Evaluation of Clinical and Immunological Parameters in Children Treated With Subcutaneous Immunotherapy Towards Pollen - a Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Response to a Conjunctival Allergen Challenge
研究概览
简要总结
The objective is to prospectively explore associations between immunological parameters in blood and clinical effect of subcutaneous immunotherapy (SCIT) in children with severe allergy towards pollen. Half of the children will receive SCIT while the other half will start SCIT after the study is finished. Clinical evaluations of symptoms and an immunological survey will be performed before start of SCIT and after one year of treatment. Some of the immunological parameters will also be checked after 6 months of treatment
详细描述
Before start of SCIT, with Alutard pollenextract/s from " Allergologisk Laboratorium Köbenhavn" (ALK), and after one year of treatment, immunoglobulin E (IgE)-antibody levels towards the crude allergen and important allergen components in birch and grasspollen (timothy) will be measured in blood. While IgE- antibodies are considered to be an indicator of allergy IgG- and IgG4-antibodies are considered to be "blocking" antibodies in IgE-mediated allergy. Therefore the investigators will measure the IgG- and IgG4-antibody levels to crude allergens and applicable allergen components before start, when maintenance dose is reached (after 6 months) and after one year of treatment. In order to evaluate quality of life, a validated form (DISABKIDS) will be used. Symptom score will be rated by a validated form (LILA). The need for medication to treat allergic rhinitis and asthma will be assessed using questionnaires. A conjunctival provocation with the applicable allergen(s) will be performed before start of SCIT and after one year of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Seasonal Rhinoconjunctivitis caused by grass and/or birch pollen allergy
- •Insufficient clinical effect of symptomatic treatment (antihistamine, nasal corticosteroids)
- •IgE antibodies to grass and/or birch pollen antigens
排除标准
- •severe comorbidity, severe asthma, pregnancy
研究组 & 干预措施
Treatment group
Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy
干预措施: Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy (Drug)
Control group
No immunotherapy, symptomatic treatment These patients will only receive symptomatic treatment for their allergic rhinoconjunctivitis.
干预措施: No immunotherapy, symptomatic treatment (Other)
结局指标
主要结局
Response to a Conjunctival Allergen Challenge
时间窗: Before treatment and after 12,24 and 36 months
Change in the dose of allergen needed to elicit a clinical response following ocular administration of the allergen
次要结局
- Questionnaire regarding use of pharmacologic treatment for allergy and asthma during pollen season(Baseline and after 12,24 and 36 months of immunotherapy)
- PADQLQ (pediatric allergic disease quality of life questionnaire) in Swedish LILA(Baseline and after 12,24 and 36 months of immunotherapy)
- Change in level of IgG4-antibodies(Baseline and after 12,24 and 36 months of immunotherapy)
- Questionnaire regarding quality of life(Baseline and after 12,24 and 36 months of immunotherapy)
- Change in level of IgE-antibodies(Baseline and after 12,24 and 36 months of immunotherapy)
- Change in level of IgG-antibodies(Baseline and after 12,24 and 36 months of immunotherapy)
研究者
Maria Ingemansson
Principal Investigator
Karolinska Institutet