KL₄Surfactant Treatment in Patients With ARDS

A Multicenter, Randomized, Controlled Trial Comparing the Safety and Effectiveness of SURFAXIN® (Lucinactant) Delivered Via Bronchopulmonary Segmental Lavage to Standard of Care in Patients With Acute Respiratory Distress Syndrome (ARDS).

Lung wash with KL₄Surfactant of individual lung segments using a bronchoscope compared to usual care alone consisting primarily of assisted (mechanical) ventilation in patients with acute respiratory distress syndrome(ARDS).

This is a multinational, multicenter, two-part, Phase 2 study that will evaluate the tolerability, safety, and efficacy of KL₄Surfactant in adult ARDS patients when administered by sequential bronchoscopic lavage into each of the 19 bronchopulmonary segments of the lung and as a bolus instillation into each lung.

Inclusion Criteria:

• Intubated and required mechanical ventilation support
• Met the criteria for ARDS
• Partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ≤ 200 mmHg and ≥ 60 mmHg within 60 minutes before randomization
• Mean blood pressure was ≥ 60 mmHg immediately before randomization

Exclusion Criteria:

• Had ARDS due solely to a major trauma
• Was currently participating in another clinical trial or received an experimental drug or device within the previous month
• A woman of childbearing age, unless pregnancy was excluded by a negative urine hCG test or if the subject was surgically incapable of childbearing
• Had a previous episode of ARDS that resolved and then recurred during the current hospitalization
• Had a disease that was sufficiently advanced, in the best judgment of the Principal Investigator, to markedly limit life expectancy to < 6 months
• Was known to have AIDS or symptomatic HIV (CD4 counts <500). Subjects with asymptomatic HIV were not excluded
• Received chemotherapy or radiation within the previous 90 days
• Received an organ transplant other than corneal transplants
• Received, or was currently receiving, immunosuppression therapy within the last 6 months
• Had severe neurological damage or the presence of a disease that was likely to significantly prevent weaning from the ventilator
• Had a best Glasgow Coma Score (GCS) of ≤ 8 or an intracranial pressure ≥ 20 cm H2O prior to the institution of sedatives or paralysis