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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT03445793
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of CF
* Male or female subjects greater than or equal to 12 years of age
* Ability to reproducibly perform spirometry testing
* Physician decision to treat with tezacaftor/ivacaftor (Smydeko)
* Ability to understand and sign a written informed consent or assent and comply with the requirements of the study
* Continuous use of orkambi for at least 1 month prior to visit 1
Exclusion Criteria:
* History of hypersensitivity to tezacaftor and/or ivacaftor
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
* Any acute lower respiratory symptoms treated with oral, inhaled or intravenous antibiotics (IV) or systemic corticosteroids within the 2 weeks prior to Visit 1
* Major or traumatic surgery within 12 weeks prior to Visit 1
* For women of child-bearing potential: a positive pregnancy test at Visit 1
* Unable or unwilling to fast (including no enteric tube feedings) for at least 6 hours prior each visit
* Initiation of any new chronic therapy within 4 weeks prior to Visit 1
* Use of an investigational agent within 28 days prior to Visit 1
* Use of chronic oral corticosteroids within 28 days prior to Visit 1
* Treatment for nontuberculous mycobacterial (NTM) infection, consisting of greater than or equal to two antibiotics (oral, IV, and/or inhaled) within 28 days prior to Visit 1
* History of lung or liver transplantation, or listing for organ transplantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT03445793
Study Brief:
Protocol Section:
NCT03445793