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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT02057458
Eligibility Criteria:
Inclusion Criteria.
* Diagnosis of CF and healthy controls
* Men and women (greater than 18 yrs. old)
* Resting oxygen saturation (room air) greater than 90%
* Forced expiratory volume (FEV1) percent predicted greater than 30%
* Patients with or without CF related diabetes
* Traditional CF-treatment medications
* Ability to perform reliable/reproducible pulmonary function tests (PFT)
* Clinically stable for 2 weeks (no exacerbations or need for antibiotic treatment within 2 weeks of testing or major change in medical status)
Exclusion Criteria.
* Children less than 17 years old
* Body mass less than 20 kg
* A diagnosis of pulmonary arterial hypertension (PAH)
* FEV1 less than 30% of predicted
* Resting oxygen saturation (SpO2) less than 90%
* Self-reported to be a smoker
* Current use of any vaso-active medications
* History of migraine headaches
* Pregnant or nursing at the time of the investigation
* A clinical diagnosis of cardiovascular disease, hypertension, or CF related diabetes
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02057458
Study Brief:
Protocol Section:
NCT02057458