EUCTR2006-003258-98-CZ进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, multi-national, multi-centre, Phase III study to assess the long term efficacy, carry-over effect and safety of two dosing regimens of 300 IR sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily to patients suffering from grass pollen rhinoconjunctivitis
Stallergenes S.A.0 个研究点目标入组 780 人开始时间: 2006年8月25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
- 780
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
- •Male or female outpatients aged 18 to 50 years (inclusive).
- •Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
- •Sensitised to grass pollen (positive skin prick test and IgE level of at least Class 2).
- •Total symptom score on the Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) during the previous pollen season of greater than or equal to 12 out of a possible score of 18.
- •Female patients of childbearing potential must be willing and able to sign written informed consent stating that they will use appropriate contraception and not plan a pregnancy for the first 3 years of this study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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 may 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 desensitisation treatment for grass pollen.
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