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.

First Received: March 25, 2006 Last Updated: April 4, 2006 History of Changes

Sponsored by:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00311506

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 IV

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:	A Study to Determine the Variability of a 6-Minute Walk Test in Cystic Fibrosis Subjects With Advanced Lung Disease

Further study details as provided by Genentech:

Estimated Enrollment:

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:

Study Results This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Genentech:

Pulmozyme

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis

Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases

Additional relevant MeSH terms:

Pathologic Processes
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis

Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009