KL₄Surfactant Treatment in Patients With ARDS - Full Text View

Purpose

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	Intervention	Phase
Acute Respiratory Distress Syndrome	Drug: Lucinactant Other: Standard of Care	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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).

Resource links provided by NLM:

Drug Information available for: Sinapultide Lucinactant

U.S. FDA Resources

Further study details as provided by Discovery Laboratories:

Primary Outcome Measures:

Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mortality [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
Days in ICU [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
Number of days in ICU

Enrollment:	124
Study Start Date:	May 2001
Study Completion Date:	February 2006
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	16 Years to 75 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215553

Locations

United States, Pennsylvania
Discovery Laboratories, Inc.
Warrington, Pennsylvania, United States, 18976-3646

Sponsors and Collaborators

Discovery Laboratories

Investigators

Study Director:

Timothy J Gregory, PhD

Discovery Laboratories

More Information

No publications provided

Responsible Party:	Discovery Laboratories
ClinicalTrials.gov Identifier:	NCT00215553 History of Changes
Other Study ID Numbers:	KL4-ARDS-04
Study First Received:	September 14, 2005
Results First Received:	April 2, 2012
Last Updated:	April 2, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases

Infant, Newborn, Diseases
Lung Injury
Pulmonary Surfactants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013