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

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Emory University
University of Colorado, Denver
Information provided by (Responsible Party):
Robert C. Hyzy, MD, University of Michigan
ClinicalTrials.gov Identifier:
NCT00201409
First received: September 12, 2005
Last updated: November 30, 2015
Last verified: November 2015
Results First Received: June 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Respiratory Distress Syndrome, Adult
Interventions: Drug: Placebo
Drug: GM-CSF

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
GM-CSF Group Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
Placebo Group Participants will be randomized to receive placebo.

Participant Flow:   Overall Study
    GM-CSF Group     Placebo Group  
STARTED     65     67  
COMPLETED     64     66  
NOT COMPLETED     1     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
GM-CSF Group Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
Placebo Group Participants will be randomized to receive placebo.
Total Total of all reporting groups

Baseline Measures
    GM-CSF Group     Placebo Group     Total  
Number of Participants  
[units: participants]
  65     67     132  
Age  
[units: years]
Mean (Standard Deviation)
  48.5  (15.6)     48.3  (13.8)     48.4  (14.6)  
Gender  
[units: participants]
     
Female     30     28     58  
Male     35     39     74  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Ventilator-free Days During Days 1-28   [ Time Frame: Measured at Day 28 ]

2.  Secondary:   Oxygenation Index Change at Day 15 From Day 1   [ Time Frame: Day 1, Day 15 ]

3.  Secondary:   Days Without Organ Failure   [ Time Frame: Measured at Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Robert Hyzy
Organization: University of Michigan
phone: 7349365201
e-mail: rhyzy@umich.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Robert C. Hyzy, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT00201409     History of Changes
Other Study ID Numbers: 258
P50HL074024 ( US NIH Grant/Contract Award Number )
Study First Received: September 12, 2005
Results First Received: June 25, 2012
Last Updated: November 30, 2015
Health Authority: United States: Food and Drug Administration