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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT01772758
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of CF and healthy controls
* Men and women (\> 18 yrs. old)
* Boys and girls (7 -17 yrs. old)
* FEV1 percent predicted \> 30%
* Resting oxygen saturation (room air) \>90%
* Patients with or without CFRD
* Traditional CF-treatment medications
* Ability to perform reliable/reproducible PFTs
* 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 6 yrs. old and younger
* FEV1 percent predicted \< 30%
* Resting oxygen saturation (room air) \< 90%
* 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.)
* Inability to swallow pills
* Patients with B. Cepacia (only \~3% of our CF center patient population)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Study:
NCT01772758
Study Brief:
Protocol Section:
NCT01772758