KL₄Surfactant Treatment in Patients With ARDS

NCT00215553 | Terminated Phase 2 Results DMC

• 1 other identifier: KL4-ARDS-04
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.

  Through 28 days

Secondary Outcomes (2)

• Mortality

  Through 28 days

• Days in ICU

  Through 28 days

Study Arms (7)

A.1 Lucinactant

EXPERIMENTAL

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

A.2 Lucinactant

EXPERIMENTAL

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

A.3 Lucinactant

EXPERIMENTAL

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

A.4 Lucinactant

EXPERIMENTAL

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

B.1 Lucinactant

EXPERIMENTAL

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

B.2 Lucinactant

EXPERIMENTAL

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

B.3 SoC

OTHER

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

Interventions

A.1 Lucinactant DRUG

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

Also known as: KL₄Surfactant

A.1 Lucinactant

B.3 SoC OTHER

Standard ARDS management and ICU care

Also known as: Negative control

B.3 SoC

A.2 Lucinactant DRUG

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

Also known as: KL₄Surfactant

A.2 Lucinactant

A.3 Lucinactant DRUG

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

Also known as: KL₄Surfactant

A.3 Lucinactant

A.4 Lucinactant DRUG

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

Also known as: KL₄Surfactant

A.4 Lucinactant

B.1 Lucinactant DRUG

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

Also known as: KL₄Surfactant

B.1 Lucinactant

B.2 Lucinactant DRUG

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

Also known as: KL₄Surfactant

B.2 Lucinactant

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Windtree Therapeutics: lead

Study Sites (1)

Discovery Laboratories, Inc.

Warrington, Pennsylvania, 18976-3646, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Results Point of Contact

• Title: Robert Segal, MD
• Organization: Discovery Laboratories, Inc.

rsegal@discoverylabs.com

215-488-9300

Study Officials

• Timothy J Gregory, PhD

  Windtree Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: May 1, 2001
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: August 9, 2018
• Results First Posted: April 27, 2012

Record last verified: 2018-07

Locations

US (1)