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临床试验/EUCTR2013-001143-31-DK
EUCTR2013-001143-31-DK进行中(未招募)1 期

TARGETTargeting the small airways in asthma”Does fine particle ICS improve peripheral airway inflammation and function in patients with insufficient response to large particle ICS? - TARGET

Bispebjerg University Hospital0 个研究点目标入组 40 人开始时间: 2013年6月28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
40

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

  • Asthma diagnosed by at least one objective test within last 12 months:
  • ?positive bronchial provocation test (mannitol or methacholine),
  • ?reversibility to beta-2 agonist (> 12 %, and > 250 mL) or
  • ?PEF variation (>20%)
  • 1.Treated with daily ICS +/- LABA for at least 3 months
  • 2.Partly controlled or uncontrolled asthma according to GINA guidelines definitions, and
  • 3.Positive mannitol bronchial provocation test (PD15< 450 mg) at screening and after 4 week run-in.
  • 4.Signs of eosinophilic airway inflammation (FeNO > 25 ppb)
  • 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 40
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1.Other lung diseases
  • 2.Active smoking past 12 months
  • 3.Ex-smokers (< 12 months: > 10 pack years)
  • 4.Pregnancy or lactation
  • 5.Respiratory infection (past 6 weeks)

研究者

发起方
Bispebjerg University Hospital

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