NCT00215553

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).

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Windtree Therapeutics · Industry
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	A.1 Lucinactant	3 30 mL aliquots at concentrations of 5, 5, and 10 mg/mL
OTHER	B.3 SoC	Standard ARDS management and ICU care
DRUG	A.2 Lucinactant	3 30 mL aliquots at a concentration of 10 mg/mL each
DRUG	A.3 Lucinactant	2 50 mL aliquots at concentrations of 10 and 20 mg/mL
DRUG	A.4 Lucinactant	2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed
DRUG	B.1 Lucinactant	2 50 mL aliquots at concentrations of 10 and 20 mg/mL
DRUG	B.2 Lucinactant	2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed

Timeline

• Start date: 2001-05-01
• Primary completion: 2006-02-01
• Completion: 2006-02-01
• First posted: 2005-09-22
• Last updated: 2018-08-09
• Results posted: 2012-04-27

Locations

1 site across 1 country: United States