Conditions: Acute Respiratory Distress Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 124
Healthy volunteers: no

Brief summary:
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).

Detailed description:
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.

Arms:
arm 1: 3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours. arm 2: 3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours. arm 3: 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. arm 4: 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later. arm 5: 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. arm 6: 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later. arm 7: Received standard ARDS management and ICU care (Standard of Care \[SOC\]). Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.

Interventions: intervention 1: A.1 Lucinactant intervention 2: B.3 SoC intervention 3: A.2 Lucinactant intervention 4: A.3 Lucinactant intervention 5: A.4 Lucinactant intervention 6: B.1 Lucinactant intervention 7: B.2 Lucinactant
Intervention descriptions: intervention 1: 3 30 mL aliquots at concentrations of 5, 5, and 10 mg/mL intervention 2: Standard ARDS management and ICU care intervention 3: 3 30 mL aliquots at a concentration of 10 mg/mL each intervention 4: 2 50 mL aliquots at concentrations of 10 and 20 mg/mL intervention 5: 2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed intervention 6: 2 50 mL aliquots at concentrations of 10 and 20 mg/mL intervention 7: 2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed

Protocol document: