The Molecular Biological Effects of Immunotherapy in the Nose
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- The Total Number of Differentially Expressed Transcripts.
研究概览
简要总结
Allergic rhinitis might be caused by decreased resistance of nasal barrier to allergens and other environmental insults. About 20 % of the European population suffers from pollen allergies. Birch pollen allergic rhinitis is the most common allergic disease in the Scandinavia and it exists widely also in the Central Europe. Suffering and high costs of pollen allergies may be reduced by understanding the molecular biology of the nasal barriers during allergic response. Our aim is to observe the effect of season and birch pollen immunotherapy on the molecular biology of nasal epithelium and the microbiome.
详细描述
This is a controlled study with an intervention arm, and a control group of healthy volunteers. The population is composed of nonsmoking healthy adults and patients having birch or timothy pollen allergy with rhinoconjuctivitis symptoms and without other diseases. The diagnosis of pollen allergy is verified with positive history, skin prick test, and allergen specific IgE antibodies. Subjects undergo a spirometry with a bronchodilatator test and a histamine challenge. Quality of life and patient history data is collected by questionnaires. Four peripheral blood samples, as well as nasal cell swabs from nasal mucosa without local anesthesia are collected from each patient; in spring and winter before the group of the intervention arm starts with birch pollen subcutaneous immunotherapy; and during the first spring and winter when a subgroups has received the birch pollen immunotherapy. We plan to perform the following analyses for the nasal specimens: transcriptomics and their regulators, sequencing of 16SrRNA and RT-qPCR for assessing mucosal microbiome, mass spectrometry for analyses of proteins and protein-protein complexes, immunohistochemistry for tissue level localization and quantitation of proteins, in silico analyses for the data mining, integration and display. In addition we observe the alterations in inflammatory mediators after in vitro allergen activation of purified peripheral blood leukocytes by ELISA and real time qPCR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 12 Years 至 50 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •allergic rhinoconjunctivitis of birch pollen OR healthy controls
排除标准
- •smoking, asthma, any other disease than allergic rhinoconjunctivitis, requiring constant medication
研究组 & 干预措施
subcutaneous immunotherapy
Starts with birch pollen subcutaneous immunotherapy
干预措施: birch pollen subcutaneous immunotherapy (Drug)
结局指标
主要结局
The Total Number of Differentially Expressed Transcripts.
时间窗: -6 months vs. +6 months from the starting point of birch pollen subcutaneous immunotherapy.
Transcriptomics are evaluated By Next Generation Sequencing. The total number of differentially expressed transcripts are defined from nasal epithelial brushing samples taken at -6 months vs. at +6 months in the two subject groups. The subject groups are the Subcutaneous immunotherapy group and No immunotherapy group.
次要结局
- Percentage Change in Visual Analogue Scale Scores of Symptoms(-6 months vs. +6 months from the starting point of birch pollen subcutaneous immunotherapy.)
研究者
Sanna Salmi
MD PhD, Docent
Helsinki University Central Hospital
