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临床试验/NCT03487809
NCT03487809招募中不适用

Evaluate the Therapeutic Effect of Inhaled Corticosteroid in Asthmatic Children

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年10月22日最近更新:
适应症
干预措施
相关药物

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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