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KL₄Surfactant Treatment in Patients With ARDS

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
A.1 Lucinactant
B.3 SoC
A.2 Lucinactant
A.3 Lucinactant
A.4 Lucinactant
B.1 Lucinactant
B.2 Lucinactant
Sponsored by
Windtree Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Discovery Laboratories, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Other

Arm Label

A.1 Lucinactant

A.2 Lucinactant

A.3 Lucinactant

A.4 Lucinactant

B.1 Lucinactant

B.2 Lucinactant

B.3 SoC

Arm Description

3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.

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.

2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.

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.

2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mortality
Days in ICU
Number of days in ICU

Full Information

First Posted
September 14, 2005
Last Updated
July 12, 2018
Sponsor
Windtree Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00215553
Brief Title
KL₄Surfactant Treatment in Patients With ARDS
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 Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment and administrative reasons
Study Start Date
May 2001 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Windtree Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A.1 Lucinactant
Arm Type
Experimental
Arm Description
3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
Arm Title
A.2 Lucinactant
Arm Type
Experimental
Arm Description
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.
Arm Title
A.3 Lucinactant
Arm Type
Experimental
Arm Description
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
Arm Title
A.4 Lucinactant
Arm Type
Experimental
Arm Description
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.
Arm Title
B.1 Lucinactant
Arm Type
Experimental
Arm Description
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
Arm Title
B.2 Lucinactant
Arm Type
Experimental
Arm Description
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.
Arm Title
B.3 SoC
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
A.1 Lucinactant
Other Intervention Name(s)
KL₄Surfactant
Intervention Description
3 30 mL aliquots at concentrations of 5, 5, and 10 mg/mL
Intervention Type
Other
Intervention Name(s)
B.3 SoC
Other Intervention Name(s)
Negative control
Intervention Description
Standard ARDS management and ICU care
Intervention Type
Drug
Intervention Name(s)
A.2 Lucinactant
Other Intervention Name(s)
KL₄Surfactant
Intervention Description
3 30 mL aliquots at a concentration of 10 mg/mL each
Intervention Type
Drug
Intervention Name(s)
A.3 Lucinactant
Other Intervention Name(s)
KL₄Surfactant
Intervention Description
2 50 mL aliquots at concentrations of 10 and 20 mg/mL
Intervention Type
Drug
Intervention Name(s)
A.4 Lucinactant
Other Intervention Name(s)
KL₄Surfactant
Intervention Description
2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed
Intervention Type
Drug
Intervention Name(s)
B.1 Lucinactant
Other Intervention Name(s)
KL₄Surfactant
Intervention Description
2 50 mL aliquots at concentrations of 10 and 20 mg/mL
Intervention Type
Drug
Intervention Name(s)
B.2 Lucinactant
Other Intervention Name(s)
KL₄Surfactant
Intervention Description
2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Mortality
Time Frame
Through 28 days
Title
Days in ICU
Description
Number of days in ICU
Time Frame
Through 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy J Gregory, PhD
Organizational Affiliation
Windtree Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Discovery Laboratories, Inc.
City
Warrington
State/Province
Pennsylvania
ZIP/Postal Code
18976-3646
Country
United States

12. IPD Sharing Statement

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KL₄Surfactant Treatment in Patients With ARDS

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