A One Year Trial Evaluating the Safety and Efficacy of the ALK House Dust Mite Allergy Tablet
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 992
- 试验地点
- 2
- 主要终点
- Evaluation of allergy symptoms and use of symptomatic medication
研究概览
简要总结
The primary aim of this trial is to evaluate the efficacy of the ALK house dust mite tablet given once daily compared to a placebo tablet in the treatment of house dut mite allergic rhinits.
Additionally the secondary objective of the trial is to evaluate the safety and tolarability of the ALK house dust mite tablet.
Immunotherapy has been shown to provide therapeutic benefits to subjects with house dust mite induced allergy. This trial is planned to investigate if clinically relevant improvements in rhinitis symptoms and with less use of symptomatic medication can be obtained in subjects with a history of poor didease control despite of use of symptomatic medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A history of house dust mite allergy
- •Use of symptomatice medication for treatment of house dust mite allergy
- •Positive skin prick test to mites
- •Positive specific IgE
排除标准
- •History of uncontrolled asthma
- •Overlapping symptomatice allergies
- •Previous treatment with immunotherapy
结局指标
主要结局
Evaluation of allergy symptoms and use of symptomatic medication
时间窗: 1 year with treatment
Comparing the daily recording of symptoms and use of symptomatic medication during the last period of the trial between the actively treated patients and the placebo treated.
次要结局
未报告次要终点