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KL₄Surfactant Treatment in Patients With ARDS

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ClinicalTrials.gov Identifier: NCT00215553
Recruitment Status : Terminated (Slow enrollment and administrative reasons)
First Posted : September 22, 2005
Results First Posted : April 27, 2012
Last Update Posted : April 27, 2012
Sponsor:
Information provided by (Responsible Party):
Windtree Therapeutics

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: Lucinactant Other: Standard of Care 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 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
Primary Completion Date : February 2006
Study Completion Date : February 2006


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: Lucinactant
Suspension for instillation
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: Lucinactant
Suspension for instillation
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: Lucinactant
Suspension for instillation
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: Lucinactant
Suspension for instillation
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: Lucinactant
Suspension for instillation
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: Lucinactant
Suspension for instillation
Other Name: KL₄Surfactant
B.3 SoC
Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
Other: Standard of Care
Standard ARDS management and ICU care
Other Name: Negative control



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: 28 days ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: Day 28 ]
  2. Days in ICU [ Time Frame: Day 28 ]
    Number of days in ICU



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

Inclusion Criteria:

  • Intubated and required mechanical ventilation support
  • Met the criteria for ARDS
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215553


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

Responsible Party: Windtree Therapeutics
ClinicalTrials.gov Identifier: NCT00215553     History of Changes
Other Study ID Numbers: KL4-ARDS-04
First Posted: September 22, 2005    Key Record Dates
Results First Posted: April 27, 2012
Last Update Posted: April 27, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Pulmonary Surfactants
Respiratory System Agents