Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-09 @ 8:17 AM
Study NCT ID:
NCT02595060
Status:
COMPLETED
Last Update Posted:
2023-08-31
First Post:
2015-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) Inhalation to Improve Host Defense and Pulmonary Barrier Restoration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C082856', 'term': 'regramostim'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-30', 'studyFirstSubmitDate': '2015-11-01', 'studyFirstSubmitQcDate': '2015-11-01', 'lastUpdatePostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GI-HOPE score representing changes at Day 4/5 with respect to Baseline (Day -1)', 'timeFrame': 'baseline and Day 4/5', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of patients with Adverse Events (AE), Serious AEs and Adverse Drug Reactions', 'timeFrame': 'baseline to 28 days'}, {'measure': 'Oxygenation', 'timeFrame': 'Baseline to Day 11', 'description': 'PaO2/FiO2'}, {'measure': 'Acute Physiology and Chronic Health Evaluation (APACHE)', 'timeFrame': 'Baseline to Day 11'}, {'measure': 'Sequential Organ Failure Assessment (SOFA)', 'timeFrame': 'Baseline to Day 11'}, {'measure': 'Extravascular Lung Water Index', 'timeFrame': 'Baseline to Day 11'}, {'measure': 'C-reactive Protein', 'timeFrame': 'Baseline to Day 11'}, {'measure': 'Days on vasoactive drugs', 'timeFrame': 'Baseline to Day 28'}, {'measure': 'All cause mortality', 'timeFrame': 'Baseline to Day 28'}, {'measure': 'Serum GM-CSF', 'timeFrame': 'Baseline, Days 1-4'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute lung injury, molgramostim, GM-CSF, pneumonia, barrier restoration'], 'conditions': ['ARDS']}, 'referencesModule': {'references': [{'pmid': '24579839', 'type': 'BACKGROUND', 'citation': 'Herold S, Hoegner K, Vadasz I, Gessler T, Wilhelm J, Mayer K, Morty RE, Walmrath HD, Seeger W, Lohmeyer J. Inhaled granulocyte/macrophage colony-stimulating factor as treatment of pneumonia-associated acute respiratory distress syndrome. Am J Respir Crit Care Med. 2014 Mar 1;189(5):609-11. doi: 10.1164/rccm.201311-2041LE. No abstract available.'}, {'pmid': '19590023', 'type': 'BACKGROUND', 'citation': 'Cakarova L, Marsh LM, Wilhelm J, Mayer K, Grimminger F, Seeger W, Lohmeyer J, Herold S. Macrophage tumor necrosis factor-alpha induces epithelial expression of granulocyte-macrophage colony-stimulating factor: impact on alveolar epithelial repair. Am J Respir Crit Care Med. 2009 Sep 15;180(6):521-32. doi: 10.1164/rccm.200812-1837OC. Epub 2009 Jul 9.'}, {'pmid': '22996662', 'type': 'BACKGROUND', 'citation': 'Unkel B, Hoegner K, Clausen BE, Lewe-Schlosser P, Bodner J, Gattenloehner S, Janssen H, Seeger W, Lohmeyer J, Herold S. Alveolar epithelial cells orchestrate DC function in murine viral pneumonia. J Clin Invest. 2012 Oct;122(10):3652-64. doi: 10.1172/JCI62139. Epub 2012 Sep 10.'}, {'pmid': '16474098', 'type': 'BACKGROUND', 'citation': 'Ballinger MN, Paine R 3rd, Serezani CH, Aronoff DM, Choi ES, Standiford TJ, Toews GB, Moore BB. Role of granulocyte macrophage colony-stimulating factor during gram-negative lung infection with Pseudomonas aeruginosa. Am J Respir Cell Mol Biol. 2006 Jun;34(6):766-74. doi: 10.1165/rcmb.2005-0246OC. Epub 2006 Feb 10.'}, {'pmid': '22160309', 'type': 'BACKGROUND', 'citation': 'Standiford LR, Standiford TJ, Newstead MJ, Zeng X, Ballinger MN, Kovach MA, Reka AK, Bhan U. TLR4-dependent GM-CSF protects against lung injury in Gram-negative bacterial pneumonia. Am J Physiol Lung Cell Mol Physiol. 2012 Mar 1;302(5):L447-54. doi: 10.1152/ajplung.00415.2010. Epub 2011 Dec 9.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent form by the patient or a legal representative according to local regulations\n2. Man or woman 18 to 75 years of age, inclusive\n3. 