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

Completed

• Conditions: Cystic Fibrosis

• Registration Number: NCT00311506
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-10
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Study First Submitted: 2006-03-25
• Study First Submitted QC: 2006-04-04
• Study First Posted: 2006-04-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-12
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified