Trial · NCT00201409

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

NCT00201409, Phase 2, Completed, University of Michigan; results first posted 2015-04-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Randomized Trial of GM-CSF in Patients With ALI/ARDS. Trials, record NCT00201409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00201409

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Randomized Trial of GM-CSF in Patients With ALI/ARDS
NCT number: NCT00201409
Status: Completed
Phases: Phase 2
Enrollment: 132 participants, actual
Lead sponsor: University of Michigan
Conditions: Respiratory Distress Syndrome, Adult
Interventions: Placebo, GM-CSF
First posted: 2005-09-20
Last updated: 2015-12-29
Results first posted: 2015-04-27

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Ventilator-free Days During Days 1-28	Measured at Day 28
Secondary	Oxygenation Index Change at Day 15 From Day 1	Day 1, Day 15	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).
Secondary	Days Without Organ Failure	Measured at Day 28	Non-respiratory

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Ventilator-free Days During Days 1-28	Measured at Day 28	Days	MEAN
SECONDARY	Oxygenation Index Change at Day 15 From Day 1	Day 1, Day 15	oxygenation index	MEAN
SECONDARY	Days Without Organ Failure	Measured at Day 28	days	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Ventilator-free Days During Days 1-28	GM-CSF Group	10.8	Standard Deviation 10.5	Days
Ventilator-free Days During Days 1-28	Placebo Group	10.7	Standard Deviation 10.3	Days
Oxygenation Index Change at Day 15 From Day 1	GM-CSF Group	-3.5	Standard Deviation 10.4	oxygenation index
Oxygenation Index Change at Day 15 From Day 1	Placebo Group	-4.6	Standard Deviation 4.5	oxygenation index
Days Without Organ Failure	GM-CSF Group	15.7	Standard Deviation 11.9	days
Days Without Organ Failure	Placebo Group	12.8	Standard Deviation 11.3	days

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	GM-CSF Group	65
Overall Study	STARTED	Placebo Group	67
Overall Study	COMPLETED	GM-CSF Group	64
Overall Study	COMPLETED	Placebo Group	66
Overall Study	NOT COMPLETED	GM-CSF Group	1
Overall Study	NOT COMPLETED	Placebo Group	1

Source ClinicalTrials.gov

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Cardiovascular	Cardiac disorders	GM-CSF Group	25	64	25
other	Cardiovascular	Cardiac disorders	Placebo Group	25	66	25
other	Fever	Immune system disorders	GM-CSF Group	15	64	15
other	Fever	Immune system disorders	Placebo Group	11	66	11
other	GI	Gastrointestinal disorders	GM-CSF Group	3	64	3
other	GI	Gastrointestinal disorders	Placebo Group	5	66	5
other	Hematologic	Blood and lymphatic system disorders	GM-CSF Group	26	64	26
other	Hematologic	Blood and lymphatic system disorders	Placebo Group	17	66	17
other	Infection	Infections and infestations	GM-CSF Group	13	64	13
other	Infection	Infections and infestations	Placebo Group	7	66	7

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GM-CSF Group
Total, all-cause mortality	Placebo Group
Total, other adverse events	GM-CSF Group	39	64
Total, other adverse events	Placebo Group	39	66
Total, serious adverse events	GM-CSF Group	31	64
Total, serious adverse events	Placebo Group	34	66

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
10667491	BACKGROUND	PubMed
11597913	BACKGROUND	PubMed
12119223	BACKGROUND	PubMed
12847267	BACKGROUND	PubMed
14633611	BACKGROUND	PubMed
21926600	DERIVED	PubMed
28358594	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P50HL074024	SCCOR in Translational Research in Acute Lung Injury	STANDIFORD, THEODORE J.	UNIVERSITY OF MICHIGAN AT ANN ARBOR	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2003 to 2007

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
GM-CSF Group vs Placebo Group: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00201409

GET https://conductscience.org/api/trials/v1/NCT00201409/events?page=2

API reference For AI assistants