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

NCT ID: NCT00311506

Last Updated: 2017-05-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1999-10-31
• Study Completion Date: 2004-06-30

Brief 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.

Conditions

Cystic Fibrosis

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Morris Cheeks, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Other Identifiers

Z1943n

Identifier Type: -

Identifier Source: org_study_id