NCT02595060已完成2 期
GM-CSF Inhalation to Improve Host Defense and Pulmonary Barrier Restoration (GI-HOPE). A Randomized, Double-blind, Parallel Group, Multicenter, Phase II Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 7
- 主要终点
- GI-HOPE score representing changes at Day 4/5 with respect to Baseline (Day -1)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
150 mcg inhaled molgramostim
Experimental
once daily inhaled molgramostim (rhGM-CSF) for 3 days
干预措施: inhaled molgramostim (rhGM-CSF) (Drug)
450 mcg inhaled molgramostim
Experimental
once daily inhaled molgramostim (rhGM-CSF) for 3 days
干预措施: inhaled molgramostim (rhGM-CSF) (Drug)
inhaled placebo
Placebo Comparator
once daily inhaled placebo for 3 days
干预措施: inhaled placebo (Drug)
结局指标
主要结局
GI-HOPE score representing changes at Day 4/5 with respect to Baseline (Day -1)
时间窗: 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.
次要结局
- Serum GM-CSF(Baseline, Days 1-4)
- Oxygenation(Baseline to Day 11)
- Sequential Organ Failure Assessment (SOFA)(Baseline to Day 11)
- C-reactive Protein(Baseline to Day 11)
- Days on vasoactive drugs(Baseline to Day 28)
- Number of patients with Adverse Events (AE), Serious AEs and Adverse Drug Reactions(baseline to 28 days)
- Acute Physiology and Chronic Health Evaluation (APACHE)(Baseline to Day 11)
- Extravascular Lung Water Index(Baseline to Day 11)
- All cause mortality(Baseline to Day 28)
研究者
研究点 (7)
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