Trial Outcomes & Findings for A Randomized Trial of GM-CSF in Patients With ALI/ARDS (NCT NCT00201409)
NCT ID: NCT00201409
Last Updated: 2015-12-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
132 participants
Primary outcome timeframe
Measured at Day 28
Results posted on
2015-12-29
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
67
|
|
Overall Study
COMPLETED
|
64
|
66
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Trial of GM-CSF in Patients With ALI/ARDS
Baseline characteristics by cohort
| Measure |
GM-CSF Group
n=65 Participants
Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
|
Placebo Group
n=67 Participants
Participants will be randomized to receive placebo.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Age, Continuous
|
48.5 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Day 28Outcome measures
| Measure |
GM-CSF Group
n=64 Participants
Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
|
Placebo Group
n=66 Participants
Participants will be randomized to receive placebo.
|
|---|---|---|
|
Ventilator-free Days During Days 1-28
|
10.8 Days
Standard Deviation 10.5
|
10.7 Days
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Day 1, Day 15The 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).
Outcome measures
| Measure |
GM-CSF Group
n=64 Participants
Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
|
Placebo Group
n=66 Participants
Participants will be randomized to receive placebo.
|
|---|---|---|
|
Oxygenation Index Change at Day 15 From Day 1
|
-3.5 oxygenation index
Standard Deviation 10.4
|
-4.6 oxygenation index
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Measured at Day 28Non-respiratory
Outcome measures
| Measure |
GM-CSF Group
n=64 Participants
Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
|
Placebo Group
n=66 Participants
Participants will be randomized to receive placebo.
|
|---|---|---|
|
Days Without Organ Failure
|
15.7 days
Standard Deviation 11.9
|
12.8 days
Standard Deviation 11.3
|
Adverse Events
GM-CSF Group
Serious events: 31 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo Group
Serious events: 34 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GM-CSF Group
n=64 participants at risk
Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
|
Placebo Group
n=66 participants at risk
Participants will be randomized to receive placebo.
|
|---|---|---|
|
Immune system disorders
Sepsis or Multi-organ failure
|
17.2%
11/64 • Number of events 11
|
19.7%
13/66 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary SAE
|
17.2%
11/64 • Number of events 11
|
24.2%
16/66 • Number of events 16
|
|
Infections and infestations
Infection SAE
|
10.9%
7/64 • Number of events 7
|
13.6%
9/66 • Number of events 9
|
|
General disorders
Miscellaneous
|
3.1%
2/64 • Number of events 2
|
0.00%
0/66
|
Other adverse events
| Measure |
GM-CSF Group
n=64 participants at risk
Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
|
Placebo Group
n=66 participants at risk
Participants will be randomized to receive placebo.
|
|---|---|---|
|
Cardiac disorders
Cardiovascular
|
39.1%
25/64 • Number of events 25
|
37.9%
25/66 • Number of events 25
|
|
Immune system disorders
Fever
|
23.4%
15/64 • Number of events 15
|
16.7%
11/66 • Number of events 11
|
|
Gastrointestinal disorders
GI
|
4.7%
3/64 • Number of events 3
|
7.6%
5/66 • Number of events 5
|
|
Blood and lymphatic system disorders
Hematologic
|
40.6%
26/64 • Number of events 26
|
25.8%
17/66 • Number of events 17
|
|
Infections and infestations
Infection
|
20.3%
13/64 • Number of events 13
|
10.6%
7/66 • Number of events 7
|
|
Nervous system disorders
Neurologic
|
6.2%
4/64 • Number of events 4
|
1.5%
1/66 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
18.8%
12/64 • Number of events 12
|
27.3%
18/66 • Number of events 18
|
|
Hepatobiliary disorders
Renal/Hepatic
|
7.8%
5/64 • Number of events 5
|
12.1%
8/66 • Number of events 8
|
|
Metabolism and nutrition disorders
Metabolic
|
10.9%
7/64 • Number of events 7
|
10.6%
7/66 • Number of events 7
|
|
General disorders
Miscellaneous
|
10.9%
7/64 • Number of events 7
|
6.1%
4/66 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place