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.\n4. 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.\n5. Diagnosis of ARDS according to the Berlin ARDS definition.\n6. 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\n\nExclusion Criteria:\n\n1. Receiving vasopressors of \\>100 µg/min\n2. History of liver cirrhosis Child Pugh C, chronic hemodialysis (before severe pneumonia/ARDS), lung cancer\n3. Malignancy with expected survival time of less than 6 months\n4. History of or listing for lung transplantation\n5. Highly immunosuppressive therapy or anti-malignant combination chemotherapy within 3 weeks prior to first dose of study drug\n6. Any anti-malignant chemotherapy within 24 hours prior to first dose of study drug\n7. AIDS or known history of HIV infection\n8. Pregnancy\n9. Autoimmune thrombocytopenia, myelodysplastic syndromes with \\> 20% marrow blast cells\n10. History or presence of hypersensitivity or idiosyncratic reaction to molgramostim or to related compounds (i.e., Growgen®, Leucomax®, Leukine™, Topleucon™)\n11. Participation in another clinical trial within 90 days prior to the first dose of study drug'}, 'identificationModule': {'nctId': 'NCT02595060', 'acronym': 'GI-HOPE', 'briefTitle': 'Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) Inhalation to Improve Host Defense and Pulmonary Barrier Restoration', 'organization': {'class': 'OTHER', 'fullName': 'University of Giessen'}, 'officialTitle': 'GM-CSF Inhalation to Improve Host Defense and Pulmonary Barrier Restoration (GI-HOPE). A Randomized, Double-blind, Parallel Group, Multicenter, Phase II Study', 'orgStudyIdInfo': {'id': 'MOL-ARDS-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '150 mcg inhaled molgramostim', 'description': 'once daily inhaled molgramostim (rhGM-CSF) for 3 days', 'interventionNames': ['Drug: inhaled molgramostim (rhGM-CSF)']}, {'type': 'EXPERIMENTAL', 'label': '450 mcg inhaled molgramostim', 'description': 'once daily inhaled molgramostim (rhGM-CSF) for 3 days', 'interventionNames': ['Drug: inhaled molgramostim (rhGM-CSF)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'inhaled placebo', 'description': 'once daily inhaled placebo for 3 days', 'interventionNames': ['Drug: inhaled placebo']}], 'interventions': [{'name': 'inhaled molgramostim (rhGM-CSF)', 'type': 'DRUG', 'armGroupLabels': ['150 mcg inhaled molgramostim', '450 mcg inhaled molgramostim']}, {'name': 'inhaled placebo', 'type': 'DRUG', 'description': 'formulated as the active substance without molgramostim', 'armGroupLabels': ['inhaled placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97080', 'city': 'Würzburg', 'state': 'Baden-Würtemberg', 'country': 'Germany', 'facility': 'Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Universitätsklinikum Frankfurt, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Giessen', 'country': 'Germany', 'facility': 'Universities of Marburg and Giessen Lung Center', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover, Klinik für Pneumologie', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '07747', 'city': 'Jena', 'country': 'Germany', 'facility': 'Universitätsklinikum Jena, Klinik für Anästhesiologie und Intensivmedizin', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Marburg', 'country': 'Germany', 'facility': 'University Hospital Marburg, Department of Anaesthesiology and Intensive Care Medicine', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}], 'overallOfficials': [{'name': 'Susanne Herold, Prof.Dr.med.,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universities of Giessen and Marburg Lung Centers, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Giessen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}