KL₄Surfactant Treatment in Patients With ARDS

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

A Multicenter, Randomized, Controlled Trial Comparing the Safety and Effectiveness of SURFAXIN® (Lucinactant) Delivered Via Bronchopulmonary Segmental Lavage to Standard of Care in Patients With Acute Respiratory Distress Syndrome (ARDS).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00215553
• Other study ID #: KL4-ARDS-04
• Status: Terminated
• Phase: Phase 2
• Start date: May 2001
• Est. completion date: February 2006

Study information

• Verified date: July 2018
• Source: Windtree Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Terminated
• Enrollment: 124
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• A.1 Lucinactant
3 30 mL aliquots at concentrations of 5, 5, and 10 mg/mL

Other:
• B.3 SoC
Standard ARDS management and ICU care

Drug:
• A.2 Lucinactant
3 30 mL aliquots at a concentration of 10 mg/mL each
• A.3 Lucinactant
2 50 mL aliquots at concentrations of 10 and 20 mg/mL
• A.4 Lucinactant
2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed
• B.1 Lucinactant
2 50 mL aliquots at concentrations of 10 and 20 mg/mL
• B.2 Lucinactant
2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed

Locations

Country	Name	City	State
United States	Discovery Laboratories, Inc.	Warrington	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Windtree Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for =48 Hours at the End of Day 28.		Through 28 days
Secondary	Mortality		Through 28 days
Secondary	Days in ICU	Number of days in ICU	Through 28 days