TracheostomyPhase 1NCT05658029
An Investigator-initiated Study to Evaluate Safety and Efficacy of ARINA-1 in People With a Tracheostomy
A Phase 1 study testing ARINA-1 in people with Tracheostomy, run by Matthew Bruehl at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tracheostomy
- What is being tested?
- ARINA-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2023to 9 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
WakeMed Health & Hospitals
Raleigh, North Carolina, 27610
About this study
Official title: An Investigator-initiated Study to Evaluate Safety and Efficacy of ARINA-1 in Patients With a Tracheostomy
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
- Conditions
- Tracheostomy
- Being tested
- ARINA-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARINA-1Drug
Fixed-dose solution of ascorbic acid and reduced glutathione nebulized twice daily for 4 weeks (28 days)
| Study group | Role | What they receive |
|---|---|---|
| Open label treatment group | Experimental | Not described Receives: Drug: ARINA-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events / serious adverse events
Measured: Baseline to day 28
Secondary outcomes (6)
Change from baseline to day 28 for Composite Tracheostomy Questionnaire and the Clinical Global Impression of Change (CGI-C)
Measured: Baseline to day 28
Change in mucus rheology
Measured: Baseline to day 28
Change in bacterial culture at 28 days
Measured: Baseline to day 28
Changes in blood CRP over 28 days
Measured: Baseline to day 28
Ventilator settings / respiratory system compliance (for subjects on intermittent chronic ventilatory support)
Measured: Baseline to day 28
Peripheral Oxygen Saturation (SpO2)
Measured: Baseline to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start23 May 2023
- Primary completion9 Sep 2023
- Study completion9 Sep 2023
Why it stopped: Terminated due to enrollment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew Bruehl
- Sponsor type
- University, hospital or other
- Collaborators
- Renovion, Inc.
- Responsible party
- Sponsor-investigator, Matthew Bruehl, WakeMed Health and Hospitals
- Investigators
- Matthew Bruehl, MD, Principal investigator, WakeMed Health & Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658029
- Sponsor's protocol ID
- WMD-001
- Status last verified
- May 2024
- First submitted
- 30 Nov 2022
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-initiated Study to Evaluate Safety and Efficacy of ARINA-1 in Patients With a Tracheostomy
- ClinicalTrials.gov ID
- NCT05658029
- Acronym / sponsor ID
- WMD-001
- Conditions
- Tracheostomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated due to enrollment challenges
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Matthew BruehlUniversity, hospital or other
- Collaborators
- Renovion, Inc.
- Study start
- 23 May 2023 (actual)
- Primary completion
- 9 Sep 2023 (actual)
- Study completion
- 9 Sep 2023 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label treatment group | Experimental | Drug: ARINA-1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARINA-1Fixed-dose solution of ascorbic acid and reduced glutathione nebulized twice daily for 4 weeks (28 days) | Drug | Open label treatment group |
Primary outcome
Incidence of adverse events / serious adverse events
Time frame: Baseline to day 28
6 secondary outcomes
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
Change in mucus rheology
Time frame: Baseline to day 28
Change in bacterial culture at 28 days
Time frame: Baseline to day 28
Changes in blood CRP over 28 days
Time frame: Baseline to day 28
Ventilator settings / respiratory system compliance (for subjects on intermittent chronic ventilatory support)
Time frame: Baseline to day 28
Peripheral Oxygen Saturation (SpO2)
Time frame: Baseline to day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Bruehl, MD principal investigator
WakeMed Health & Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARINA-1 in people with Tracheostomy, run by Matthew Bruehl at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events / serious adverse events (time frame: Baseline to day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.