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 @ 2:58 AM
Ignite Modification Date:
2025-12-25 @ 2:58 AM
NCT ID:
NCT00004533
Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Diagnosis of cystic fibrosis (CF) with mild to moderate lung disease; FVC at least 60% predicted; Schwachman-Kulczycki score at least 65; Sweat chloride greater than 60 mEq/L
All CF genotypes allowed
No sputum colonization with Burkholderia cepacia or another multiply resistant organism
No recurrent or intermittent hemoptysis; At least 1 year since significant hemoptysis requiring transfusion or embolization OR Coughing of greater than 30 mL of blood more often than once a week
--Prior/Concurrent Therapy--
At least 30 days since hospitalization or home intravenous antibiotic therapy for pulmonary exacerbation
No concurrent investigational drugs or therapy
--Patient Characteristics--
Other: No concurrent cigarette smoking; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT00004533
Study Brief:
Protocol Section:
NCT00004533