An Investigator-initiated Study to Evaluate Safety and Ef... | NCT05658029

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

NCT05658029

Sponsor

Matthew Bruehl

Status

Withdrawn

Last Update Posted

May 14, 2024Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Tracheostomy

Interventions

ARINA-1

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated due to enrollment challenges

Expanded Access Info

Start Date

May 23, 2023Actual

Primary Completion Date

Sep 9, 2023Actual

Completion Date

Sep 9, 2023Actual

First Submitted Date

Nov 30, 2022

First Submission Date that Met QC Criteria

Dec 12, 2022

First Posted Date

Dec 20, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2024

Last Update Posted Date

May 14, 2024Actual

Name	Class
Renovion, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Open label treatment group	Experimental		Drug: ARINA-1

Name	Type	Description	Arm Group Labels	Other Names
ARINA-1	Drug	Fixed-dose solution of ascorbic acid and reduced glutathione nebulized twice daily for 4 weeks (28 days)	Open label treatment group

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

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

Eligibility Module

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)
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided