KL₄Surfactant Treatment in Patients With ARDS
Phase 2
Terminated
- Conditions
- Acute Respiratory Distress Syndrome
- Interventions
- Registration Number
- NCT00215553
- Lead Sponsor
- Windtree Therapeutics
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 124
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A.1 Lucinactant A.1 Lucinactant 3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours. A.4 Lucinactant A.4 Lucinactant 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. B.1 Lucinactant B.1 Lucinactant 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. A.2 Lucinactant A.2 Lucinactant 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. B.3 SoC B.3 SoC 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. A.3 Lucinactant A.3 Lucinactant 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. B.2 Lucinactant B.2 Lucinactant 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.
- Primary Outcome Measures
Name Time Method Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28. Through 28 days
- Secondary Outcome Measures
Name Time Method Days in ICU Through 28 days Number of days in ICU
Mortality Through 28 days
Trial Locations
- Locations (1)
Discovery Laboratories, Inc.
🇺🇸Warrington, Pennsylvania, United States