Respiratory Distress Syndrome, AdultPhase 2NCT00201409
A Randomized Trial of GM-CSF in Patients With ALI/ARDS
A Phase 2 study testing GM-CSF in people with Respiratory Distress Syndrome, Adult, run by University of Michigan at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- GM-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2004to Jun 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute onset of illness with:
- PaO2/FiO2 ratio of less than 300 (ALI) or PaO2/FiO2 ratio of less than 200 (ARDS)
- Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph (infiltrates may be patchy, diffuse, homogeneous, or asymmetric)
- Requirement for positive pressure ventilation via an endotracheal tube
- No clinical evidence of left atrial hypertension (pulmonary arterial wedge pressure measure up to 18 mm Hg)
- First three criteria must occur together within a 24-hour interval
Who cannot join
- Greater than 7 days elapsed following institution of mechanical ventilation
- Pregnancy
- Chronic respiratory failure as defined by any of the following: 1) FEV1 less than 20 ml/kg of PBW; or 2) FEV1/FVC less than 50%
- Chronic hypercapnia or hypoxemia
- Hospitalization within the past 6 months for acute respiratory failure
- Chronic home use of oxygen or mechanical ventilation
Show all 19Show fewer
- Left ventricular failure as defined by New York Heart Association (NYHA) class IV status
- Neutropenia (absolute neutrophil count less than 1000 cells/mm3)
- History of hematological malignancy or bone marrow transplant
- Entry into other intervention clinical trials
- Decision of the patient or attending physician to forego aggressive care
- Expected survival rate of less than 6 months (based solely on pre-existing medical problems [i.e., poorly controlled neoplasm or other end-stage disease])
- AIDS or known history of HIV infection
- Prednisone (or equivalent) therapy greater than or equal to 20 mg/day for a period of not less than 2 months with treatment continuing within 3 weeks prior to screening
- Cytotoxic therapy within 3 weeks of screening
- Morbid obesity defined as greater than 1 kg/c, body weight
- At risk for increased intracranial pressure that may result from permissive hypercapnia or in whom permissive hypercapnia may be otherwise contraindicated
- Neuromuscular disease that would potentially impact ability to wean from mechanical ventilation
- Receiving extracorporeal membrane oxygenation when meeting screening criteria
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30303
University of Colorado Health Sciences Center
Denver, Colorado, 80045
About this study
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.
Read the detailed description
BACKGROUND:
Respiratory failure due to ALI/ARDS remains a major health problem, despite significant progress in intensive care unit care and ventilator management. ALI/ARDS is characterized by unacceptably high mortality despite enormous expenditure of health care resources. Survivors face long-term consequences that may affect their quality of life. New therapies are needed to improve early survival and to decrease long-term sequelae of this syndrome. GM-CSF is a naturally occurring cytokine that is present in the normal lung, with important roles in pulmonary homeostasis. GM-CSF is essential for normal maturation and function of alveolar macrophages (resident inflammatory cells that are responsible for initial defense against pneumonia). Alveolar epithelial cells line the gas exchange surface of the lung. Acute lung injury and subsequent abnormal healing is linked to delayed repair of damage to the epithelium following initial injury. This can then lead to pulmonary fibrosis. GM-CSF has potent effects on alveolar epithelial cells, promoting proliferation and limiting epithelial cell death. Thus, GM-CSF has a distinctive combination of activities that make it an excellent candidate for a therapeutic intervention in ALI/ARDS. Preliminary studies for this project demonstrate that GM-CSF can protect experimental animals against acute lung injury, can decrease susceptibility to pneumonia, and is protective against pulmonary fibrosis following acute lung injury. There is extensive experience with the administration of recombinant human GM-CSF to human patients (this biological is approved by the FDA and has been well-tolerated in trials involving critically ill patients). This project is based on the hypothesis that administration of GM-CSF will improve clinical outcomes for patients with ALI/ARDS.
DESIGN NARRATIVE:
With the assent of the attending physician, informed consent will be obtained from the patient or next of kin as soon as possible after case identification. Physiologic measurements and specimen collection will begin at the time of entry into the study. Three days after the patient has met criteria for ALI/ARDS or at entry into the study (whichever is later), he/she will be randomized to receive recombinant human GM-CSF (250 mcg/M2) or placebo, administered by slow intravenous infusion once daily for 14 days.
