Changes in Specific Immunoglobulin and Blood Basophil Activity During Subcutaneous Immunotherapy in Patients With Allergic Rhinitis Due to Grass Pollen Allergy - a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- a significant decrease in basophil activity during and after treatment
研究概览
简要总结
The trial is randomized prospective study to examine the effects of subcutaneous immunotherapy on the adaptive immune system. The trial includes 30 participants randomized to treatment or control group. The effect measures are changes in the basophil activity and biology as well as changes in plasma cells during and after treatment. Clinical outcome is assessed by QoL questionnaires and clinical testing.
Hypotheses:
- changes in plasma cells correlate to changes in immunoglobulins and effector cell responses
- the reduction of inflammation due to SCIT has influence on the effector cell responses
- changes in paraclinical measurements can be related to clinical findings
详细描述
The investigators are recruiting 30 participants, which are randomized to receive SCIT (24) or no treatment (6) The following will be measured
- the development of immunoglobulin response
- plasma cells under updosing phase
- changes in basophil activity under updosing and maintenance treatment
- subtyping of allergic sensitization
- clinical outcome and quality of life
- changes in mast cells in the nasal mucosa
- changes in the cell biology of the basophils
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •rhinoconjunctivitis due to grass pollen allergy
- •positive skin prick test and nasal allergen challenge test to grass pollen extract
排除标准
- •severe comorbidity, severe asthma, pregnancy
研究组 & 干预措施
alutard phl.prat., treatment group2
basophil activity, basophil biology measured
干预措施: Alutard phl prat (Drug)
alutard phl prat. treatment group
18 subjects receiving active treatment: basophil activity, plasma cells and immunoglobulins measured
干预措施: Alutard phleum pratense subcutaneous immunotherapy (Biological)
alutard phl prat. treatment group
18 subjects receiving active treatment: basophil activity, plasma cells and immunoglobulins measured
干预措施: Alutard phl prat (Drug)
alutard phl.prat., treatment group2
basophil activity, basophil biology measured
干预措施: Alutard phleum pratense subcutaneous immunotherapy (Biological)
结局指标
主要结局
a significant decrease in basophil activity during and after treatment
时间窗: every 3 weeks for 3 months, then 3 monthly for 3 years
次要结局
- reduction in high affinity IgE receptor density on basophils and mast cells(at inclusion and at the end of study)
- clinical outcome: reduction in the reaction to allergen challenge tests (skin and nose), significant better outcome in quality of life questionnaires and symptom/medication scores(once yearly for 4 years)
- a significant increase in the number of plasma cells during up dosing(5 times during the first 3 months of the study)
- a significant shift in specific immunoglobulins from IgE at start to IgG1 and IgG4 after treatment. allergen epitope specific IgE and IgG4(every 3 months for 4 years)
研究者
Pia Pedersen
MD
Aarhus University Hospital