

M.D.

WakeMed Health and Hospitals

Eligibility Criteria

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)

Arms & Interventions

Open label treatment group

Intervention: ARINA-1

Outcomes

Primary Outcomes

Incidence of adverse events / serious adverse events

Time Frame: Baseline to day 28

Secondary Outcomes

Change from baseline to day 28 for Composite Tracheostomy Questionnaire and the Clinical Global Impression of Change (CGI-C)(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)
Change in bacterial culture at 28 days(Baseline to day 28)
Change in mucus rheology(Baseline to day 28)
Peripheral Oxygen Saturation (SpO2)(Baseline to day 28)