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 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT01973192
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of CF by newborn screening, at least one clinical feature of CF, and documented sweat chloride greater than 60 mEq/L by quantitative pilocarpine iontophoresis or compatible genotype with two identifiable mutant CFTR alleles.
2. Less than 4 months of age at Screening Visit
3. Ability to comply with study visits and study procedures as judged by site investigator.
Exclusion Criteria:
1. Intercurrent respiratory illness, defined as increase in cough, wheezing, or respiratory rate with onset 14 days before iPFT-bronchoscopy visit.
2. Measured hemoglobin oxygen saturation less than 95% during the iPFT-bronchoscopy visit.
3. History of adverse reaction to sedation.
4. Clinically significant upper airway obstruction as determined by the site investigator.
5. Severe gastroesophageal reflux, defined as persistent frequent emesis despite therapy.
6. Major organ dysfunction, not including pancreatic dysfunction.
7. Physical findings that would compromise the safety of the subject or the quality of the study data as determined by site investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
4 Months
Study:
NCT01973192
Study Brief:
Protocol Section:
NCT01973192