This study will allow entry of patients who have fulfilled criteria for ALI/ARDS for up to 7 days. Treatment will be initiated after patients have met criteria for at least 3 days. Treatment with GM-CSF may prove both safe and effective within the first 1-2 days of lung injury. However, the present study will not address that question. It is unlikely that the opportunity for improved outcome will be lost by delaying therapy for up to 3 days (based on the proposed mechanisms by which GM-CSF might benefit this patient population). Similarly, the decision to treat for 14 days will allow for improved outcome in patients with non-resolving ARDS by reducing the incidence of ventilator-associated pneumonia and by decreasing pathologic fibroproliferation.
The primary endpoint for this study will be the duration of mechanical ventilation. Additional important endpoints will include changes in the severity of physiologic derangements of respiratory gas exchange, non-respiratory organ failure, and incidence of ventilator-associated pneumonia. Additional assessments designed to determine the mechanism of benefit of GM-CSF treatment will include measures of lung epithelial cell integrity and measures of alveolar macrophage (lung inflammatory cell) function.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- Placebo, GM-CSF
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo will be administered by slow intravenous infusion once daily for 14 days.
GM-CSFDrug
Recombinant human GM-CSF (250 mcg/M2) will be administered by slow intravenous infusion once daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2). Receives: Drug: GM-CSF |
| 2 | Placebo comparator | Participants will be randomized to receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free Days During Days 1-28
Measured: Measured at Day 28
Secondary outcomes (2)
Oxygenation Index Change at Day 15 From Day 1
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).
Measured: Day 1, Day 15
Days Without Organ Failure
Non-respiratory
Measured: Measured at Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Emory University, University of Colorado, Denver
- Responsible party
- Principal investigator, Robert C. Hyzy, MD, University of Michigan
- Investigators
- Robert Paine, MD, Study director, University of Utah and University of MichiganRobert C. Hyzy, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201409
- Sponsor's protocol ID
- 258
- Other IDs
- P50HL074024
- Status last verified
- Nov 2015
- First submitted
- 12 Sep 2005
- Last updated
- 29 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Paine R 3rd, Wilcoxen SE, Morris SB, Sartori C, Baleeiro CE, Matthay MA, Christensen PJ. Transgenic overexpression of granulocyte macrophage-colony stimulating factor in the lung prevents hyperoxic lung injury. Am J Pathol. 2003 Dec;163(6):2397-406. doi: 10.1016/S0002-9440(10)63594-8.
PubMed 14633611Paine R 3rd, Morris SB, Jin H, Wilcoxen SE, Phare SM, Moore BB, Coffey MJ, Toews GB. Impaired functional activity of alveolar macrophages from GM-CSF-deficient mice. Am J Physiol Lung Cell Mol Physiol. 2001 Nov;281(5):L1210-8. doi: 10.1152/ajplung.2001.281.5.L1210.
PubMed 11597913Baleeiro CE, Wilcoxen SE, Morris SB, Standiford TJ, Paine R 3rd. Sublethal hyperoxia impairs pulmonary innate immunity. J Immunol. 2003 Jul 15;171(2):955-63. doi: 10.4049/jimmunol.171.2.955.
PubMed 12847267Presneill JJ, Harris T, Stewart AG, Cade JF, Wilson JW. A randomized phase II trial of granulocyte-macrophage colony-stimulating factor therapy in severe sepsis with respiratory dysfunction. Am J Respir Crit Care Med. 2002 Jul 15;166(2):138-43. doi: 10.1164/rccm.2009005.
PubMed 12119223Matute-Bello G, Liles WC, Radella F 2nd, Steinberg KP, Ruzinski JT, Hudson LD, Martin TR. Modulation of neutrophil apoptosis by granulocyte colony-stimulating factor and granulocyte/macrophage colony-stimulating factor during the course of acute respiratory distress syndrome. Crit Care Med. 2000 Jan;28(1):1-7. doi: 10.1097/00003246-200001000-00001.
PubMed 10667491Spencer-Segal JL, Hyzy RC, Iwashyna TJ, Standiford TJ. Psychiatric Symptoms in Survivors of Acute Respiratory Distress Syndrome. Effects of Age, Sex, and Immune Modulation. Ann Am Thorac Soc. 2017 Jun;14(6):960-967. doi: 10.1513/AnnalsATS.201606-468OC.
