Non-cystic Fibrosis BronchiectasisPhase 2NCT05495243
Phase 2a, 28-day Investigational Use Study of ARINA-1 in Non-Cystic Fibrosis Bronchiectasis (NCFBE) With Excess Mucus and Cough
A Phase 2 study testing ARINA-1 in people with Non-cystic Fibrosis Bronchiectasis, run by Renovion, Inc. at 10 sites in United States.
Trial summary
This is a randomized, Phase 2a, double-blind, placebo-controlled study to evaluate the safety and efficacy of ARINA-1 compared to placebo (isotonic saline, 0.9%) in participants with NCFBE. Study participants will receive either study treatment or placebo twice daily for 28 days. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis
- What is being tested?
- ARINA-1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 10 sitesUnited States
- Study dates
- 3 Oct 2022to 1 Feb 2024
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of NCFBE confirmed by chest CT
- 18-80 years old, inclusive at time of informed consent
- BMI >18
- Percent predicted FEV1 > 40%, pre-bronchodilator
- Stable for 90 days with any airway clearance technique (ACT) method(s)
- Stable on standard of care (SOC) therapy for 90 days (includes cycling antibiotics, such as inhaled tobramycin, and long-term macrolide therapy) and not likely, in the opinion of the investigator, to require any changes to therapy during the duration of study participation
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- Fully vaccinated for COVID-19 (second dose of a 2-shot regimen or single dose of 1-shot regimen completed >14 days prior to the screening visit)
- Must be able to produce a sputum sample
- If female and of childbearing potential, must be willing to use contraception for the duration of the study.
Who cannot join
- Positive urine pregnancy test for women of childbearing potential (WOCBP) at screening and baseline visit
- Active exacerbation ≤28 days prior to the baseline visit
- Initiating or changing antibiotic, antiviral, or antifungal therapy ≤ 28 days prior to the baseline visit
- Changing or initiating any vitamin C, glutathione or N-acetyl-cysteine-containing therapy or multivitamin within 30 says prior to the screening visit.
- Positive COVID-19 diagnostic test (PCR or antigen) within 90 days prior to the screening visit.
- Participated in other interventional drug or device studies within 30 days of the screening visit (Note: observational studies are acceptable)
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- Significant unstable comorbidities (in the opinion of the site investigator), such as heart failure, cardiovascular disease, diabetes, renal disease, liver disease
- Current tobacco or marijuana smoker (those with active smoking exposure <180 days prior to the screening visit) (Note: edibles are acceptable)
- Requiring the use of any supplemental oxygen
- Currently on cycled antibiotics (e.g., tobramycin) or have been on a cycled antibiotic regimen within 90 days prior to the screening visit.
- Current diagnosis of non-tuberculous mycobacteria (NTM) requiring antibiotic treatment. (Participants who test positive for NTM but who are not currently on antibiotic therapy are eligible for screening)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Johns Hopkins
Baltimore, Maryland, 21205
University of Alabama - Birmingham
Birmingham, Alabama, 35294
Medical University of South Carolina
Charleston, South Carolina, 29425
National Jewish Hospital
Denver, Colorado, 80206
Louisiana State University
New Orleans, Louisiana, 70803
Jefferson Hospital
Philadelphia, Pennsylvania, 19107
Oregon Health and Science University
Portland, Oregon, 97239
University of Texas - Tyler
Tyler, Texas, 29425
Georgetown University
Washington D.C., District of Columbia, 20007
Southeastern Research Center
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ARINA-1 in Adult Participants With Non-cystic Fibrosis Bronchiectasis (NCFBE) With Excess Mucus and Cough
This is a randomized, Phase 2a, double-blind, placebo-controlled study to evaluate the safety and efficacy of ARINA-1 compared to placebo (isotonic saline, 0.9%) in participants with NCFBE. Study participants will receive either study treatment or placebo twice daily for 28 days. Efficacy endpoints will include quality of life, sputum rheological markers, and blood inflammatory markers. Quality of life will be measured using the following tools: Quality of Life-Bronchiectasis (QOL-B) questionnaire, St. George's Respiratory Questionnaire (SGRQ), Chronic Airways Assessment Test (CAAT), and a daily clinical global impression questionnaire.
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Being tested
- ARINA-1, Placebo
- Keywords
- bronchiectasis
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARINA-1Drug
ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH)
PlaceboDrug
Isotonic saline (0.9%)
| Study group | Role | What they receive |
|---|---|---|
| ARINA-1 | Experimental | 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 Receives: Drug: ARINA-1 |
| Placebo | Placebo comparator | Isotonic saline (0.9%); 4 mL solution inhaled twice daily via nebulization for 28 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Incidence of participants that experience an adverse event following administration of treatment
Measured: 56 days
Proportion of participants that experience each treatment-emergent adverse event
Measured: 56 days
Secondary outcomes (11)
Compare quality of life (as measured by CAAT questionnaire) between the ARINA-1 and placebo arms
8 questions rated on a 0-5 scale
Measured: 56 days
Compare quality of life (as measured by SGRQ) between the ARINA-1 and placebo arms
42 questions, ranked on a 5-point descriptive scale or true/false
Measured: 56 days
Compare quality of life (as measured by QOL-B) between the ARINA-1 and placebo arms
37 questions ranked on a 4-point descriptive scale
Measured: 56 days
Compare blood inflammatory markers between the ARINA-1 and placebo arms
C-reactive protein
Measured: 56 days
Compare changes in mucolytic use between ARINA-1 and placebo arms
Compare the initiation or changes to regimen for drugs such as n-acetylcysteine, dornase alfa, etc. This information will be collected at all clinic visits and phone calls.
