跳至主要内容
临床试验/EUCTR2005-005874-65-BE
EUCTR2005-005874-65-BE进行中(未招募)不适用

on-invasive monitoring of airway inflammation in asthmatic patients during adaptation of inhaled steroid therapy

niversity Hospital Antwerp0 个研究点目标入组 40 人开始时间: 2006年1月11日最近更新:
适应症

试验速览

阶段
不适用
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

  • -Informed consent
  • -Male and female patients between 18 and 65 years
  • -Established diagnosis of asthma at least 3 months before the start of the study and based on: documented reversible airway obstruction of >= 9% of predicted or documented positive metacholine provocation test
  • -Treatment with Symbicort 160/4.5 2*2 during the last 2 months
  • -Clinical stable patients with asthma symptoms < 1 a week, no nocturnal symptoms, PEF variability < 20%
  • -Patients are able to use Symbicort T (and Bricanyl T) correctly
  • -Patients are able to use Peak flow measurements correctly
  • 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) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • -Patients with severe cardiovascular disease
  • -Recent upper airway infection (within one month before the start of the study)
  • -Chronic rhino-sinusitis
  • -Use of systemic steroids 30 days before the start of the study
  • -Use of ß blocking agents
  • -Pregnancy and breast feeding during the study
  • -Addiction to alcohol or drugs that may interfere with the overall compliance
  • -Planned surgical interventions during the study period
  • -Concomitant treatment with anticholinergics, theophyllines and LTRA
  • -At visit 2: infections and unstable asthma (symptoms more than 1time a week, nocturnal symptoms, PEF variability of >20%) or upper respiratory tract infection during run-in

研究者

发起方
niversity Hospital Antwerp

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