KL₄Surfactant Treatment in Patients With ARDS

Stopped early · Phase 2

Conditions studied: Acute Respiratory Distress Syndrome

In brief

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).

Key facts

Study ID

NCT00215553

Run by

Windtree Therapeutics

People needed

124

Starts

2001-05-01

Expected to finish

2006-02-01

Last updated by the study team

2018-08-09

Who can join

Age: 16 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Discovery Laboratories, Inc. — Warrington, Pennsylvania, United States

Full record on ClinicalTrials.gov

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