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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00311506

Enrollment

Registered

2006-04-06

Start date

1999-10-31

Completion date

2004-06-30

Last updated

2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Pulmozyme

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

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

Outcome results