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:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-24 @ 1:35 PM
NCT ID:
NCT03338595
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with Cystic Fibrosis (homozygous deltaF508del)
* Prescribed Orkambi
* Men and women (\> 18 yrs. old)
* Boys and girls (7 -17 yrs. old)
* FEV1 percent predicted \> 40%
* Resting oxygen saturation (room air) \>85%
* Patients with or without CFRD
* Traditional CF-treatment medications
* Clinically stable for past 28 days (no exacerbations or change in medical status)
* Healthy Controls
Exclusion Criteria:
* Children 6 yrs. old and younger
* FEV1 percent predicted \< 40%
* Resting oxygen saturation (room air) \< 85%
* Clinical diagnosis of heart disease
* Pulmonary artery hypertension
* Febrile illness within two weeks of visit
* Current smokers
* Currently pregnant or nursing
* Individuals on vaso-active medications (i.e. nitrates, beta blockers, ACE inhibitors, etc.)
* Use of VX-770 within 6 months prior to Visit 1
* History of solid organ transplantation
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Study:
NCT03338595
Study Brief:
Protocol Section:
NCT03338595