Clinical trial NCT00215553: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Windtree Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 124
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.
timeFrame: Through 28 days
Secondary outcomes:
measure: Mortality
timeFrame: Through 28 days
measure: Days in ICU
timeFrame: Through 28 days
Other outcomes:
Locations:
city: Warrington
country: United States
facility: Discovery Laboratories, Inc.
state: Pennsylvania
Study officials:
affiliation: Windtree Therapeutics
name: Timothy J Gregory, PhD
role: STUDY_DIRECTOR
References: