EUCTR2004-002350-63-DE进行中（未招募）不适用
Efficacy and Safety of Sublingual Immunotherapy with Ultra-Rush Titration in Children with Allergic Rhinoconjunctivitis to Tree Pollen, a Multicentre DBPC Trial - SLIT Efficacy Children
Stallergenes GmbH & Co.KG0 个研究点目标入组 240 人开始时间: 2004年10月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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
- •Female or male patients aged 6 - 14 with allergic rhinitis and/or allergic rhinoconjunctivitis
- •Clinical sensitisation to tree pollen (birch and possible alder and/or hazel) Sensitisation to further aeroallergens and to mites, cat and dog and further seasonal allergic rhinitis and seasonal mild or moderate allergic asthma are considered as not relevant
- •Positive clinical history of tree pollen (birch and possible alder and/or hazel), proven by:
- •- the majority of clinical symptoms appearing duringthe appropriate season for birch pollen (and possible alder and/or hazel pollen season);
- •- positive skin prick test (wheal diameter > 3 mm) and presence of specific IgE (positive CAP RAST class II and above);
- •- planned antiallergic or antiasthmatic treatment with the following drugs: local Levocabastine (nose, eye) oral Cetirizine, nasal Fluticasone;
- •Total symptom score on the RRTSS during the previous pollen season of greater than or equal to 8
- •Compliant patient (respectively the parents or the legal guardians of the patient) being able to complete a diary card for self evaluation of the symptoms and antisymptomatic medication
- •Signed and dated Patient’s informed consent for patients aged 12 and older as well as an signed and dated informed consent by the parents or legal guardians
- •Safety laboratory results within the normal range or considered as not clinically significant.
- •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
- •Previous immunotherapy with hazel pollen, alder pollen and/or birch pollen extracts within the last 3 years
- •Perennial allergic rhinitis
- •Perennial allergic asthma
- •Simultaneous participation in other clinical trials
- •Other reasons contra-indicating an inclusion into the trial according to the Investigator’s estimation (poor compliance)
- •Active tuberculosis
- •Auto - immune disorders
- •Severe chronic-inflammatory diseases
- •Irreversible secondary disorders at the target organ (emphysema, bronchoectasis)
- •Patients treated with b-blockers
研究者
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