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Completed

NCT Number: NCT02595060

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

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.

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Key information

Conditions

ARDS Acute Lung Injury Infections Lung Diseases Lung Injury Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie, Würzburg, Baden-Würtemberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inhaled molgramostim (rhGM-CSF)

Drug

Inhaled placebo

Drug

formulated as the active substance without molgramostim

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study title

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

Acronym: GI-HOPE

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Nov 3, 2015
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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