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
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
- 否
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
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