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Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) Inhalation to Improve Host Defense and Pulmonary Barrier Restoration (GI-HOPE)

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ClinicalTrials.gov Identifier: NCT02595060
Recruitment Status : Recruiting
First Posted : November 3, 2015
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of Giessen

Brief Summary:
This trial evaluates efficacy and safety of inhaled molgramostim (rhGM-CSF) in 45 patients with pneumonia associated acute respiratory distress syndrome (ARDS). A third of the patients will receive 150 mcg inhaled molgramostim, another third 450 mcg and the remaining third will receive inhaled placebo for 3 days. The patients will be followed for 28 days.

Condition or disease Intervention/treatment Phase
ARDS Drug: inhaled molgramostim (rhGM-CSF) Drug: inhaled placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: GM-CSF Inhalation to Improve Host Defense and Pulmonary Barrier Restoration (GI-HOPE). A Randomized, Double-blind, Parallel Group, Multicenter, Phase II Study
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 150 mcg inhaled molgramostim
once daily inhaled molgramostim (rhGM-CSF) for 3 days
Drug: inhaled molgramostim (rhGM-CSF)
Experimental: 450 mcg inhaled molgramostim
once daily inhaled molgramostim (rhGM-CSF) for 3 days
Drug: inhaled molgramostim (rhGM-CSF)
Placebo Comparator: inhaled placebo
once daily inhaled placebo for 3 days
Drug: inhaled placebo
formulated as the active substance without molgramostim




Primary Outcome Measures :
  1. GI-HOPE score representing changes at Day 4/5 with respect to Baseline (Day -1) [ Time Frame: baseline and Day 4/5 ]
    The GI-HOPE score assesses change in bronchoalveolar lavage fluid (BALF) mononuclear phagocyte activation/polarization by flow cytometry (mean fluorescence intensities of parameters CD80, CD86, CD206, HLA-DR) with respect to baseline.


Secondary Outcome Measures :
  1. Number of patients with Adverse Events (AE), Serious AEs and Adverse Drug Reactions [ Time Frame: baseline to 28 days ]
  2. Oxygenation [ Time Frame: Baseline to Day 11 ]
    PaO2/FiO2

  3. Acute Physiology and Chronic Health Evaluation (APACHE) [ Time Frame: Baseline to Day 11 ]
  4. Sequential Organ Failure Assessment (SOFA) [ Time Frame: Baseline to Day 11 ]
  5. Extravascular Lung Water Index [ Time Frame: Baseline to Day 11 ]
  6. C-reactive Protein [ Time Frame: Baseline to Day 11 ]
  7. Days on vasoactive drugs [ Time Frame: Baseline to Day 28 ]
  8. All cause mortality [ Time Frame: Baseline to Day 28 ]
  9. Serum GM-CSF [ Time Frame: Baseline, Days 1-4 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent form by the patient or a legal representative according to local regulations
  2. Man or woman 18 to 75 years of age, inclusive
  3. Women who have been post-menopausal for more than 1 year or women of childbearing potential period using a highly efficient method of contraception (i.e. a method with less than 1% failure rate such as combined hormonal contraception, progesterone-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tube occlusion, vasectomized partner, sexual abstinence) during dosing and hospitalisation. Women must have a negative serum or urine pregnancy test before the first dose of study medication and must not be lactating.
  4. Diagnosis of pneumonia-associated ARDS, where the underlying condition is Community-Acquired Pneumonia (CAP) or Hospital-Acquired Pneumonia (HAP) in patients not on invasive ventilation upon diagnosis of HAP.
  5. Diagnosis of ARDS according to the Berlin ARDS definition.
  6. Requirement for positive pressure ventilation (non-invasive or via endotracheal tube) for more than 72 hours in total with inspiratory oxygen concentration (FiO2) ≥ 50% (or less when on additional ECMO therapy) not longer than 14 days

Exclusion Criteria:

  1. Receiving vasopressors of >100 µg/min
  2. History of liver cirrhosis Child Pugh C, chronic hemodialysis (before severe pneumonia/ARDS), lung cancer
  3. Malignancy with expected survival time of less than 6 months
  4. History of or listing for lung transplantation
  5. Highly immunosuppressive therapy or anti-malignant combination chemotherapy within 3 weeks prior to first dose of study drug
  6. Any anti-malignant chemotherapy within 24 hours prior to first dose of study drug
  7. AIDS or known history of HIV infection
  8. Pregnancy
  9. Autoimmune thrombocytopenia, myelodysplastic syndromes with > 20% marrow blast cells
  10. History or presence of hypersensitivity or idiosyncratic reaction to molgramostim or to related compounds (i.e., Growgen®, Leucomax®, Leukine™, Topleucon™)
  11. Participation in another clinical trial within 90 days prior to the first dose of study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595060


Contacts
Contact: Susanne Herold, Prof.Dr.med.,PhD susanne.herold@innere.med.uni-giessen.de
Contact: Katarzyna Piskulak, Dr. katarzyna.piskulak@KKS.uni-marburg.de

Locations
Germany
Universitätsklinikum Frankfurt, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie Recruiting
Frankfurt, Germany, 60590
Contact: Kai Zacharowski, Prof. Dr. Dr., MD         
Principal Investigator: Kai Zacharowski, Prof. Dr. Dr., MD         
Universities of Marburg and Giessen Lung Center Recruiting
Giessen, Germany
Contact: Susanne Herold, MD, PhD         
Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin Recruiting
Hamburg, Germany, 20246
Contact: Stefan Kluge, MD, Prof. Dr.         
Principal Investigator: Stefan Kluge, MD, Prof. Dr.         
Medizinische Hochschule Hannover, Klinik für Pneumologie Recruiting
Hannover, Germany, 30625
Contact: Tobias Welte, Prof. Dr., MD         
Principal Investigator: Tobias Welte, Prof. Dr., MD         
Universitätsklinikum Jena, Klinik für Anästhesiologie und Intensivmedizin Recruiting
Jena, Germany, 07747
Contact: Michael Bauer, MD, Prof. Dr         
Principal Investigator: Michael Bauer, MD, Prof. Dr         
University Hospital Marburg, Department of Anaesthesiology and Intensive Care Medicine Recruiting
Marburg, Germany
Contact: Hinnerk Wulf, MD, Prof. Dr         
Principal Investigator: Hinnerk Wulf, MD, Prof. Dr         
Sponsors and Collaborators
University of Giessen
Investigators
Principal Investigator: Susanne Herold, Prof.Dr.med.,PhD Universities of Giessen and Marburg Lung Centers, Germany

Publications:

Responsible Party: University of Giessen
ClinicalTrials.gov Identifier: NCT02595060     History of Changes
Other Study ID Numbers: MOL-ARDS-002
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

Keywords provided by University of Giessen:
acute lung injury, molgramostim, GM-CSF, pneumonia, barrier restoration

Additional relevant MeSH terms:
Molgramostim
Antineoplastic Agents