FDAnews
www.fdanews.com/articles/85713-discovery-labs-announces-preliminary-results-of-ards-trial

DISCOVERY LABS ANNOUNCES PRELIMINARY RESULTS OF ARDS TRIAL

March 31, 2006

Discovery Laboratories have announced preliminary results from its recently completed Phase II clinical trial for the treatment of acute respiratory distress syndrome (ARDS) in adults using the company's precision-engineered surfactant delivered via bronchoscopic segmental lavage (Surfactant Lavage).

The trial was an open-label, controlled, multicenter, international study of Surfactant Lavage for the treatment of ARDS in adults. Patients were randomized to receive either surfactant administered in high concentrations and large volumes via a bronchoscopic segmental lavage technique (lung wash), or the current standard of care (SOC), which is mechanical ventilation and other supportive therapies. Surfactant was delivered with a bronchoscope to each of the 19 segments of the lung and was intended to cleanse and remove inflammatory substances and debris from the lung, while leaving sufficient amounts of surfactant behind to help re-establish the lung's capacity to absorb oxygen.