EUCTR2009-014904-73-DE进行中（未招募）不适用
Open label clinical trial to determine the blood ethanol concentration following repeated administration of Bronchicum Elixir to children (1 to 12 years) with acute bronchitis.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
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
- •-children between the age of 1 and 12 years
- •-diagnosis of acute bronchitis (according to bronchitis severity score, BSS = 5)
- •-written informed consent of the patient's parents to participate
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •-Obstructive or non-obstructive chronic bronchitis
- •-Allergic bronchial asthma
- •-Parallel treatment with antibiotics, glucocorticoids, beta-mimetics
- •-theophylline, expectorants or antitussives or any treatment with this type of medication during 7
- •days before trial start (antibiotics: 4 weeks before trial start)
- •-indication for treatment with antibiotics (fever of = 39°C)
- •-known sensitivity to the ingredients of the investigational product
- •-pathological laboratory findings, any severe organ- or systemic disease
- •- the exclusion of minors, who have been committed to a youth institution by
- •official directive or judicial order.
- •-simultaneous participation in another clinical trial or participation in a clinical trial during 4 weeks
- •before start of this clinical trial
- •-inability to comply with study protocol
研究者
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