Expired Study
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Warrington, Pennsylvania 18976


Purpose:

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).


Study summary:

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.


Criteria:

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


NCT ID:

NCT00215553


Primary Contact:

Study Director
Timothy J Gregory, PhD
Windtree Therapeutics


Backup Contact:

N/A


Location Contact:

Warrington, Pennsylvania 18976
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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