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ARINA-1 for Tracheostomy Care

Phase 1
Recruiting
Led By Matthew Bruehl, MD
Research Sponsored by Matthew Bruehl
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females 18-75 years old at time of consent
Tracheostomy for ≥6 months with no anticipated changes to tracheostomy status within the next 3 months from screening visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 28
Awards & highlights

Study Summary

This trial will study the safety & effectiveness of a nebulized solution for people with a tracheostomy, with check-ups at Screening, Baseline & Days 14, 28 & 56, plus 3 safety phone calls.

Who is the study for?
Adults aged 18-75 with a tracheostomy for at least 6 months can join this study. They must be able to follow the study plan and give informed consent. People cannot participate if they have had lung transplants, are listed for one, or can't handle nebulized treatments.Check my eligibility
What is being tested?
The trial is testing ARINA-1's safety and effectiveness when nebulized twice daily for 28 days by people with a tracheostomy. Participants will visit the clinic several times and make three safety calls over two months.See study design
What are the potential side effects?
While specific side effects of ARINA-1 aren't listed, similar inhaled solutions may cause coughing, throat irritation or discomfort during inhalation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 75 years old.
Select...
I have had a tracheostomy for at least 6 months with no changes expected soon.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events / serious adverse events
Secondary outcome measures
Change from baseline to day 28 for Composite Tracheostomy Questionnaire and the Clinical Global Impression of Change (CGI-C)
Change in bacterial culture at 28 days
Change in mucus rheology
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open label treatment groupExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARINA-1
2022
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Matthew BruehlLead Sponsor
Renovion, Inc.Industry Sponsor
2 Previous Clinical Trials
140 Total Patients Enrolled
Matthew Bruehl, MDPrincipal InvestigatorWakeMed Health & Hospitals

Media Library

ARINA-1 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05658029 — Phase 1
Tracheostomy Care Research Study Groups: Open label treatment group
Tracheostomy Care Clinical Trial 2023: ARINA-1 Highlights & Side Effects. Trial Name: NCT05658029 — Phase 1
ARINA-1 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05658029 — Phase 1
Tracheostomy Care Patient Testimony for trial: Trial Name: NCT05658029 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the participant pool of this research endeavor restricted to those aged sixty and above?

"This research endeavor is targeting individuals aged 18 to 75 years."

Answered by AI

What risks could be associated with Open label treatment group?

"The Open Label Treatment Group has a safety rating of 1, as it is only in its first phase of testing and limited data exists on the efficacy and safety profile."

Answered by AI

Is it possible to enroll in this research program at present?

"According to clinicaltrials.gov, this ongoing medical trial is actively enrolling participants. It was initially posted on December 1st 2022 and recently revised on the 12th of December in the same year."

Answered by AI

How many participants may enroll in this experiment?

"Affirmative. The information posted on clinicaltrials.gov evidences that this research project is actively recruiting participants, with 25 people needed to be recruited from a single medical centre. This trial was first published on December 1st 2022 and has most recently been updated on the 12th of December in the same year."

Answered by AI

Who is eligible to participate in this research project?

"This clinical trial is recruiting 25 individuals who have been receiving tracheostomy care for a minimum of 6 months, with no expected changes to their status in the next 3 months. Eligibility criteria are as follows: Patients must be between 18 and 75 years old (both genders accepted), willing and able to comply with study-related protocol, capable of providing informed consent as per principles set forth by the Declaration of Helsinki and WakeMed Health & Hospitals guidance."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I've tried medication for several years for my mood disorders and nothing seems to help me as much as I'd like.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
An Investigator-initiated Study to Evaluate Safety and Efficacy of ARINA-1 in People With a Tracheostomy
Matthew Bruehl 2022. "An Investigator-initiated Study to Evaluate Safety and Efficacy of ARINA-1 in People With a Tracheostomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05658029.
~6 spots leftby Oct 2024
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