The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Medication Adherence Rating Scale (MARS)
研究概览
简要总结
The management of chronic diseases requires a constant monitoring of treatment adherence, in order to obtain an optimal disease control. However, this is often difficult to achieve, especially in pediatric age.
In this sense, for asthmatic patients treated by Symbicort Turbohaler, "AstraZeneca" developed the "Turbo+", an electronic device attached to the Turbohaler, which allows to feel whether the patient does the inhalation, and to register it on a specific application.
The present randomized trial aims to compare the treatment adherence between asthmatic children/adolescents aged 6-17 years treated with Symbicort Turbohaler plus Turbo+ or Symbicort Turbohaler without Turbo+.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •uncontrolled mild or moderate persistent asthma;
排除标准
- •acute upper respiratory infections;
- •immunological or metabolic systemic disease;
- •major malformations of the upper airways;
- •active smokers.
研究组 & 干预措施
Symbicort Turbohaler plus Turbo+
10 asthmatic children
干预措施: Symbicort Turbohaler plus Turbo+ (Device)
Symbicort Turbohaler without Turbo+
10 asthmatic children
干预措施: Symbicort Turbohaler without Turbo+ (Drug)
结局指标
主要结局
Medication Adherence Rating Scale (MARS)
时间窗: 3 months
Change in the MARS score from baseline to the end of treatment
次要结局
- Childhood Asthma Control Test (C-ACT)(3 months)
- Asthma Control Test (ACT)(3 months)
- Pediatric Asthma Quality of Life Questionnaire (PAQLQ)(3 months)
研究者
Stefania La Grutta, MD
Coordinator of the group "Clinical and Environmental Epidemiology of Pulmonary and Allergic Pediatric Diseases". Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.
Istituto per la Ricerca e l'Innovazione Biomedica