Evaluate the Therapeutic Effect of Inhaled Corticosteroid in Asthmatic Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- FEV1
研究概览
简要总结
Inhaled corticosteroid (ICS) is considered the first line medication for asthma, however, the therapeutic effect is markedly different even in patients with almost similar clinical manifestations. Our study was designed to explore the clinical and genetic factors that may influence the effectiveness of ICS in asthmatic children.
详细描述
The three major common classes of asthma controller medications include inhaled corticosteroids (ICS), beta-2-agonists and leukotriene antagonists. Among them, ICS was now suggested as the first-line therapy demonstrated in Global Initiative for Asthma guideline updated in 2017.
The response to asthma medication is markedly different even in patients with almost similar clinical manifestations. Despite the wide availability of therapeutic asthma medications and large studies supporting their efficacy, there is significant inter-personal variability in the response to each of the three major classes of asthma medications with a subgroup of patients that have limited disease control, persistent symptoms and exacerbations even under controller medications use. For example, inter-individual variability in therapeutic effectiveness to ICS in both asthma children and adults is significant, with 22 to 60% of patients being classified as non-responders.
Although many factors can contribute to variation in response to therapy effectiveness, such as higher exhaled nitric oxide, higher total eosinophil counts, higher immunoglobulin E, lower forced expiratory volume at one second (FEV1) predicted. and lower concentration of methacholine needed to produce a 20% fall in FEV1 from baseline (PC20), it is still believed that genetic variability can also play an important role. Hence asthma represents a major burden with respect to mortality, morbidity and National Health Insurance costs, searching for appropriate mediations for asthma control is imperative and investigating the effect of genetic variability on therapy response is an important step to develop personalized prescription.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosed by asthma specialists, the age of onset was under 10 years old
排除标准
- •Children with cancer, major immunological diseases, such as systemic lupus erythematosus (SLE) or Henoch-Schonlein purpura (HSP), rare hereditary diseases, or under severe infection.
- •Children who received ICS or oral steroid in recent 4 weeks
研究组 & 干预措施
NTUH
National Taiwan University Hospital, all participants receive Duasma (budesonide, 200mcg/puff)
干预措施: Budesonide/Cisclesonide (Drug)
FJUH
Fu Jen University Hospital, all participants receive Duasma (budesonide, 200mcg/puff)
干预措施: Budesonide/Cisclesonide (Drug)
CGH
Cathay General Hospital, all participants receive Alvesco (Ciclesonide, 160mcg/puff)
干预措施: Budesonide/Cisclesonide (Drug)
结局指标
主要结局
FEV1
时间窗: 1 month
change of forced expiratory volume at one second (FEV1) from baseline
次要结局
- Asthma control test(1 month)
- exhaled nitric oxide (eNO)(3 months)
- PEF(1 month)
- Serum biomarkers(3 months)
