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

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ClinicalTrials.gov Identifier: NCT00201409
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : April 27, 2015
Last Update Posted : December 29, 2015
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Respiratory Distress Syndrome, Adult
Interventions Drug: Placebo
Drug: GM-CSF
Enrollment 132
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GM-CSF Group Placebo Group
Hide Arm/Group Description Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2). Participants will be randomized to receive placebo.
Period Title: Overall Study
Started 65 67
Completed 64 66
Not Completed 1 1
Arm/Group Title GM-CSF Group Placebo Group Total
Hide Arm/Group Description Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2). Participants will be randomized to receive placebo. Total of all reporting groups
Overall Number of Baseline Participants 65 67 132
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 67 participants 132 participants
48.5  (15.6) 48.3  (13.8) 48.4  (14.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 67 participants 132 participants
Female
30
  46.2%
28
  41.8%
58
  43.9%
Male
35
  53.8%
39
  58.2%
74
  56.1%
1.Primary Outcome
Title Ventilator-free Days During Days 1-28
Hide Description [Not Specified]
Time Frame Measured at Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GM-CSF Group Placebo Group
Hide Arm/Group Description:
Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
Participants will be randomized to receive placebo.
Overall Number of Participants Analyzed 64 66
Mean (Standard Deviation)
Unit of Measure: Days
10.8  (10.5) 10.7  (10.3)
2.Secondary Outcome
Title Oxygenation Index Change at Day 15 From Day 1
Hide Description The oxygenation index is a calculation used in intensive care medicine to measure the fraction of inspired oxygen (FiO2) and its usage within the body. It is calculated as the fraction of inspired oxygen times Mean airway pressure)/Partial pressure of oxygen in arterial blood Day 15 minus first day drug or placebo administered (Day 1).
Time Frame Day 1, Day 15
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GM-CSF Group Placebo Group
Hide Arm/Group Description:
Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
Participants will be randomized to receive placebo.
Overall Number of Participants Analyzed 64 66
Mean (Standard Deviation)
Unit of Measure: oxygenation index
-3.5  (10.4) -4.6  (4.5)
3.Secondary Outcome
Title Days Without Organ Failure
Hide Description Non-respiratory
Time Frame Measured at Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GM-CSF Group Placebo Group
Hide Arm/Group Description:
Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
Participants will be randomized to receive placebo.
Overall Number of Participants Analyzed 64 66
Mean (Standard Deviation)
Unit of Measure: days
15.7  (11.9) 12.8  (11.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GM-CSF Group Placebo Group
Hide Arm/Group Description Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2). Participants will be randomized to receive placebo.
All-Cause Mortality
GM-CSF Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
GM-CSF Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/64 (48.44%)      34/66 (51.52%)    
General disorders     
Miscellaneous  [1]  2/64 (3.13%)  2 0/66 (0.00%) 
Immune system disorders     
Sepsis or Multi-organ failure   11/64 (17.19%)  11 13/66 (19.70%)  13
Infections and infestations     
Infection SAE   7/64 (10.94%)  7 9/66 (13.64%)  9
Respiratory, thoracic and mediastinal disorders     
Pulmonary SAE   11/64 (17.19%)  11 16/66 (24.24%)  16
Indicates events were collected by systematic assessment
[1]
These events were not documented specifically in the records available
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GM-CSF Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/64 (60.94%)      39/66 (59.09%)    
Blood and lymphatic system disorders     
Hematologic  26/64 (40.63%)  26 17/66 (25.76%)  17
Cardiac disorders     
Cardiovascular  25/64 (39.06%)  25 25/66 (37.88%)  25
Gastrointestinal disorders     
GI  3/64 (4.69%)  3 5/66 (7.58%)  5
General disorders     
Miscellaneous   7/64 (10.94%)  7 4/66 (6.06%)  4
Hepatobiliary disorders     
Renal/Hepatic   5/64 (7.81%)  5 8/66 (12.12%)  8
Immune system disorders     
Fever  15/64 (23.44%)  15 11/66 (16.67%)  11
Infections and infestations     
Infection  13/64 (20.31%)  13 7/66 (10.61%)  7
Metabolism and nutrition disorders     
Metabolic   7/64 (10.94%)  7 7/66 (10.61%)  7
Nervous system disorders     
Neurologic  4/64 (6.25%)  4 1/66 (1.52%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary   12/64 (18.75%)  12 18/66 (27.27%)  18
Indicates events were collected by systematic assessment
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
Responsible Party: Robert C. Hyzy, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT00201409     History of Changes
Other Study ID Numbers: 258
P50HL074024 ( U.S. NIH Grant/Contract )
First Submitted: September 12, 2005
First Posted: September 20, 2005
Results First Submitted: June 25, 2012
Results First Posted: April 27, 2015
Last Update Posted: December 29, 2015