跳至主要内容
临床试验/EUCTR2014-004748-37-Outside-EU/EEA
EUCTR2014-004748-37-Outside-EU/EEA进行中(未招募)不适用

Korean Study of Real-world” Montelukast Use in Mild Asthmatic Children with Concomitant Allergic Rhinitis - Montelukast Use in Mild Asthmatic Children with Allergic Rhinitis

MSD Korea LTD.0 个研究点目标入组 200 人开始时间: 2015年4月3日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • a. Patients’ caregiver understands the study procedures and agrees to
  • participate by signing the appropriate informed consent form.
  • b. Patient is a male or female and between the ages of 2 and 14 years
  • (inclusive) at Visit 1.
  • c. Patients diagnosed with asthma, classified as mild persistent asthma
  • according to GINA guidelines at the time of inclusion.
  • d. Patients diagnosed with comorbid allergic rhinitis.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 191
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • a. Prior treatment with high dose ICS (i.e., requires a dose higher than beclomethasone dipropionate 400 µg per day, or equivalent), other medications used in severe cases.
  • b. Patients with suspected rhino-sinusitis (i.e., fetid breathing, mucopurulent nasal discharge, post nasal drip, X-ray finding etc.)
  • c. Patients with cystic fibrosis, congenital heart disease.
  • d. Patients with Chinese medication use at inclusion.
  • e. Inappropriate patients with investigator judgment.

研究者

发起方
MSD Korea LTD.

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