Evaluation of Early Clinical and Immunological Efficacy of Specific Immunotherapy to Dust Mites in Children With Asthma
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- clinical symptoms, reliever drugs usage, controller medication usage, quality of life, lung function, chosen markers of inflammation (ECP, specific IgE, specific IgG) induction of regulatory lymphocytes (Treg) - Foxp3 mRNA expression
研究概览
简要总结
The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function, chosen markers of inflammation, induction of regulatory lymphocytes, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SIT in children with asthma.
详细描述
Specific immunotherapy is the only one causal treatment method of atopic diseases including bronchial asthma in children.
The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on clinical symptoms,reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function, chosen markers of inflammation, induction of regulatory lymphocytes, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SIT in children with asthma.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients allergic to house dust mites
- •patients with moderate bronchial asthma
- •patients with controlled asthma
- •patients who were qualified for immunotherapy and gave written informed consent for immunotherapy (active treatment group)
- •patients who were qualified for immunotherapy and did not agree with this kind of treatment - did not give written informed consent for immunotherapy (control group)
排除标准
- •patients allergic for other perennial and seasonal allergens
- •patients with other chronic diseases that either put the patient at risk when participating in the study or 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:anti-parasites or oral corticosteroids within 6 months before the first visit.
结局指标
主要结局
clinical symptoms, reliever drugs usage, controller medication usage, quality of life, lung function, chosen markers of inflammation (ECP, specific IgE, specific IgG) induction of regulatory lymphocytes (Treg) - Foxp3 mRNA expression
时间窗: baseline (first visit), after 3 months (second visit), 12 months (third visit), 24 months (fourth visit)
次要结局
- bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SIT (skin prick tests)(after 24 months from first visit (fourth visit))
研究者
Iwona Stelmach
MD, PhD, Professor
Medical University of Lodz