RVN-001 A Phase 3, Open-Label, Randomized, Standard of Care- Controlled, Parallel Arm Study to Demonstrate Efficacy and Safety of ARINA-1 in the Prevention of Bronchiolitis Obliterans Syndrome Progression in Participants with Bilateral Lung Transplant

NCT05654922

A Phase 3, Open-Label, Randomized, Standard of Care- Controlled, Parallel Arm Study to Demonstrate Efficacy and Safety of ARINA-1 in the Prevention of Bronchiolitis Obliterans Syndrome Progression in Participants with Bilateral Lung Transplant

Principal Investigator

Onix CantresFonseca

Sponsor

Renovion, Inc.

The purpose of this research study is to see if the investigational drug, ARINA-1 when used with the investigational PARI eFlow nebulizer system, can stabilize or improve the lung function of participants who have had a bilateral lung transplant and are experiencing an unexplained decrease in their volume that has been exhaled at the end of the first second of forced expiration (FEV1). ARINA-1 is considered an investigational drug. An investigational drug is one that is still being tested in research studies and is not yet approved by the U.S. Food and Drug Administration (FDA) for the treatment of your condition.

This study is currently enrolling.