Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant
Start Date
4/10/2023
Completion Date
11/1/2026
Summary
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.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
ARINA-1
Standard of care only
Conditions
Locations
Dignity Health - St. Joseph's Hospital and Medical Center
Phoenix, Arizona 85013
United States
University of California Los Angeles School of Medicine
Los Angeles, California 90095
United States
University of California San Diego Health
San Diego, California 92103
United States
Advent Health
Orlando, Florida 32803
United States
University of South Florida
Tampa, Florida 33606
United States
Loyola University Medical Center
Maywood, Illinois 60153
United States
University of Iowa Hospital
Iowa City, Iowa 52242
United States
Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
University of Minnesota Medical School
Minneapolis, Minnesota 55455
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Columbia University Irving Medical Center
New York, New York 10032
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio 43221
United States
Temple University Hospital
Philadelphia, Pennsylvania 19122
United States
Medical University of South Carolina
Charleston, South Carolina 29452
United States
University of Texas Southwestern Medical Center
Dallas, Texas 45390
United States
Baylor Scott and White Research Institute
Dallas, Texas 75246
United States
Baylor St. Luke's Medical Center
Houston, Texas 77030
United States
Houston Methodist Hospital
Houston, Texas 77030
United States
Inova Fairfax Hospital
Falls Church, Virginia 22042
United States