Comparison of Effectiveness and Safety of Sublingual Immunotherapy in Children With Allergic Rhinitis Allergic to Grass Pollen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical symptoms of allergic rhinitis (Pediatric Quality of Life Questionnaire)
研究概览
简要总结
The purpose of the trial is to compare the efficacy and safety of sublingual seasonal and annual immunotherapy in children with allergic rhinitis allergic to grass pollens.
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 the possibility of avoiding injection this therapy allows to have better relationship with patient, and reduce the costs of therapy thanks to reducing the numbers of visits in out-patient clinic.However efficacy and safety of sublingual immunotherapy are still important issues, especially in children.
The purpose of trial is to compare the efficacy and safety of sublingual seasonal and annual immunotherapy in children with allergic rhinitis allergic to grass pollens.
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
- •Children with seasonal allergic rhinitis, allergic to grass pollens, first diagnosed at least 2 years before inclusion into the study
排除标准
- •Active upper respiratory tract infection within 3 weeks before the study and acute sinus disease requiring antibiotic treatment within 1 month before the study
- •Allergic rhinitis hospitalisation during the 3 months before the first visit.
- •Additional criteria were other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or psychiatric diseases or malignancy 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.
- •Excluded medications were systemic corticosteroids.
- •Patients who were receiving immunotherapy were also excluded.
结局指标
主要结局
Clinical symptoms of allergic rhinitis (Pediatric Quality of Life Questionnaire)
时间窗: Following visits after starting the study: at 6 months, 9 months, 12 months, 18 months, 21 months, 24 months.
Visit 2 (6 months after starting the study), visit 3 (9 months after starting the study), visit 4 (12 months after starting the study), visit 5 (18 months after starting the study), visit 6 (21 months after starting the study), visit 7 (24 months after starting the study).
次要结局
- Change of percent of regulatory lymphocytes in the peripheral blood.(at baseline and at the end of the second season (22 months interval))
- non-specific bronchial hyperreactivity with methacholine (PC20M), specific nasal provocation test.(at the end of the first and second season of the study (12 months interval))
研究者
Iwona Stelmach
Head of the Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, MD, PhD, Prof.
Medical University of Lodz