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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT02778750
Eligibility Criteria:
Inclusion Criteria:
* CF diagnosis
* able to produce sputum
* no recent (one month) exacerbation defined as physician treatment with antibiotics for ≥ 7days
* FEV1 ≥ 30% of predicted.
Exclusion Criteria:
* Initiation of any new chronic therapy (e.g., ibuprofen, aerosolized rhDNase, hypertonic saline, azithromycin, tobramycin inhalation solution, aztreonam inhalation solution, ivacaftor) within 8 weeks prior to enrolment
* introduction of vitamins or proton pump inhibitors within 8 weeks prior to enrolment
* use of new investigational therapy within 4 weeks
* current smoker; use of oral corticosteroids
* Initiation of treatment or change in regimen for allergic bronchopulmonary aspergillosis or nontuberculous mycobacteria within 8 weeks.
* liver enzymes \> 3 times the upper limit
* pregnancy
Additional Exclusion Criteria for Bronchoscopy Subgroup (Aims 2 and 3):
* FEV1 \< 50% of predicted.
* Significant cardiovascular disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure.
* Significant renal disease (Creatinine Clearance \< 30%).
* Severe malnutrition (BMI \<18kg/m2)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02778750
Study Brief:
Protocol Section:
NCT02778750