Status:
TERMINATED
KL₄Surfactant Treatment in Patients With ARDS
Lead Sponsor:
Windtree Therapeutics
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
16-75 years
Phase:
PHASE2
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 ...
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 bronchos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00215553
Start Date
May 1 2001
End Date
February 1 2006
Last Update
August 9 2018
Active Locations (1)
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1
Discovery Laboratories, Inc.
Warrington, Pennsylvania, United States, 18976-3646