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 :
Completed
First Posted : November 3, 2015
Last Update Posted : August 31, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
ARDS | Drug: inhaled molgramostim (rhGM-CSF) Drug: inhaled placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual 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 : | June 1, 2016 |
Actual Primary Completion Date : | September 22, 2021 |
Actual Study Completion Date : | July 31, 2022 |
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 |
- 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.
- Number of patients with Adverse Events (AE), Serious AEs and Adverse Drug Reactions [ Time Frame: baseline to 28 days ]
- Oxygenation [ Time Frame: Baseline to Day 11 ]PaO2/FiO2
- Acute Physiology and Chronic Health Evaluation (APACHE) [ Time Frame: Baseline to Day 11 ]
- Sequential Organ Failure Assessment (SOFA) [ Time Frame: Baseline to Day 11 ]
- Extravascular Lung Water Index [ Time Frame: Baseline to Day 11 ]
- C-reactive Protein [ Time Frame: Baseline to Day 11 ]
- Days on vasoactive drugs [ Time Frame: Baseline to Day 28 ]
- All cause mortality [ Time Frame: Baseline to Day 28 ]
- 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 |
Inclusion Criteria:
- Signed informed consent form by the patient or a legal representative according to local regulations
- Man or woman 18 to 75 years of age, inclusive
- 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.
- 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.
- Diagnosis of ARDS according to the Berlin ARDS definition.
- 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:
- Receiving vasopressors of >100 µg/min
- History of liver cirrhosis Child Pugh C, chronic hemodialysis (before severe pneumonia/ARDS), lung cancer
- Malignancy with expected survival time of less than 6 months
- History of or listing for lung transplantation
- Highly immunosuppressive therapy or anti-malignant combination chemotherapy within 3 weeks prior to first dose of study drug
- Any anti-malignant chemotherapy within 24 hours prior to first dose of study drug
- AIDS or known history of HIV infection
- Pregnancy
- Autoimmune thrombocytopenia, myelodysplastic syndromes with > 20% marrow blast cells
- History or presence of hypersensitivity or idiosyncratic reaction to molgramostim or to related compounds (i.e., Growgen®, Leucomax®, Leukine™, Topleucon™)
- Participation in another clinical trial within 90 days prior to the first dose of study drug
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
Germany | |
Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie | |
Würzburg, Baden-Würtemberg, Germany, 97080 | |
Universitätsklinikum Frankfurt, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie | |
Frankfurt, Germany, 60590 | |
Universities of Marburg and Giessen Lung Center | |
Giessen, Germany | |
Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin | |
Hamburg, Germany, 20246 | |
Medizinische Hochschule Hannover, Klinik für Pneumologie | |
Hannover, Germany, 30625 | |
Universitätsklinikum Jena, Klinik für Anästhesiologie und Intensivmedizin | |
Jena, Germany, 07747 | |
University Hospital Marburg, Department of Anaesthesiology and Intensive Care Medicine | |
Marburg, Germany |
Principal Investigator: | Susanne Herold, Prof.Dr.med.,PhD | Universities of Giessen and Marburg Lung Centers, Germany |
Responsible Party: | University of Giessen |
ClinicalTrials.gov Identifier: | NCT02595060 |
Other Study ID Numbers: |
MOL-ARDS-002 |
First Posted: | November 3, 2015 Key Record Dates |
Last Update Posted: | August 31, 2023 |
Last Verified: | August 2023 |
acute lung injury, molgramostim, GM-CSF, pneumonia, barrier restoration |
Respiratory Aspiration Respiration Disorders Respiratory Tract Diseases Pathologic Processes Molgramostim |
Sargramostim Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs |