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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT03485456
Eligibility Criteria:
Inclusion criteria:
* Clinical diagnosis of CF and a positive sweat test or two CF-related mutations;
* Age 6 - 18 years
* Ability to breathe through a mouthpiece and to use the Cyclops
* Ability to perform pulmonary function tests
* Written informed consent (child and parents)
Exclusion criteria:
* Acute exacerbation of pulmonary infection
* FEV1 \< 60%
* Subjects with known or suspected renal, auditory, vestibular of neuromuscular dysfunction, or with severe, active haemoptysis
* History of adverse events on previous tobramycin or other aminoglycoside use
* No concurrent use of cisplatin, cyclosporine, amphotericin B, cephalosporins, polymyxins, vancomycin and NSAID's
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT03485456
Study Brief:
Protocol Section:
NCT03485456