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 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT00928135
Eligibility Criteria:
Inclusion Criteria:
* Subjects with CF (medical record evidence of CFTR(Cystic fibrosis transmembrane conductance regulator) mutation or sweat chloride test or nasal voltage difference, and 1 or more clinical findings of CF),
* Age 12 or greater
* FEV1 \> 30% predicted(within the last 14 days and oxygen saturation \> 90% on FiO2(fraction of inspired oxygen) ≤ 50%,
* Admitted for an exacerbation,
* Use of effective contraception in women,
* Able to provide written informed consent.
Exclusion Criteria:
* Pregnancy,
* History of asthma based on methacholine challenge or bronchial hyperresponsiveness on PFTS(Pulmonary Function Test),
* Hemoptysis more than 60 mL within the last 30 days,
* Use of any investigational study drug within the last 30 days,
* Initiation of hypertonic saline within the last 30 days,
* A serum creatinine 2 mg/dl or more
* Active malignancy in the last year
* Antibiotics for CF exacerbation as an outpatient in the last 2 weeks
* B cepacia colonization
* Waiting list for lung transplant
* Lack of FEV1 data from the last 14 days
* Previous participation in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00928135
Study Brief:
Protocol Section:
NCT00928135