Status:
COMPLETED
A Study to Determine the Variability of a 6-Minute Walk Test in Cystic Fibrosis Subjects With Advanced Lung Disease
Lead Sponsor:
Genentech, Inc.
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
14+ years
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 1999
Trial Type :
OBSERVATIONAL
End Date :
June 1 2004
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00311506
Start Date
October 1 1999
End Date
June 1 2004
Last Update
May 16 2017
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