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

Sponsor
University of Giessen (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02595060
Collaborator
(none)
45
Enrollment
7
Locations
3
Arms
78.9
Anticipated Duration (Months)
6.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: inhaled molgramostim (rhGM-CSF)
  • Drug: inhaled placebo
 Phase 2

Study Design

Study Type:
Interventional
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 :
Jan 1, 2016
Actual Primary Completion Date :
Sep 22, 2021
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. GI-HOPE score representing changes at Day 4/5 with respect to Baseline (Day -1) [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 [baseline to 28 days]

  2. Oxygenation [Baseline to Day 11]

    PaO2/FiO2

  3. Acute Physiology and Chronic Health Evaluation (APACHE) [Baseline to Day 11]

  4. Sequential Organ Failure Assessment (SOFA) [Baseline to Day 11]

  5. Extravascular Lung Water Index [Baseline to Day 11]

  6. C-reactive Protein [Baseline to Day 11]

  7. Days on vasoactive drugs [Baseline to Day 28]

  8. All cause mortality [Baseline to Day 28]

  9. Serum GM-CSF [Baseline, Days 1-4]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie Würzburg Baden-Würtemberg Germany 97080
2 Universitätsklinikum Frankfurt, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie Frankfurt Germany 60590
3 Universities of Marburg and Giessen Lung Center Giessen Germany
4 Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin Hamburg Germany 20246
5 Medizinische Hochschule Hannover, Klinik für Pneumologie Hannover Germany 30625
6 Universitätsklinikum Jena, Klinik für Anästhesiologie und Intensivmedizin Jena Germany 07747
7 University Hospital Marburg, Department of Anaesthesiology and Intensive Care Medicine Marburg Germany

Sponsors and Collaborators

  • University of Giessen

Investigators

  • Principal Investigator: Susanne Herold, Prof.Dr.med.,PhD, Universities of Giessen and Marburg Lung Centers, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Giessen
ClinicalTrials.gov Identifier:
NCT02595060
Other Study ID Numbers:
  • MOL-ARDS-002
First Posted:
Nov 3, 2015
Last Update Posted:
Oct 28, 2021
Last Verified:
May 1, 2021
Keywords provided by University of Giessen
acute lung injury, molgramostim, GM-CSF, pneumonia, barrier restoration
Additional relevant MeSH terms:
Respiratory Aspiration
Molgramostim
Sargramostim

Study Results

No Results Posted as of Oct 28, 2021