LARMA Study Synopsis
A Phase II/III Randomized, Double-Blind, Placebo-Controlled Trial of Lisofylline in Patients with Acute Lung Injury and Adult Respiratory Distress Syndrome (LARMA)
This study was a randomized, double-blind, placebo- controlled multi-center 2 x 2 factorial study. Each patient is randomized between Lisofylline and Placebo.
This study was designed to test whether the administration of lisofylline early after the onset of ALI or ARDS would reduce mortality and morbidity. The study was stopped by the Data and Safety Monitoring Board (DSMB) for futility at the first scheduled interim analysis. The decision was based on predetermined criteria, which required a positive trend toward improvement in day 28 survival among the LSF recipients for the trial to continue as a phase III trial. The results of this study were published in January 2001 (The ARDS Clinical Trials Network; National Heart, Lung and Blood Institute; National Institutes of Health. Randomized, placebo-controlled trial of lisofylline for early treatment of acute lung injury and acute respiratory distress syndrome. Crit Care Med. 2002; 30(1):1-6).