EUCTR2006-003006-26-FR进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, multi-national, multi-centre, Phase IIIpaediatric study of the efficacy and safety of 300 IR sublingual immunotherapy (SLIT)administered as allergen-based tablets once daily to children suffering from grasspollen rhinoconjunctivitis
Stallergenes S.A.0 个研究点目标入组 350 人开始时间: 2006年10月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
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
- •1. Male or female patients aged 5 to 17 years (inclusive); outpatients.
- •2. Written consent / assent (as applicable).
- •3. Grass pollen-related allergic rhinoconjunctivitis for the last two pollen seasons.
- •4. Sensitised to grass pollen (positive skin prick test and grass pollen-specific IgE level of at least Class 2).
- •5. Total symptom score on the RRTSS during the previous pollen season of greater than or equal to 12.
- •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
- •Patients with symptoms of rhinoconjunctivitis during the grass pollen season due to
- •sensitisation to allergens other than grass pollen must not be included. Patients
- •must be asymptomatic to all other allergens during the grass pollen season.
- •Patients who have allergic rhinitis due to perennial allergen may not be included.
- •Asthma requiring treatment other than beta-2 inhaled agonists.
- •Patients who have received any desensitisation treatment for grass pollen.
- •Treatment by immunotherapy with any other allergen within the previous 5 years or ongoing.
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