跳至主要内容
临床试验/EUCTR2005-001466-14-GB
EUCTR2005-001466-14-GB进行中(未招募)1 期

A Proof of Concept Study to Investigate the use of Simvastatin as a Putative Anti-inflammatory Agent in Asthma - Simvastatin in Asthma

niversity of Dundee0 个研究点目标入组 20 人开始时间: 2005年4月19日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
20

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

  • Adult asthmatics (over 18 years) with stable mild to moderate asthma.
  • FEV1 > 60%
  • FENO > 20ppb
  • MCh PC10 < 2mg/mL
  • Induced sputum eosinophil count >3%
  • Ability to perform tests and remain compliant with protocol
  • Good inhaler technique
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Potential or actual contra-indication to Simvastatin in particular liver disease, renal failure, current or previous excess alcohol intake, elevated CK, pregnancy and concomitant use of medications known to interact adversly with simvastatin.
  • Known or suspoected hypersensitivity to any of the other IMP's
  • Inability to to provide informed consent
  • Recent respiratory tract infection
  • Recent use of oral corticosteroids
  • Significant concomitant respiratory disease
  • Current smokers
  • Any other condition that may, in the opinion of the investigators, endanger the health or safety of the participant

研究者

发起方
niversity of Dundee

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