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KL₄Surfactant Treatment in Patients With ARDS

NCT00215553 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2018-08-09

Study results available
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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

Interventions

DRUG

A.1 Lucinactant

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

OTHER

B.3 SoC

Standard ARDS management and ICU care

DRUG

A.2 Lucinactant

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

DRUG

A.3 Lucinactant

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

DRUG

A.4 Lucinactant

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

DRUG

B.1 Lucinactant

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

DRUG

B.2 Lucinactant

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

Sponsors & Collaborators

  • Windtree Therapeutics

    lead INDUSTRY

Principal Investigators

  • Timothy J Gregory, PhD · Windtree Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-31
Primary Completion
2006-02-28
Completion
2006-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00215553 on ClinicalTrials.gov