Follow up Study 5-6 Years After ILIT With 2 Concomitant Allergens, Birch and Grass
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- Nasal grass allergen provocation
研究概览
简要总结
52 patients that had previously participated in the RDBPC study of intralymphatic immunotherapy (ILIT) with 2 concomitant allergens, birch and grass, with NCT02423707, were eligible for an open follow up 5-6 years after treatment.
详细描述
Bakground: Intralymphatic immunotherapy has been proposed as a new, more effective, modality for allergy immunotherapy. With ultrasound- guided injections into the lymph node the allergen is injected directly to the secondary lymphoid organ to stimulate the immune system. The protocol that has been used so far is three injections with one month interval. The effect have been evaluated in several studies with limited sample sized and the effect have been estimated to be in the same range as after conventinal subcutaneous immunotherapy. No long term follow up have been performed.
Objective
To investigate if the clinical improvement and immunological alterations is maintained 5-6 years after ILIT with two concomitant allergens, birch and grass.
Methods: 52 patients that had previously participated in the RDBPC study were asked to participate in this open follow up.
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
- None
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
- •Moderate to severe allergic rhinitis to birch and grass pollen defined with a positive skin prick test and elevated allergen specific IgE antibodies
排除标准
- •uncontrolled or perennial asthma
- •other pulmonary disease
- •known autoimmune or collagen disease
- •chronic infection
- •other significant disease
- •severe atopic dermatitis
- •use of beta blockers or angiotensin converting enzyme inhibitors as antihypertensive medications
- •symptomatic sensitization to house dust mite or furry animals with daily exposure
- •chronic upper airways disease
- •pregnancy
- •obesity with BMI >30
- •withdrawn informed consent
研究组 & 干预措施
Active ILIT treated
Patients that have received ILIT with birch and grass allergen 5-6 years previously
干预措施: ALK Alutard 5-grasses and birch (Drug)
Non- AIT treated
Patients that have received placebo ILIT 5-6 years previously and patients with birch and grass pollen induced allergic rhinitis that have not previously been treated with allergen immunotherapy (AIT).
干预措施: ALK Diluent (Drug)
结局指标
主要结局
Nasal grass allergen provocation
时间窗: 5-6 years after active or placebo ILIT
The symptoms are recorded during 30 minutes after nasal spray with grass allergen
次要结局
- Allergen specific IgE(5-6 years after active or placebo ILIT)
- Allergen specific IgG4(5-6 years after active or placebo ILIT)
- Nasal birch allergen provocation(5-6 years after active or placebo ILIT)
- Combined symptoms and medciations score(Pollen season 5-7 years after active or placebo ILIT)
- Rhinoconjunctivitis quality of life questionnaire(Pollen season 5-7 years after active or placebo ILIT)
- Sinonasal outcome test quality of life questionnaire(Pollen season 5-7 years after active or placebo ILIT)
- T-cell and basophil activation(5-6 years after active or placebo ILIT)
研究者
Lars Olaf Cardell
Professor
Karolinska Institutet