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
ClinicalTrials.gov Identifier:
NCT00311506
First received: March 25, 2006
Last updated: April 4, 2006
Last verified: April 2006
  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 Phase
Cystic Fibrosis
Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
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:

Estimated Enrollment: 25
  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311506

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00311506     History of Changes
Other Study ID Numbers: Z1943n
Study First Received: March 25, 2006
Last Updated: April 4, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Genentech:
Pulmozyme

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

ClinicalTrials.gov processed this record on April 17, 2014