PubMed 28358594Paine R 3rd, Standiford TJ, Dechert RE, Moss M, Martin GS, Rosenberg AL, Thannickal VJ, Burnham EL, Brown MB, Hyzy RC. A randomized trial of recombinant human granulocyte-macrophage colony stimulating factor for patients with acute lung injury. Crit Care Med. 2012 Jan;40(1):90-7. doi: 10.1097/CCM.0b013e31822d7bf0.
PubMed 21926600
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of GM-CSF in Patients With ALI/ARDS
- ClinicalTrials.gov ID
- NCT00201409
- Acronym / sponsor ID
- 258
- Conditions
- Respiratory Distress Syndrome, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Emory University, University of Colorado, Denver
- Study start
- Jul 2004
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 27 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND:
Respiratory failure due to ALI/ARDS remains a major health problem, despite significant progress in intensive care unit care and ventilator management. ALI/ARDS is characterized by unacceptably high mortality despite enormous expenditure of health care resources. Survivors face long-term consequences that may affect their quality of life. New therapies are needed to improve early survival and to decrease long-term sequelae of this syndrome. GM-CSF is a naturally occurring cytokine that is present in the normal lung, with important roles in pulmonary homeostasis. GM-CSF is essential for normal maturation and function of alveolar macrophages (resident inflammatory cells that are responsible for initial defense against pneumonia). Alveolar epithelial cells line the gas exchange surface of the lung. Acute lung injury and subsequent abnormal healing is linked to delayed repair of damage to the epithelium following initial injury. This can then lead to pulmonary fibrosis. GM-CSF has potent effects on alveolar epithelial cells, promoting proliferation and limiting epithelial cell death. Thus, GM-CSF has a distinctive combination of activities that make it an excellent candidate for a therapeutic intervention in ALI/ARDS. Preliminary studies for this project demonstrate that GM-CSF can protect experimental animals against acute lung injury, can decrease susceptibility to pneumonia, and is protective against pulmonary fibrosis following acute lung injury. There is extensive experience with the administration of recombinant human GM-CSF to human patients (this biological is approved by the FDA and has been well-tolerated in trials involving critically ill patients). This project is based on the hypothesis that administration of GM-CSF will improve clinical outcomes for patients with ALI/ARDS.
DESIGN NARRATIVE:
With the assent of the attending physician, informed consent will be obtained from the patient or next of kin as soon as possible after case identification. Physiologic measurements and specimen collection will begin at the time of entry into the study. Three days after the patient has met criteria for ALI/ARDS or at entry into the study (whichever is later), he/she will be randomized to receive recombinant human GM-CSF (250 mcg/M2) or placebo, administered by slow intravenous infusion once daily for 14 days.
This study will allow entry of patients who have fulfilled criteria for ALI/ARDS for up to 7 days. Treatment will be initiated after patients have met criteria for at least 3 days. Treatment with GM-CSF may prove both safe and effective within the first 1-2 days of lung injury. However, the present study will not address that question. It is unlikely that the opportunity for improved outcome will be lost by delaying therapy for up to 3 days (based on the proposed mechanisms by which GM-CSF might benefit this patient population). Similarly, the decision to treat for 14 days will allow for improved outcome in patients with non-resolving ARDS by reducing the incidence of ventilator-associated pneumonia and by decreasing pathologic fibroproliferation.
