EUCTR2014-000097-19-DE进行中（未招募）1 期
Open, comparative, randomized study on the efficacy, safety and bioavailability of highly concentrated inhaled epinephrine (4 mg L-epinephrine / ml, Infectokrupp® Inhal) versus epinephrine autoinjector application (Fastjekt® Junior) in infants with acute anaphylactic reaction during a food provocation
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •(Inclusion criteria) run-in phase:
- •Written consent of the parents in the study participation
- •Age: 1 to 6 years of age
- •Weight 7,5 to 30kg
- •Planned inpatient admission under a medically indicated oral food challenge
- •(Inclusion criteria) Treatment phase:
- •anaphylactic reaction during the oral food challenges, defined by:
- •(1) at least two affected organ systems (skin, gastrointestinal tract, respiratory tract, and / or heart / circulatory system) with an anaphylaxis symptom score of at least 5 points or
- •(2) peripheral or central airway obstruction or
- •o (3) drop of blood pressure (reduced systolic blood pressure 70 mm Hg plus 2 x age in years or drop of blood pressure:> 30% drop in systolic blood pressure value)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Acute feverish infection
- •- Known clinically significant cardiovascular disease such as angina pectoris, obstructive cardiomyopathy, arrhythmia, diseases of the coronary arteries, the heart muscle, sclerotic vascular changes, cor-pulmonale or atherosclerosis and clinically relevant hypertension
- •- known clinically relevant diabetes
- •- Known hypercalcemia or hypokalemia
- •- Known hyperthyroidism
- •- Familiar pheochromocytoma
- •- Known severe renal dysfunction or bladder dysfunction with urinary retention
- •- familiar narrow-angle glaucoma
- •- Known other serious diseases which not allows a participation in the clinical trial in the opinion of the investigator
- •- known presence of other contraindication according to SmPC(s) of the investigational medicinal product used (Infectokrupp® Inhal, Fastjekt® Junior), in particular if a contraindicated concomitant medication is used (see below)
- •- A history of hypersensitivity reactions to ingredients of the IMP used, in particular sodium metabisulphite
- •- Preceding participate in this study
- •- Participation in a clinical trial during the last 30 days
- •- inability of the parents to understand the study instructions; obvious unreliability or lack of cooperation of the parents
- •- application / taking one of the following contraindicated concomitant medications or therapies:
- •- beta blockers or alpha-blockers
- •- digitalis, Chinidine, halothane or cyclopropane
- •- levodopa, parasympatholytics (e.g. atropine)
- •- sympathomimetic, e.g. orciprenaline
- •- tri- and tetracyclic antidepressants
- •- Monoamine oxidase inhibitors
- •- guanethidine, L-thyroxine
- •- oxytocin, ornipressin, carbazochrome
- •- insulin, antidiabetics
- •- reserpine, mecamylamine
- •- Certain antihistamines: diphenhydramine, chlorpheniramine
- •- pharmaceuticals which causes potassium loss: e.g. diuretics which reduces potassium: aminophylline or theophylline
- •- pharmaceutical preparations containing alcohol
- •- antihistamines or leukotriene receptor antagonist during the last 72 hours
- •- Long-acting beta-2-agonists, or theophylline during the past 48 hours
- •- unwilling to consent to saving and propagation of pseudonymised medical data for study reasons
- •- Subjects who are legally detained in an official institution
- •- Subjects and their parents who are in a dependent relationship with the Investigator or the Sponsor
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