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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.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00311506
First received: March 25, 2006
Last updated: February 21, 2017
Last verified: February 2017
  Purpose
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.

Condition
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 1, 1999
Study Completion Date: June 10, 2004
Primary Completion Date: June 10, 2004 (Final data collection date for primary outcome measure)
  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311506

Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Morris Cheeks, M.D. Genentech, Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00311506     History of Changes
Other Study ID Numbers: Z1943n
Study First Received: March 25, 2006
Last Updated: February 21, 2017

Keywords provided by Genentech, Inc.:
Pulmozyme

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Lung Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on March 28, 2017