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临床试验/EUCTR2006-003385-34-NL
EUCTR2006-003385-34-NL进行中(未招募)不适用

The effect of tiotropium-bromide on deep inspiration-induced bronchodilation and airway responsiveness in asthma. - Tiotropium-bromide and lung mechanics

Boehringer Ingelheim Pharma GmbH & Co. KG0 个研究点目标入组 24 人开始时间: 2006年9月28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)
入组人数
24

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

  • History of episodic symptoms or wheezing, breathlessness, cough or chest tightness (> 12 months)
  • FEV1 > 70% of predicted
  • Hyperresponsive in standard histamine challenge (PC20histamine < 8 mg/ml)
  • Atopic, as reflected by one or more wheal (> 3 mm) and flare responses to skin prick test (SPT) with 10 common airborne allergen extracts (Abelló, ALK Benelux)
  • Non smoking or ex-smoking (for at least 12 months, < 5 pack years)
  • 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

  • No usage inhaled corticosteroids for 4 weeks or oral corticosteroids for 3 months prior to and during the study.
  • No usage of long acting beta2-agonists 24 hours prior to a test and during the study.
  • No usage of inhaled or oral medication such as antihistamines, ketotifen, sodium chromoglycate, nedocromil sodium, leukotriene receptor antagonists, theophylline, and NSAID's for at least 2 weeks prior to and during the study.
  • Prohibition of use of short acting beta2-agonists or ipatropium bromide 8 hours prior to a test.
  • No history of respiratory tract infection, or relevant allergen exposure during 2 weeks prior to the study.
  • No known other pulmonary abnormalities or cardiovascular diseases.
  • No acute illness.

研究者

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