KL₄Surfactant Treatment in Patients With ARDS
Status and phase
Terminated
Phase 2
Conditions
Acute Respiratory Distress Syndrome
Treatments
Other: B.3 SoC
Drug: B.2 Lucinactant
Drug: A.2 Lucinactant
Drug: B.1 Lucinactant
Drug: A.4 Lucinactant
Drug: A.3 Lucinactant
Drug: A.1 Lucinactant
Details and patient eligibility
About
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).
Full 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.
Enrollment
124 patients
Sex
All
Ages
16 to 75 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
124 participants in 7 patient groups
A.1 Lucinactant
Experimental group
Description:
3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
Treatment:
Drug: A.1 Lucinactant
A.2 Lucinactant
Experimental group
Description:
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.
Treatment:
Drug: A.2 Lucinactant
A.3 Lucinactant
Experimental group
Description:
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
Treatment:
Drug: A.3 Lucinactant
A.4 Lucinactant
Experimental group
Description:
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.
Treatment:
Drug: A.4 Lucinactant
B.1 Lucinactant
Experimental group
Description:
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
Treatment:
Drug: B.1 Lucinactant
B.2 Lucinactant
Experimental group
Description:
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.
Treatment:
Drug: B.2 Lucinactant
B.3 SoC
Other group
Description:
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.
Treatment:
Other: B.3 SoC
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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