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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH)
Standard 3-therapy immunosuppression regimen and azithromycin
Dignity Health - St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
WITHDRAWNUniversity of California Los Angeles School of Medicine
Los Angeles, California, United States
RECRUITINGUniversity of California San Diego Health
San Diego, California, United States
RECRUITINGAdvent Health
Orlando, Florida, United States
RECRUITINGUniversity of South Florida
Tampa, Florida, United States
RECRUITINGLoyola University Medical Center
Maywood, Illinois, United States
RECRUITINGUniversity of Iowa Hospital
Iowa City, Iowa, United States
RECRUITINGJohns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGUniversity of Minnesota Medical School
Minneapolis, Minnesota, United States
WITHDRAWNWashington University School of Medicine
St Louis, Missouri, United States
RECRUITING...and 10 more locations
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
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