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:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT00840333
Eligibility Criteria:
Inclusion Criteria (selected):
* 6 to 16 years of age (inclusive) at Visit 1
* Weight is greater than or equal to 14 kilograms (kg)
* Confirmed Diagnosis of Cystic Fibrosis
* Patients are able to elicit an FEV1 \>/= 25% of predicted value (Wang criteria)
* Clinically stable with no changes in health status within the last 14 days
* Able to reproducibly undergo spirometry testing
Exclusion Criteria (selected):
* Use of any nebulized or systemic antibiotics within 7 days prior to baseline
* History of intolerance or hypersensitivity to fluoroquinolones or intolerance with aerosol medications including bronchodilators
* CrCl \< 50mL/min/1.73m2, AST, ALT or total bilirubin \>/= 3 x ULN at Screening or evidence of severe liver disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
16 Years
Study:
NCT00840333
Study Brief:
Protocol Section:
NCT00840333