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

This study has been completed.
Information provided by:
Genentech, Inc. Identifier:
First received: March 25, 2006
Last updated: May 12, 2017
Last verified: May 2017
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.

Cystic Fibrosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Study to Determine the Variability of a 6-Minute Walk Test in Cystic Fibrosis Subjects With Advanced Lung Disease

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Estimated Enrollment: 25
Actual Study Start Date: October 1999
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00311506

Sponsors and Collaborators
Genentech, Inc.
Study Director: Morris Cheeks, M.D. Genentech, Inc.
  More Information Identifier: NCT00311506     History of Changes
Other Study ID Numbers: Z1943n
Study First Received: March 25, 2006
Last Updated: May 12, 2017

Keywords provided by Genentech, Inc.:

Additional relevant MeSH terms:
Cystic Fibrosis
Lung Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases processed this record on May 25, 2017