The Effect of Glucocorticosteroid and Vitamin D3 Administration and Montelukast Treatment on Early Clinical and Immunological Effect of Allergen-Specific Immunotherapy in Asthmatic Children, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Regulatory T cell (CD4+CD25+Foxp3 positive) induction measured in peripheral blood mononuclear cells
研究概览
简要总结
There is mounting evidence that successful allergen immunotherapy (SIT) functions through the induction of different subset of Treg including Foxp3 positive cells, therefore additional strategies to enhance this property are highly attractive. Based on previous findings we assumed that combine allergen immunotherapy with non-specific treatments such as glucocorticosteroids and vitamin D3 as well as montelukast sodium treatment might enhanced allergen tolerance induction and improved clinical effectiveness of allergen-specific immunotherapy
详细描述
There is mounting evidence that successful allergen immunotherapy (SIT) functions through the induction of different subset of Treg including Foxp3 positive cells, therefore additional strategies to enhance this property are highly attractive. Since corticosteroids directly induce the development of an IL-10-synthesizing regulatory T-cell population (Tr1) and this effect can be greatly increased with vitamin D3 treatment we , we assumed that combine allergen immunotherapy with non-specific treatments such as glucocorticosteroids and vitamin D3 as well as montelukast sodium treatment might enhanced allergen tolerance induction and improved clinical effectiveness of allergen-specific immunotherapy, therefore we conducted the stud comparing the effect of glucocorticosteroid, glucocorticosteroid with vitamin D3 or montelukast sodium on early immunological and clinical effect of allergen-specific immunotherapy in asthmatic children.
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
- Triple (Participant, Care Provider, Investigator)
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
- •allergic asthma with regular symptoms requiring long-term treatment with inhaled corticosteroids
- •disease duration of at least 2 years
- •sensitisation only to house dust mites
- •resting FEV1 of more or equal 70%
排除标准
- •sensitization to allergens other than house dust mites
- •discontinuation of SIT from any reasons
- •need of a daily dose below 200 or above 800 mcg of budesonide or equivalent
- •other chronic disease including vitamin D3 deficiency and/or resistance which could influence the results of the study or the patient's ability to participate in the study as judged by the investigator
- •medications that resulted in patient exclusion included: inhaled long acting β2-agonist, leukotriene modifiers, β-blockers (eye drops included) or oral corticosteroids within 6 month before the pre-study visit.
研究组 & 干预措施
I
干预措施: prednisone, lactose (Drug)
II
干预措施: prednisone, colecalciferol, lactose (Drug)
III
干预措施: lactose (Drug)
A
干预措施: montelukast sodium (Drug)
B
干预措施: lactose (Drug)
结局指标
主要结局
Regulatory T cell (CD4+CD25+Foxp3 positive) induction measured in peripheral blood mononuclear cells
时间窗: First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy)
次要结局
- Cytokine (IL-10, TGF-beta1, IL-4, IL-5, IL-13) determination in supernatants from peripheral blood mononuclear cells culture.(First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy))
- diary card evaluation with asthma free days estimation, lung function measurement and analysis of reduction of the inhaled corticosteroids dose(Visit first and third visit (after 12 months of immunotherapy))