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 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT01104402
Eligibility Criteria:
Inclusion Criteria:
* CF diagnosis confirmed with sweat test, abnormal nasal potential difference and/or genetic testing
* Age 14 and older
* Able to perform spirometry
* Clinically stable without antibiotic treatment for a pulmonary exacerbation in the two weeks prior to the screening visit
* Forced expiratory volume in the first second (FEV1) greater than 25% of predicted at screening
Exclusion Criteria:
* History of solid organ transplant
* Participation in any interventional trial within the last 30 days
* Inability to speak and read the English language well enough to complete questionnaires
* Colonization with Burkholderia cepacia genomovar III within the last 24 months
* Currently receiving antimicrobial treatment specifically used to treat active non-tuberculosis mycobacterium
* Confirmed diagnosis of allergic bronchopulmonary aspergillosis (ABPA) as defined by the Cystic Fibrosis Foundation (CFF) guidance document that is being actively treated
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT01104402
Study Brief:
Protocol Section:
NCT01104402