NCT01115595已完成4 期
Efficacy of Mite Allergen Vaccine Among Thai Patients With Allergic Rhinitis
Pongsakorn Tantilipikorn1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2010年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Total nasal symptoms score
研究概览
简要总结
The purpose of this study is to study the efficacy of allergen injection immunotherapy for allergic rhinitis by
- symptoms score
- medication score
- quality of life
- immunologic test from blood
详细描述
Compare the efficacy of allergen injection immunotherapy between the treatment group and the placebo group after injection for
- 2 months
- 6 months
- 12 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with the symptoms of allergic rhinitis who sensitized to mite (Dermatophagoides pteronyssinus)
- •positive skin prick test to D.p. at 4+ degree
排除标准
- •steroid dependent asthma
- •force expiratory volume (FEV1) less than 70% of predicted value
- •previous injection immunotherapy within 2 years
- •pregnancy
- •medical conditions such as ischemic heart disease, autoimmune disease, cancer, previous history of anaphylaxis
研究组 & 干预措施
Intervention
Active Comparator
injection by Mite extract with standard allergic medication (oral antihistamine and/or topical nasal steroid)
干预措施: Intervention (Biological)
Control Group
Other
Injection by buffer solution WITH standard allergic medication (oral antihistamine and/or topical nasal steroid
干预措施: Control (Other)
结局指标
主要结局
Total nasal symptoms score
时间窗: average within 1 week
3 point scale (0,1,2,3) and combination of * nasal block * rhinorrhea * itching * sneezing
次要结局
- Combined total symptoms score and medication score(average within 1 week)
研究者
Pongsakorn Tantilipikorn
Associate Professor Dr.
Mahidol University
研究点 (1)
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