KL₄Surfactant Treatment in Patients With ARDS

NCT ID: NCT00215553

Last Updated: 2018-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2006-02-28

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).

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.

Conditions

Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

A.1 Lucinactant

Intervention Type: DRUG

3 30 mL aliquots at concentrations of 5, 5, and 10 mg/mL

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.

Group Type: EXPERIMENTAL

A.2 Lucinactant

Intervention Type: DRUG

3 30 mL aliquots at a concentration of 10 mg/mL each

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.

Group Type: EXPERIMENTAL

A.3 Lucinactant

Intervention Type: DRUG

2 50 mL aliquots at concentrations of 10 and 20 mg/mL

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.

Group Type: EXPERIMENTAL

A.4 Lucinactant

Intervention Type: DRUG

2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed

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.

Group Type: EXPERIMENTAL

B.1 Lucinactant

Intervention Type: DRUG

2 50 mL aliquots at concentrations of 10 and 20 mg/mL

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.

Group Type: EXPERIMENTAL

B.2 Lucinactant

Intervention Type: DRUG

2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed

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.

Group Type: OTHER

B.3 SoC

Intervention Type: OTHER

Standard ARDS management and ICU care

Interventions

A.1 Lucinactant

3 30 mL aliquots at concentrations of 5, 5, and 10 mg/mL

Intervention Type: DRUG

B.3 SoC

Standard ARDS management and ICU care

Intervention Type: OTHER

A.2 Lucinactant

3 30 mL aliquots at a concentration of 10 mg/mL each

Intervention Type: DRUG

A.3 Lucinactant

2 50 mL aliquots at concentrations of 10 and 20 mg/mL

Intervention Type: DRUG

A.4 Lucinactant

2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed

Intervention Type: DRUG

B.1 Lucinactant

2 50 mL aliquots at concentrations of 10 and 20 mg/mL

Intervention Type: DRUG

B.2 Lucinactant

2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed

Intervention Type: DRUG

Other Intervention Names

KL₄Surfactant; Negative control; KL₄Surfactant; KL₄Surfactant; KL₄Surfactant; KL₄Surfactant; KL₄Surfactant

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Windtree Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy J Gregory, PhD

Role: STUDY_DIRECTOR

Windtree Therapeutics

Locations

Discovery Laboratories, Inc.

Warrington, Pennsylvania, United States

Countries

United States

Other Identifiers

KL4-ARDS-04

Identifier Type: -

Identifier Source: org_study_id