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临床试验/ISRCTN90761040
ISRCTN90761040已完成不适用

The protective effect of a nasal corticosteroid (Avamys®) on exercise induced airway obstruction in cold air in children: a randomised double-blind placebo-controlled single-centre trial

Paediatric Research Foundation Enschede, Medical Centre Twente (Netherlands)0 个研究点目标入组 91 人开始时间: 2009年7月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
91

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Both males and females, aged between 12 and 17 years
  • 2. Clinical history of allergic rhinitis and/or allergic asthma
  • 3. Ability to perform reproducible lung function tests, i.e. coefficient of the predicted value variation in three of five consecutive measurements less than 5%
  • 4. Maximal FEV1 greater than 70% of predicted value
  • 5. Clinically stable period at least three weeks before the study period

排除标准

  • 1. Use of intranasal or systemic corticosteroids in the last four weeks prior to the study
  • 2. Use of antihistamines, cromoglycates, anticholinergics in two weeks prior to the study
  • 3. Use of long acting bronchodilators 24 hours before testing
  • 4. Use of short acting bronchodilators eight hours before testing
  • 5. Use of systemic corticosteroids, antihistamines, cromoglycates, anticholinergics, during the study
  • 6. Other pulmonary or cardiac disorder
  • 7. Deviation of the FEV1 of more than 12% from baseline spirometry and the FEV1 before subsequent exercise provocation challenges
  • 8. Signs of gastro-oesophageal reflux

研究者

发起方
Paediatric Research Foundation Enschede, Medical Centre Twente (Netherlands)

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