Tolerability and Side Effects for a New Device in Specific Immunotherapy for Allergic Child
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- prevalence of pain
研究概览
简要总结
The recent interest that the Specific Immunotherapy (ITS) has aroused is due to the positive potential role that could be played, in particular in the forms of allergic asthma, because this method constitute the only intervention (unlike that pharmacologic) able to act on the same causes of the disease, altering the natural history. To achieve this the investigator has tried to use the specific subcutaneous immunotherapy (SCIT), to which there are studies that, with scientific rigor, have demonstrated the benefits.
详细描述
The Investigator proposes to compare, in children with allergic rhinitis and / or allergic asthma to grasses, the pain caused by the administration of the Specific Immunotherapy (ITS) via epicutaneous with autoinjector (INJEX) pressure without needle vs. the traditional subcutaneous immunotherapy (SCIT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from both parents / legal guardian;
- •Of both sexes;
- •Between the ages of 5 to 18 sensitized to grasses Awareness for grasses will be established with prick test;
- •Rhinitis established according to the ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines and / or stage 1 or 2 Asthma according to GINA classification (Global Initiative for Asthma)
- •It may, or not, be going on ITS with s.c. administration
排除标准
- •Children under age 5 and age> 18 years;
- •Autoimmune diseases and immunodeficiencies;
- •Neoplasms;
- •Severe psychological problems;
- •Treatment with β-blockers;
- •Poor compliance, including language training;
- •Severe asthma uncontrolled by medication or irreversible airway obstruction (FEV1 less than 70% of the predicted value);
- •Severe cardiovascular diseases in which may be hazardous in the administration of adrenaline
结局指标
主要结局
prevalence of pain
时间窗: monthly for 6 month
questionnaire of the pain scale monthly at each seat vaccination soon after every administration : the Wong-Baker scale for children aged 3 to 8 years and the classical analogue scale from 8 years and 1 day to 18 years.
次要结局
- Incidence of procedure adverse events(6 month)
- prevalence of pain(20 minutes after every administration)
研究者
Mariella Enoc
President
Bambino Gesù Hospital and Research Institute