The primary endpoint for this study will be the duration of mechanical ventilation. Additional important endpoints will include changes in the severity of physiologic derangements of respiratory gas exchange, non-respiratory organ failure, and incidence of ventilator-associated pneumonia. Additional assessments designed to determine the mechanism of benefit of GM-CSF treatment will include measures of lung epithelial cell integrity and measures of alveolar macrophage (lung inflammatory cell) function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GM-CSFParticipants will be randomized to receive recombinant human GM-CSF (250 mcg/M2). |
| 2 | Placebo comparator | Drug: PlaceboParticipants will be randomized to receive placebo. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- PaO2/FiO2 ratio of less than 300 (ALI) or PaO2/FiO2 ratio of less than 200 (ARDS)
- Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph (infiltrates may be patchy, diffuse, homogeneous, or asymmetric)
- Requirement for positive pressure ventilation via an endotracheal tube
- No clinical evidence of left atrial hypertension (pulmonary arterial wedge pressure measure up to 18 mm Hg)
- First three criteria must occur together within a 24-hour interval
Key exclusion criteria (19 listed)
- Greater than 7 days elapsed following institution of mechanical ventilation
- Pregnancy
- Chronic respiratory failure as defined by any of the following: 1) FEV1 less than 20 ml/kg of PBW; or 2) FEV1/FVC less than 50%
- Chronic hypercapnia or hypoxemia
- Hospitalization within the past 6 months for acute respiratory failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo will be administered by slow intravenous infusion once daily for 14 days. | Drug | 2 |
| GM-CSFRecombinant human GM-CSF (250 mcg/M2) will be administered by slow intravenous infusion once daily for 14 days. | Drug | 1 |
Primary outcome
Ventilator-free Days During Days 1-28
Time frame: Measured at Day 28
2 secondary outcomes
Oxygenation Index Change at Day 15 From Day 1
Time frame: Day 1, Day 15
Days Without Organ Failure
Time frame: Measured at Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14633611Paine R 3rd, Wilcoxen SE, Morris SB, Sartori C, Baleeiro CE, Matthay MA, Christensen PJ. Transgenic overexpression of granulocyte macrophage-colony stimulating factor in the lung prevents hyperoxic lung injury. Am J Pathol. 2003 Dec;163(6):2397-406. doi: 10.1016/S0002-9440(10)63594-8.
- Background: PubMed 11597913Paine R 3rd, Morris SB, Jin H, Wilcoxen SE, Phare SM, Moore BB, Coffey MJ, Toews GB. Impaired functional activity of alveolar macrophages from GM-CSF-deficient mice. Am J Physiol Lung Cell Mol Physiol. 2001 Nov;281(5):L1210-8. doi: 10.1152/ajplung.2001.281.5.L1210.
- Background: PubMed 12847267Baleeiro CE, Wilcoxen SE, Morris SB, Standiford TJ, Paine R 3rd. Sublethal hyperoxia impairs pulmonary innate immunity. J Immunol. 2003 Jul 15;171(2):955-63. doi: 10.4049/jimmunol.171.2.955.
- Background: PubMed 12119223Presneill JJ, Harris T, Stewart AG, Cade JF, Wilson JW. A randomized phase II trial of granulocyte-macrophage colony-stimulating factor therapy in severe sepsis with respiratory dysfunction. Am J Respir Crit Care Med. 2002 Jul 15;166(2):138-43. doi: 10.1164/rccm.2009005.
- Background: PubMed 10667491Matute-Bello G, Liles WC, Radella F 2nd, Steinberg KP, Ruzinski JT, Hudson LD, Martin TR. Modulation of neutrophil apoptosis by granulocyte colony-stimulating factor and granulocyte/macrophage colony-stimulating factor during the course of acute respiratory distress syndrome. Crit Care Med. 2000 Jan;28(1):1-7. doi: 10.1097/00003246-200001000-00001.
- Derived from this study: PubMed 28358594Spencer-Segal JL, Hyzy RC, Iwashyna TJ, Standiford TJ. Psychiatric Symptoms in Survivors of Acute Respiratory Distress Syndrome. Effects of Age, Sex, and Immune Modulation. Ann Am Thorac Soc. 2017 Jun;14(6):960-967. doi: 10.1513/AnnalsATS.201606-468OC.
- Derived from this study: PubMed 21926600Paine R 3rd, Standiford TJ, Dechert RE, Moss M, Martin GS, Rosenberg AL, Thannickal VJ, Burnham EL, Brown MB, Hyzy RC. A randomized trial of recombinant human granulocyte-macrophage colony stimulating factor for patients with acute lung injury. Crit Care Med. 2012 Jan;40(1):90-7. doi: 10.1097/CCM.0b013e31822d7bf0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Paine, MD study director
University of Utah and University of Michigan
Robert C. Hyzy, M.D. principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GM-CSF in people with Respiratory Distress Syndrome, Adult, run by University of Michigan at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free Days During Days 1-28 (time frame: Measured at Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00201409, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2015; AzTrials last refreshed its copy on 6 Nov 2026.