Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant

Conditions

• Pre-Bronchiolitis Obliterans Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• ARINA-1 — DRUG
  ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH)
• Standard of care only — OTHER
  Standard 3-therapy immunosuppression regimen and azithromycin

Study Details

The goal of this Phase 3 clinical trial is to compare ARINA-1 (a nebulized immunomodulatory agent) plus Standard of Care vs Standard of Care alone. The main question it aims to answer are: * Evaluate the effectiveness of ARINA-1 in preventing bronchiolitis obliterans syndrome (BOS) progression in participants with a bilateral lung transplant * To evaluate the effectiveness of ARINA-1 on improving quality of life decline and preventing or delaying the use of augmented immunosuppression in participants with pre-BOS relative to SOC. Participants will have clinic visits at screening, randomization (day 1) and weeks 4, 12, 18, and 24. After week 24, participants will have clinic visits at weeks 32, 40, and 48. Participants will also have a telehealth visit on day 2 and phone calls to assess adverse events (AEs), serious adverse events (SAEs), and review patient education will occur during weeks 5, 8, 36, and 44.

Key Dates

First listed

Dec 16, 2022

Start date

Apr 10, 2023

Status verified

Aug 2026

Primary completion

Feb 29, 2028

Completion

Aug 31, 2028

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ARINA-1 plus standard of care
  ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH); fixed dose, 4 mL solution inhaled twice daily via nebulization plus standard 3-therapy immunosuppression regimen and azithromycin
• Other: Standard of care only
  Standard 3-therapy immunosuppression regimen and azithromycin

Primary Outcome Measure

Percentage change from baseline in FEV1 (%ΔFEV1) [ Time Frame: 24 weeks ]

Central Contacts

• Carolyn Durham, PhD
  919-240-7034
  [email protected]
• Will Anderson
  919-240-7034
  [email protected]

Locations (22)

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