Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 50 for:    GI HOPE
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02595060
Recruitment Status : Recruiting
First Posted : November 3, 2015
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
University of Giessen

Tracking Information
First Submitted Date  ICMJE November 1, 2015
First Posted Date  ICMJE November 3, 2015
Last Update Posted Date May 21, 2021
Actual Study Start Date  ICMJE January 2016
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2015)
Change from Baseline (Day -1) to Day 4/5 in GI-HOPE score [ 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) Inhalation to Improve Host Defense and Pulmonary Barrier Restoration
Official Title  ICMJE GM-CSF Inhalation to Improve Host Defense and Pulmonary Barrier Restoration (GI-HOPE). A Randomized, Double-blind, Parallel Group, Multicenter, Phase II Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE ARDS
Intervention  ICMJE
  • Drug: inhaled molgramostim (rhGM-CSF)
  • Drug: inhaled placebo
    formulated as the active substance without molgramostim
Study Arms  ICMJE
  • Experimental: 150 mcg inhaled molgramostim
    once daily inhaled molgramostim (rhGM-CSF) for 3 days
    Intervention: Drug: inhaled molgramostim (rhGM-CSF)
  • Experimental: 450 mcg inhaled molgramostim
    once daily inhaled molgramostim (rhGM-CSF) for 3 days
    Intervention: Drug: inhaled molgramostim (rhGM-CSF)
  • Placebo Comparator: inhaled placebo
    once daily inhaled placebo for 3 days
    Intervention: Drug: inhaled placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2015)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Susanne Herold, Prof.Dr.med.,PhD susanne.herold@innere.med.uni-giessen.de
Contact: Nelli Ens-Jaeger nelli.ens@KKS.uni-marburg.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02595060
Other Study ID Numbers  ICMJE MOL-ARDS-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Giessen
Study Sponsor  ICMJE University of Giessen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Susanne Herold, Prof.Dr.med.,PhD Universities of Giessen and Marburg Lung Centers, Germany
PRS Account University of Giessen
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP