EUCTR2005-005402-22-DE进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, multi-centre Phase I Trial investigating the safety of GRAZAX-R in children aged 5-12 years with grass pollen induced rhinoconjunctivitis (with/without asthma)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
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
- •- Boys and girls 5-12 years of age
- •- A clinical history of grass pollen induced allergic rhinoconjunctivitis requiring treatment during at least one grass pollen season
- •- Positive Skin Prick Test (SPT) response (wheal diameter of at least 3 mm) to Phleum pratense
- •- Positive specific IgE against Phleum pratense (at least 0.7 kU/ml)
- •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
- •- Current food allergies with oral allergy syndrome
- •- A clinical history of severe asthma
- •- At randomisation, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process
- •- Current severe atopic dermatitis
- •- History of anaphylaxis or angioedema
研究者
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