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临床试验/EUCTR2008-000562-23-DE
EUCTR2008-000562-23-DE进行中(未招募)不适用

Randomised, Double-Blind, Cross-over Study to Assess the Efficacyand Safety of 4 Weeks of Once Daily Treatment of 2 Doses of OrallyInhaled BI 1744 CL, each in fixed dose combination (FDC) with 5µgTiotropium Bromide (Delivered by the Respimat® Inhaler) in Patientswith COPD - Efficacy and Safety of 4 Weeks QD orally inhaled FDC BI 1744/tiotropium via RESPIMAT in COPD

Boehringer Ingelheim Pharma GmbH & Co.KG0 个研究点目标入组 96 人开始时间: 2008年5月6日最近更新:
适应症
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
96

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

  • Signed informed consent, diagnosis of COPD, post-bronchodilator FEV1 of more or equal 30% of predicted normal and less than 80% of predicted normal, 40 years of age or older, current or ex-smokers with a smoking history of more than 10 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) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Significant disease other than COPD, abnormal baseline laboratory, history of asthma or total blood eosinophil count of equal or more than 600 per mm3, history of myocardial infarction/life-threatening pulmonary obstruction/cystic fibrosis/bronchiectasis/alcohol or drug abuse, treatment with medications which prolong the QT/QTc interval, treatment with oral ß-adrenergics/ß-blockers/oral corticosteroids at unstable doses or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day, use of daytime oxygen for more than one hour per day, currently undergoing rehabilitation (or within prior 6 weeks), other investigational drug, known hypersensitivity to ß-adrenergics or anticholinergics or other components of the drug product

研究者

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