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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT06238856
Eligibility Criteria:
Inclusion Criteria:
* Study participants must produce sputum that is positive for Pseudomonas aeruginosa.
* Confirmed diagnosis of CF (positive sweat chloride \>60 milliequivalents (mEq)/liter (by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF accompanied by one or more clinical features with the CF phenotype.
* Forced expiratory volume (FEV1) ≥40% predicted at Screening as calculated by the Knudsen reference equations.
* Clinically stable with no evidence of current pulmonary exacerbation.
Exclusion Criteria:
* History of lung transplantation.
* Use of intravenous antibiotics or oral quinolones within 14 days of Screening.
* Use of low dose oral antibiotics (e.g. tetracycline, sulfa) for acne or other conditions within 30 days of Screening.
* Use of systemic corticosteroids (≥20 milligrams \[mg\] of prednisone per day) within 30 days of Screening.
* Initiation of TOBI® (tobramycin), high dose ibuprofen, recombinant human DNase (rhDNase), or macrolide antibiotics within 60 days of Screening.
* History of sputum or throat swab culture yielding Burkholderia cepacia complex within 2 years of Screening or growth of Burkholderia cepacia complex from the sputum or throat swab culture obtained at Screening.
* History of biliary cirrhosis, portal hypertension, or splenomegaly or splenomegaly on physical exam at Screening or enrollment.
* History of daily continuous oxygen supplementation or requirement for more than 2 liter per minute (L/min) at night.
Note: Other inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06238856
Study Brief:
Protocol Section:
NCT06238856