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
Verified date | May 2017 |
Source | Genentech, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Genentech, Inc. |
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