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 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 12:46 AM
NCT ID:
NCT02378467
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of CF as evidenced by one or more clinical feature consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria:
* A documented sweat chloride ≥ 60 milliequivalents of solute per litre (mEq/L) by quantitative pilocarpine iontophoresis (QPIT)
* A documented genotype with two disease-causing mutations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene
* Informed consent by parent or legal guardian
* Age ≥ 36 months and ≤72 months at Screening visit
* Ability to comply with medication use, study visits and study procedures as judged by the site investigator
* Ability to perform technically acceptable MBW measurements at the screening and enrollment visits
Exclusion Criteria:
* Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset within 3 weeks preceding Screening or Enrollment visit
* Acute wheezing at Screening or Enrollment visit
* Oxygen saturation \< 95% (\<90% in centers located above 4000 feet elevation) at Screening or Enrollment visit
* Physical findings that would compromise the safety of the participant or the quality of the study data as determined by site investigator
* Investigational drug use within 30 days prior to Screening or Enrollment visit
* Treatment with inhaled hypertonic saline at any concentration within 30 days prior to Screening or Enrollment visit
* Chronic lung disease not related to CF
* Inability to tolerate first dose of study treatment at the Enrollment visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
5 Years
Study:
NCT02378467
Study Brief:
Protocol Section:
NCT02378467