A Phase 3 interventional study of ARINA-1 and Standard of care only in Pre-Bronchiolitis Obliterans Syndrome, sponsored by Renovion, Inc.. Recruiting at 22 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Renovion, Inc. · Phase 3, Interventional, and Treatment
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:
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.
Renovion, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: ARINA-1
Standard 3-therapy immunosuppression regimen and azithromycin
Other: Standard of care only
ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH)
Standard 3-therapy immunosuppression regimen and azithromycin
Percentage change from baseline in FEV1 (%ΔFEV1)
Week 24 (mL) - Baseline (mL) = ΔFEV1 (mL) ΔFEV1 (mL) / Baseline (mL) x 100 = %ΔFEV1
Time frame: 24 weeks
Percentage change from baseline of Forced Expiratory Volume in one second (FEV1)
Week 48 (mL) - Baseline (mL) = ΔFEV1 (mL) ΔFEV1 (mL) / Baseline (mL) x 100 = %ΔFEV1
Time frame: 48 weeks
Percentage change from baseline of Forced Vital Capacity (FVC)
Time frame: 24 weeks
Percentage change from baseline of FVC
Time frame: 48 weeks
Percentage change from baseline of FEF25-75%
Time frame: 24 weeks
Percentage change from baseline of FEF25-75%
Time frame: 48 weeks
Number of participants in each arm with augmented immunosuppression
number
Time frame: 24 weeks
Number of participants in each arm with augmented immunosuppression
Time frame: 48 weeks
Time to initiation of augmented immunosuppression
Length of time to when participant requires a change in their immunosuppression regimen
Time frame: over the duration of the 48 week trial
Change from baseline in Saint George's Respiratory Questionnaire total score
quality of life questionnaire, total score of 0 to 100, higher score = more limitations
Time frame: 24 weeks
Change from baseline in Saint George's Respiratory Questionnaire total score
quality of life questionnaire, total score of 0 to 100, higher score = more limitations
Time frame: 48 weeks
Proportion of participants requiring the use of antimicrobial agents to treat a pulmonary infection
Time frame: 48 weeks
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Renovion, Inc.