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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
3 30 mL aliquots at concentrations of 5, 5, and 10 mg/mL
Standard ARDS management and ICU care
3 30 mL aliquots at a concentration of 10 mg/mL each
Discovery Laboratories, Inc.
Warrington, Pennsylvania, United States
Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.
Time frame: Through 28 days
Mortality
Time frame: Through 28 days
Days in ICU
Number of days in ICU
Time frame: Through 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
2 50 mL aliquots at concentrations of 10 and 20 mg/mL
2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed
2 50 mL aliquots at concentrations of 10 and 20 mg/mL
2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed