跳至主要内容
临床试验/EUCTR2004-002440-96-GB
EUCTR2004-002440-96-GB进行中(未招募)不适用

A randomised placebo controlled trial of itraconazole in the treatment of fungal-sensitised patients with severe asthma and without ABPA. - FAST

South Manchester University Hospitals NHS Trust0 个研究点目标入组 104 人开始时间: 2005年6月29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
104

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 requiring
  • high dose inhaled steroids of >1000ug of beclomethasone or >500ug fluticasone or equivalent or continous steroids (>5mg prednisolone or equivalent for > 6 months or at least 4 courses over previous 12 months or 6 courses over previous 24 months and
  • Skin test reactivity to at least one fungal preparation significantly greater than control or a positive RAST test to at least 1 fungal antigen
  • 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

  • ABPA (any of the following exclude the patient:IgE > 1000, Aspergillus precipitins positive, Aspergillus specific IgG positive, fleeting pulmonary shadows.
  • Recurrent bacterial chest infecitons
  • Allergy to azoles
  • Pregnancy ( all potentially fertile women to use contraception)
  • Current treamtent with drugs that potentially interact with itraconazole and which cannot be stopped.
  • Significant cardiac disease
  • Significant immunosuppression
  • Abnormal liver function
  • Prior treatment with itraconazole in previous 8 months for > 2 days.
  • Current URTI in last 4 weeks.

研究者

发起方
South Manchester University Hospitals NHS Trust

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