NCT01627613已完成2 期
Proof of Concept Study in Male and Female Intensive Care Patients to Investigate the Clinical Effect of Repetitive Orally Inhaled Doses of AP301 on Alveolar Liquid Clearance in Acute Lung Injury
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
- 40
- 试验地点
- 1
- 主要终点
- change in extravascular lung water within 7 days of treatment
研究概览
简要总结
The purpose of this study is to assess the effect of orally inhaled AP301 on alveolar liquid clearance in ALI (acute lung injury) patients with the purpose to assess the treatment associated changes of extravascular lung water (EVLW) within 7 days of treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •intubated and mechanically ventilated male and female patients of the Intensive Care Units of the Department of Anesthesia, General Intensive Care and Pain Control
- •meets the criteria of ALI (as defined by the American-European Consensus Conference on ALI/ ARDS):
- •Onset of ALI within 48 hours
- •Bilateral infiltrates seen on frontal chest radiograph
- •PCWP ≤ 18 mm Hg or no clinical evidence of left atrial hypertension
- •paO2/ FiO2 ratio ≤ 300 mm Hg
- •EVLW in PiCCO® at screening ≥ 8 ml/PBW
- •Meeting criteria for extensive hemodynamic monitoring according to investigators discretion
- •ICU Patients being mechanically ventilated and are stable in this condition for at least 8 hours
- •Negative pregnancy test and adequate contraception in female patients of childbearing potential
- •Informed consent:
- •For patients that are temporarily unable to consent (e.g. comatose patients) a subsequent informed consent has to be provided.
排除标准
- •History of clinically relevant allergies or idiosyncrasies to AP301 or any other inactive ingredient(s) of the investigational product
- •Brainstem death at screening
- •Current evidence of septic shock as defined by the Surviving Sepsis Campaign (Presence of acute organ dysfunction secondary to infection plus hypotension with systolic blood pressure < 90 mm Hg or mean arterial pressure (MAP) < 70 mm Hg for not less than one hour which cannot be reversed with fluid resuscitation)
- •Neutrophil count <0.3 x 109 L
- •Patients under immunosuppression: high dose steroids (> 80 mg Prednisolone /d; > 300 mg hydrocortisone / d), cancer treatment (chemotherapy or biological) or therapy with other immunosuppressive agents for organ transplantation within 2 weeks
- •BMI < 18.5 or > 35
- •Cardiogenic pulmonary edema diagnosed by echocardiography or pulmonary artery catheter
- •Pregnancy / lactation or intention to fall pregnant during the time course of the study
- •Women of childbearing potential as well as men of procreative capacity who are not using adequate contraception
- •Participation in other interventional drug trials
研究组 & 干预措施
AP301
Experimental
Treatment group
干预措施: AP301 (Drug)
saline solution
Placebo Comparator
Placebo group
干预措施: Saline solution (Drug)
结局指标
主要结局
change in extravascular lung water within 7 days of treatment
时间窗: change from baseline - day 7
EVWL (measured with PiCCO® technique) until day 7 of treatment (AUC)
次要结局
- ventilator plateau pressure(baseline - day 7)
- Murray Lung Injury Score(baseline - day 7)
- Ventilation parameters / lung function(baseline - day 7)
- Presence/absence/severity and duration of adverse effects - number and severity of adverse events (AEs), serious adverse events (SAEs) and suspected unexpected serious adverse events (SUSARs))(baseline - day 7)
- Oxygenation index(baseline - day 7)
研究者
研究点 (1)
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