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A Randomized Trial of GM-CSF in Patients With ALI/ARDS

NCT00201409 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2015-12-29

Study results available
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Summary

This study will test the hypothesis that administration of granulocyte-macrophage colony stimulating factor (GM-CSF) to patients with acute lung injury/acute respiratory distress syndrome (ALI/ARDS) will improve the clinical course and outcome by shortening the duration of mechanical ventilation for these patients.

Conditions

  • Respiratory Distress Syndrome, Adult

Interventions

DRUG

Placebo

Placebo will be administered by slow intravenous infusion once daily for 14 days.

DRUG

GM-CSF

Recombinant human GM-CSF (250 mcg/M2) will be administered by slow intravenous infusion once daily for 14 days.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Emory University

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • University of Michigan

    lead OTHER

Principal Investigators

  • Robert Paine, MD · University of Utah and University of Michigan

  • Robert C. Hyzy, M.D. · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2009-05-31
Completion
2009-06-30

Countries

  • United States

Study Locations

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Drugs
Companies

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 NCT00201409 on ClinicalTrials.gov