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临床试验/NCT00379730
NCT00379730已完成1 期

A Randomized, Double-blind Study of Treatment With a Known Anti-inflammatory (Prednisolone) to Evaluate Novel Endpoints in Patients With Chronic Obstructive Pulmonary Disease (COPD)

GlaxoSmithKline6 个研究点 分布在 4 个国家目标入组 90 人开始时间: 2006年3月21日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
90
试验地点
6
主要终点
lung function tests using a system called Impulse oscillometry (IOS). CT scans to measure the thickness of the tubes in the lungs Blood, sputum and breath samples to measure chemical products in the lungs and body that relate to COPD

研究概览

简要总结

Prednisolone will be used as a model medication to identify new clinical outcomes for future evaluation of new therapies in short-term studies (up to 4 weeks) in patients with Chronic Obstructive Pulmonary Disease (COPD).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • An established clinical history of COPD
  • Evidence of bronchitis
  • Current or ex-smoker

排除标准

  • COPD exacerbation requiring steroid and/or antibiotics in the last month
  • Taking oral or inhaled steroids for more than 14 days in the last 6 months
  • Unable to withhold salbutamol/albuterol for a 6 hour period
  • History of alcohol, substance or drug abuse within the last year.
  • Other significant medical condition e.g. diabetes
  • Cancer that has not been in complete remission for at least 5 years
  • As a result of the medical interview, physical examination or screening investigations, that the doctor considers the subject unfit for the study.

结局指标

主要结局

lung function tests using a system called Impulse oscillometry (IOS). CT scans to measure the thickness of the tubes in the lungs Blood, sputum and breath samples to measure chemical products in the lungs and body that relate to COPD

次要结局

  • Traditional lung function tests & Symptom Questionnaires

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (6)

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