Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
NCT ID:
NCT00311506
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT00311506
Study Brief:
Protocol Section:
NCT00311506