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

August 30, 2023 updated by: University of Giessen

GM-CSF Inhalation to Improve Host Defense and Pulmonary Barrier Restoration (GI-HOPE). A Randomized, Double-blind, Parallel Group, Multicenter, Phase II Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60590
        • Universitätsklinikum Frankfurt, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
      • Giessen, Germany
        • Universities of Marburg and Giessen Lung Center
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover, Klinik für Pneumologie
      • Jena, Germany, 07747
        • Universitätsklinikum Jena, Klinik für Anästhesiologie und Intensivmedizin
      • Marburg, Germany
        • University Hospital Marburg, Department of Anaesthesiology and Intensive Care Medicine
    • Baden-Würtemberg
      • Würzburg, Baden-Würtemberg, Germany, 97080
        • Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and Day 4/5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with Adverse Events (AE), Serious AEs and Adverse Drug Reactions
Time Frame: baseline to 28 days
baseline to 28 days
Oxygenation
Time Frame: Baseline to Day 11
PaO2/FiO2
Baseline to Day 11
Acute Physiology and Chronic Health Evaluation (APACHE)
Time Frame: Baseline to Day 11
Baseline to Day 11
Sequential Organ Failure Assessment (SOFA)
Time Frame: Baseline to Day 11
Baseline to Day 11
Extravascular Lung Water Index
Time Frame: Baseline to Day 11
Baseline to Day 11
C-reactive Protein
Time Frame: Baseline to Day 11
Baseline to Day 11
Days on vasoactive drugs
Time Frame: Baseline to Day 28
Baseline to Day 28
All cause mortality
Time Frame: Baseline to Day 28
Baseline to Day 28
Serum GM-CSF
Time Frame: Baseline, Days 1-4
Baseline, Days 1-4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Giessen

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

September 22, 2021

Study Completion (Actual)

July 31, 2022

Study Registration Dates

First Submitted

November 1, 2015

First Submitted That Met QC Criteria

November 1, 2015

First Posted (Estimated)

November 3, 2015

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOL-ARDS-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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