Intralymphatic Specific Immunotherapy - as a New Treatment Form for Grass-pollen Allergic Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- symptom improvement
研究概览
简要总结
The purpose of the study is to try a new route for specific immunotherapy (SIT). The current treatment form for SIT is subcutaneously (SCIT), which is a long treatment with up to 50 injections subcutaneously in the upper arm.
The investigators believe that there is additional effect if the allergen is injected directly into the lymph node, since it is here, the allergen presentation is happening. The trial has been performed in Switzerland with significant effect of only three injections of grass-allergen into a lymph node (Clinicaltrials.gov; NCT00470457).
The investigators would like to see what happens if the the dose is doubled, so the patients will receive 6 injections all in all, with the same amount of allergen as the earlier study (1000 SQ-U). Also the outcome measurements is slightly different as the patients will note their symptoms in a diary.
The patients will be divided into three groups using allocation:
1 group with 6 injections of allergen
1 group with 3 injections of allergen and 3 injections of placebo
1 group with 6 injections of placebo. The trial will be double blinded.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •grass pollen allergy through at least 2 seasons
- •positive skin prick test
- •positive Specific IgE of at least
- •Signed informed consent
- •for females a negative pregnancy test.
排除标准
- •out of age limits
- •rhinoconjunctivitis all year round.
- •uncontrolled seasonal asthma
- •patients treated with steroids continuously or beta-blockers.
- •pregnancy and breastfeeding
- •HIV, Hepatitis B+c, and other immunological diseases.
- •psychiatric disease
- •treatment with SCIT or SLIT within the last 5 years
- •participation in other clinical trials within the last 3 months.
结局指标
主要结局
symptom improvement
时间窗: 2 seasons. (2 years)
The patients will fill out a diary during the grasspollen-season before and after treatment. Also they will fill out a form for the general status of the season passed.
次要结局
- Improvement of reactivity of skin prick test and Specific IgE(2 years)
研究者
Professor, Dr. Med Hans-Joergen Malling
Professor Dr. Med.
Rigshospitalet, Denmark