Phase III Randomized Trial Evaluating Inhaled Aprotinin Versus Placebo for Moderate to Severe Acute Respiratory Distress Syndrome

What this Trial Is About

Researchers are conducting a multicenter, double-blind, placebo-controlled Phase III clinical trial to evaluate inhaled aprotinin in adults with moderate or severe acute respiratory distress syndrome ARDS. ARDS is a serious lung condition causing inflammation, fluid buildup, and severe breathing failure. Despite current supportive care, no specific drug treatment has shown clear benefit, so this study aims to assess if inhaled aprotinin can improve patient outcomes. In this trial, 156 critically ill patients in intensive care units will be randomly assigned to receive either inhaled aprotinin or a placebo, alongside standard supportive treatments. Aprotinin will be given by nebulization through breathing tubes, four times daily at a dose of 500 KIU every six hours for six days. The placebo group will follow an identical schedule. The study uses a double-blind design to keep participants and researchers unaware of group assignments. Participants will be closely monitored during their ICU and hospital stay with regular assessments of breathing, organ function, and inflammation markers. The main measurement is the number of days patients are free from mechanical ventilation within 28 days after treatment starts. Secondary outcomes include survival rates, time spent in ICU or hospital, kidney and heart support needs, and biomarker levels. Safety will be overseen by an independent committee, and follow-up will continue up to 180 days after treatment.

Clinical Trial With Aprotinin in the Acute Respiratory Distress Syndrome Treatment