Phase 2a, 28-day Investigational Use Study of ARINA-1 in Non-Cystic Fibrosis Bronchiectasis (NCFBE) With Excess Mucus and Cough

NCT05495243 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: RVN-301
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 10

Brief 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. 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

Keywords

bronchiectasis

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-emergent adverse events

  Incidence of participants that experience an adverse event following administration of treatment

  56 days

• Proportion of participants that experience each treatment-emergent adverse event

  56 days

Secondary Outcomes (11)

• Compare quality of life (as measured by CAAT questionnaire) between the ARINA-1 and placebo arms

  56 days

• Compare quality of life (as measured by SGRQ) between the ARINA-1 and placebo arms

  56 days

• Compare quality of life (as measured by QOL-B) between the ARINA-1 and placebo arms

  56 days

• Compare blood inflammatory markers between the ARINA-1 and placebo arms

  56 days

• Compare changes in mucolytic use between ARINA-1 and placebo arms

  56 days

Study Arms (2)

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

Drug: ARINA-1

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

ARINA-1 DRUG

ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH)

ARINA-1

Placebo DRUG

Isotonic saline (0.9%)

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of NCFBE confirmed by chest CT
• 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
• 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.

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Renovion, Inc.: lead

Study Sites (10)

University of Alabama - Birmingham

Birmingham, Alabama, 35294, United States

Location

National Jewish Hospital

Denver, Colorado, 80206, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Louisiana State University

New Orleans, Louisiana, 70803, United States

Location

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Jefferson Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas - Tyler

Tyler, Texas, 29425, United States

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Charles L Daley, MD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: August 10, 2022
• Study Start: October 3, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)