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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311506
• Other study ID #: Z1943n
• Status: Completed
• Phase: N/A
• First received: March 25, 2006
• Last updated: May 12, 2017
• Start date: October 1999
• Est. completion date: June 2004

Study information

• Verified date: May 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Lung Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.