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临床试验/NCT00311506
NCT00311506已完成不适用

A Study to Determine the Variability of a 6-Minute Walk Test in Cystic Fibrosis Subjects With Advanced Lung Disease

Genentech, Inc.0 个研究点目标入组 25 人开始时间: 1999年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25

研究概览

简要总结

This is an observational study to be conducted at approximately 25 sites in the United States. Approximately 25 subjects with severe obstructive CF lung disease (FVC <40% predicted) will be enrolled.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to provide written informed consent
  • Males or females who will be >=14 years old at Visit 3
  • A proven diagnosis of CF as evidenced by a positive sweat test (sweat sodium or chloride >60 mEq/L by quantitative pilocarpine iontophoresis), or genotype and clinical symptoms consistent with the diagnosis of CF
  • Able to perform reproducible spirometry maneuvers at Visit 1 in accordance with the American Thoracic Society (coefficient of variation for three FEV1 maneuvers <=0.2)
  • FVC <40% predicted for height, age and sex at Visit 1
  • On a stable regimen of chest physiotherapy (CPT) begun at least 7 days prior to Visit 1
  • Able to complete the 6-minute walk test at Visit 1

排除标准

  • Use of an investigational drug or device within 28 days prior to Visit 1
  • Experiencing an episode of severe acute respiratory failure, as determined by the investigator

研究者

申办方类型
Industry

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