Assessment of Effectiveness and Safety of Annual Sublingual Immunotherapy in Children With Bronchial Asthma and/or Allergic Rhinitis Allergic to House Dust Mites
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical symptoms of asthma and allergic rhinitis and use of rescue medication
研究概览
简要总结
The purpose of the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites.
详细描述
Allergen immunotherapy is currently the only one method of cause treatment of the IgE-dependent allergic diseases. Sublingual immunotherapy (SLIT) is the method which allows to give allergens via alternative oral route in patients home. Due to possibility of avoiding injection this therapy offers better relationship with pediatric patient. However efficacy and safety of sublingual immunotherapy are still important issues, especially in asthmatic children. The purpose of the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites.
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
- •patients with bronchial asthma and/or allergic rhinitis allergic to house dust mites first diagnosed at least 2 years before the study
排除标准
- •active respiratory tract infection requiring antibiotic treatment within 4 weeks before the study
- •hospitalisation due to asthma exacerbation during the 3 months before the first visit
- •known contraindications of SIT according to the EAACI
- •previous allergen immunotherapy
- •use of systemic corticosteroids
- •other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or mental diseases or malignancy that either put the patient at risk when participating in the study or could influence the results of the study
研究组 & 干预措施
Active group
Group of children with bronchial asthma and/ or allergic rhinitis 6-18 years old receiving annually house dust mites sublingual allergen extract
干预措施: sublingual house dust mites allergen extract (Drug)
Placebo group
Group of children with bronchial asthma and/or allergic rhinitis 6-18 years old receiving placebo in sublingual applicator
干预措施: placebo in sublingual applicator (Drug)
结局指标
主要结局
Clinical symptoms of asthma and allergic rhinitis and use of rescue medication
时间窗: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
次要结局
- Change of percent of regulatory lymphocytes in peripheral blood(Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT))
- assessment of inflammatory markers in exhaled breath condensate and FeNO(Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT))
- non-specific bronchial hyperreactivity with methacholine (PC20M), specific conjunctival provocation test(Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT))
研究者
Iwona Stelmach
MD, PhD, Professor
Medical University of Lodz