Measured: 56 days
Compare changes in airway clearance techniques between ARINA-1 and placebo arms
Compare the initiation or changes to regimen for airway clearance techniques such as chest physical therapy, high-frequency oscillating vest therapy, etc. This information will be collected at all clinic visits and phone calls.
Measured: 56 days
Compare FEV1 between the ARINA-1 and treatment arms
measured in L
Measured: 56 days
Compare FVC between the ARINA-1 and treatment arms
measured in L
Measured: 56 days
Compare FEF25-75 between the ARINA-1 and treatment arms
measured in L/sec
Measured: 56 days
Compare PEF between the ARINA-1 and treatment arms
measured in L/min
Measured: 56 days
Compare sputum percent solids between the ARINA-1 and placebo arms
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start3 Oct 2022
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cystic Fibrosis BronchiectasisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renovion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles L Daley, MD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495243
- Sponsor's protocol ID
- RVN-301
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2022
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ARINA-1 in Adult Participants With Non-cystic Fibrosis Bronchiectasis (NCFBE) With Excess Mucus and Cough
- ClinicalTrials.gov ID
- NCT05495243
- Acronym / sponsor ID
- RVN-301
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Keywords
- bronchiectasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Renovion, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 10 Aug 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.
This is a randomized, Phase 2a, double-blind, placebo-controlled study to evaluate the safety and efficacy of ARINA-1 compared to placebo (isotonic saline, 0.9%) in participants with NCFBE. Study participants will receive either study treatment or placebo twice daily for 28 days. Efficacy endpoints will include quality of life, sputum rheological markers, and blood inflammatory markers. Quality of life will be measured using the following tools: Quality of Life-Bronchiectasis (QOL-B) questionnaire, St. George's Respiratory Questionnaire (SGRQ), Chronic Airways Assessment Test (CAAT), and a daily clinical global impression questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARINA-1 | Experimental | Drug: ARINA-1ARINA-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 |
| Placebo | Placebo comparator | Drug: PlaceboIsotonic saline (0.9%); 4 mL solution inhaled twice daily via nebulization for 28 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of NCFBE confirmed by chest CT
- 18-80 years old, inclusive at time of informed consent
- BMI >18
- Percent predicted FEV1 > 40%, pre-bronchodilator
- Stable for 90 days with any airway clearance technique (ACT) method(s)
Key exclusion criteria (11 listed)
- Positive urine pregnancy test for women of childbearing potential (WOCBP) at screening and baseline visit
- Active exacerbation ≤28 days prior to the baseline visit
- Initiating or changing antibiotic, antiviral, or antifungal therapy ≤ 28 days prior to the baseline visit
- Changing or initiating any vitamin C, glutathione or N-acetyl-cysteine-containing therapy or multivitamin within 30 says prior to the screening visit.
- Positive COVID-19 diagnostic test (PCR or antigen) within 90 days prior to the screening visit.
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-1ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH) | Drug | ARINA-1 |
| PlaceboIsotonic saline (0.9%) | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: 56 days
Incidence of participants that experience an adverse event following administration of treatment
Proportion of participants that experience each treatment-emergent adverse event
Time frame: 56 days
11 secondary outcomes
Compare quality of life (as measured by CAAT questionnaire) between the ARINA-1 and placebo arms
Time frame: 56 days
Compare quality of life (as measured by SGRQ) between the ARINA-1 and placebo arms
Time frame: 56 days
Compare quality of life (as measured by QOL-B) between the ARINA-1 and placebo arms
Time frame: 56 days
Compare blood inflammatory markers between the ARINA-1 and placebo arms
Time frame: 56 days
Compare changes in mucolytic use between ARINA-1 and placebo arms
Time frame: 56 days
Compare changes in airway clearance techniques between ARINA-1 and placebo arms
Time frame: 56 days
Compare FEV1 between the ARINA-1 and treatment arms
Time frame: 56 days
Compare FVC between the ARINA-1 and treatment arms
Time frame: 56 days
Compare FEF25-75 between the ARINA-1 and treatment arms
Time frame: 56 days
Compare PEF between the ARINA-1 and treatment arms
Time frame: 56 days
Compare sputum percent solids between the ARINA-1 and placebo arms
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- 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.
Charles L Daley, MD principal investigator
National Jewish Health
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARINA-1 in people with Non-cystic Fibrosis Bronchiectasis, run by Renovion, Inc. at 10 sites 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 9 inclusion and 11 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: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 treatment-emergent adverse events (time frame: 56 days). The study lists 2 primary outcomes in all. 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 23 Jul 2025.