KL₄Surfactant Treatment in Patients With ARDS

• ClinicalTrials.gov Identifier: NCT00215553
• Recruitment Status: Terminated
• First Posted: September 22, 2005
• Results First Posted: April 27, 2012
• Last Update Posted: August 9, 2018
• Sponsor: Windtree Therapeutics
• Information provided by (Responsible Party): Windtree Therapeutics

Study Description

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 distress syndrome(ARDS).

Condition or disease	Intervention/treatment	Phase
Acute Respiratory Distress Syndrome	Drug: A.1 Lucinactant; Other: B.3 SoC; Drug: A.2 Lucinactant; Drug: A.3 Lucinactant; Drug: A.4 Lucinactant; Drug: B.1 Lucinactant; Drug: B.2 Lucinactant	Phase 2

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 bronchoscopic lavage into each of the 19 bronchopulmonary segments of the lung and as a bolus instillation into each lung.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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).
• Study Start Date: May 2001
• Actual Primary Completion Date: February 2006
• Actual Study Completion Date: February 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: A.1 Lucinactant; 3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.	Drug: A.1 Lucinactant; 3 30 mL aliquots at concentrations of 5, 5, and 10 mg/mL; Other Name: KL₄Surfactant
Experimental: A.2 Lucinactant; 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.	Drug: A.2 Lucinactant; 3 30 mL aliquots at a concentration of 10 mg/mL each; Other Name: KL₄Surfactant
Experimental: A.3 Lucinactant; 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.	Drug: A.3 Lucinactant; 2 50 mL aliquots at concentrations of 10 and 20 mg/mL; Other Name: KL₄Surfactant
Experimental: A.4 Lucinactant; 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.	Drug: A.4 Lucinactant; 2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed; Other Name: KL₄Surfactant
Experimental: B.1 Lucinactant; 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.	Drug: B.1 Lucinactant; 2 50 mL aliquots at concentrations of 10 and 20 mg/mL; Other Name: KL₄Surfactant
Experimental: B.2 Lucinactant; 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.	Drug: B.2 Lucinactant; 2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed; Other Name: KL₄Surfactant
B.3 SoC; 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.	Other: B.3 SoC; Standard ARDS management and ICU care; Other Name: Negative control

Outcome Measures

Primary Outcome Measures :

1. Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28. [ Time Frame: Through 28 days ]

Secondary Outcome Measures :

1. Mortality [ Time Frame: Through 28 days ]
2. Days in ICU [ Time Frame: Through 28 days ]
   Number of days in ICU

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 75 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Pennsylvania

Discovery Laboratories, Inc.

Warrington, Pennsylvania, United States, 18976-3646

Sponsors and Collaborators

Windtree Therapeutics

Investigators

• Study Director: Timothy J Gregory, PhD; Windtree Therapeutics

More Information

• Responsible Party: Windtree Therapeutics
• ClinicalTrials.gov Identifier: NCT00215553
• Other Study ID Numbers: KL4-ARDS-04
• First Posted: September 22, 2005
• Results First Posted: April 27, 2012
• Last Update Posted: August 9, 2018
• Last Verified: July 2018

Additional relevant MeSH terms:

Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome; Disease; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Pulmonary Surfactants; Respiratory System Agents