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

NCT ID: NCT05495243

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-03
• Study Completion Date: 2024-02-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ARINA-1

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 Type: EXPERIMENTAL

ARINA-1

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Isotonic saline (0.9%)

Interventions

ARINA-1

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

Intervention Type: DRUG

Placebo

Isotonic saline (0.9%)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renovion, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles L Daley, MD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Locations

University of Alabama - Birmingham

Birmingham, Alabama, United States

National Jewish Hospital

Denver, Colorado, United States

Georgetown University

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

Louisiana State University

New Orleans, Louisiana, United States

Johns Hopkins

Baltimore, Maryland, United States

Southeastern Research Center

Winston-Salem, North Carolina, United States

Oregon Health and Science University

Portland, Oregon, United States

Jefferson Hospital

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas - Tyler

Tyler, Texas, United States

Countries

United States

Other Identifiers

RVN-301

Identifier Type: -

Identifier Source: org_study_id