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Mucolytic Agent

ARINA-1 for Bronchiectasis

Phase 2

Waitlist Available

Led By Charles L Daley, MD

Research Sponsored by Renovion, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 56 days

Awards & highlights

Study Summary

This trial is testing a new medication for bronchiectasis called ARINA-1. The trial will last 28 days, and participants will be randomly assigned to either take ARINA-1 or a placebo twice daily. The trial will measure the safety and efficacy of ARINA-1 by looking at quality of life, sputum rheological markers, and blood inflammatory markers.

Who is the study for?

This trial is for adults with non-CF bronchiectasis, able to cough up sputum, not currently smoking, and stable on their current lung treatments. They must have a certain level of lung function (FEV1 > 40%), be fully vaccinated against COVID-19, and can't be using supplemental oxygen or have had recent exacerbations or changes in medications.Check my eligibility

What is being tested?

The study tests ARINA-1 versus a placebo saline solution over 28 days to see if it improves life quality and reduces mucus and inflammation in patients with non-CF bronchiectasis. Participants will receive the treatment twice daily, with outcomes measured by questionnaires and blood/sputum tests.See study design

What are the potential side effects?

While specific side effects are not listed here, participants may experience reactions related to ARINA-1 or the placebo. These could include typical drug-related symptoms such as nausea, headaches, respiratory issues or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~56 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Therapeutic procedure

Proportion of participants that experience each treatment-emergent adverse event

Secondary outcome measures

Compare FEF25-75 between the ARINA-1 and treatment arms

Therapeutic procedure

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ARINA-1Experimental Treatment1 Intervention

ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH); fixed dose, 4 mL solution inhaled twice daily via nebulization for 28 days

Group II: PlaceboPlacebo Group1 Intervention

Isotonic saline (0.9%); 4 mL solution inhaled twice daily via nebulization for 28 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ARINA-1

2022

Completed Phase 2

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Renovion, Inc.Lead Sponsor

2 Previous Clinical Trials

125 Total Patients Enrolled

Charles L Daley, MDPrincipal InvestigatorNational Jewish Health

Frequently Asked Questions

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

What is the sample size of this empirical research?

"Renovion, Inc. needs to enlist 50 eligible participants for the trial across two sites: Oregon Health and Science University (Portland) and Jefferson Hospital (Philadelphia)."

Answered by AI

Is the eligibility for this trial contingent on a participant's age exceeding twenty years?

"The requirements for entry into this trial are that applicants must be between 18 and 80 years old. Additionally, there are two substudies available to people below the age of eighteen and 35 spots reserved for those over 65."

Answered by AI

Are there any Canadian medical facilities currently conducting this clinical experiment?

"Nine medical centers are currently recruiting patients for this trial, including Oregon Health and Science University in Portland, Jefferson Hospital in Philadelphia, as well as the University of Alabama - Birmingham. There are 6 additional clinical sites participating in this experiment."

Answered by AI

Is it feasible for me to join in this clinical experiment?

"This clinical trial seeks 50 patients aged between 18 and 80 who are living with bronchiectasis. Furthermore, the participants must have a confirmed NCFBE diagnosis through chest CT scans, be over BMI 18, exhibit > 40% predicted FEV1 pre-bronchodilator levels in addition to being steady on an airway clearance technique (ACT) regimen for 90 days prior and stable on standard of care therapy during this same period. Moreover, applicants need to produce proof that they were fully vaccinated against COVID-19 at least two weeks before their screening visit as well as evidence that they can generate sputum samples if"

Answered by AI

Is this research currently open to recruitment?

"Clinicaltrials.gov confirms that this investigation is seeking participants, with the original posting being on October 3rd 2022 and a final edit made on November 4th of the same year."

Answered by AI

Has the ARINA-1 drug been granted formal authorization by the FDA?

"Assessed on a 1 to 3 scale, ARINA-1's safety was estimated as a 2 due to the available Phase 2 clinical trial data that suggests its safety but has yet to demonstrate efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2a, 28-day Investigational Use Study of ARINA-1 in Non-CF Bronchiectasis With Excess Mucus and Cough

2022. "Phase 2a, 28-day Investigational Use Study of ARINA-1 in Non-CF Bronchiectasis With Excess Mucus and Cough". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05495243.