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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT05161858
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of PCD
1. Clinical features consistent with PCD PLUS
2. At least 1 diagnostic test consistent with PCD:
i) Biallelic pathogenic variants in PCD-associated genes identified by genetic panel testing including deletion/duplication analysis; ii) Ciliary ultrastructural defect by transmission electron microscopy known to be disease-causing, including outer dynein arm defects, outer dynein arm plus inner dynein arm (IDA) defects, IDA defects with microtubular disorganization and absent central pair
* Age ≥ 6 years
* At least one course of antibiotics (oral or IV) in the prior year prescribed to treat new or increased respiratory symptoms
* Smart phone and/or internet access available in home
* Informed consent provided by participant or parent/guardian, with assent provided as applicable
Exclusion Criteria:
* Acute course of antibiotics for respiratory symptoms completed \<14 days prior to enrollment or Visit 1 (evaluated at enrollment and Visit 1; visit may be rescheduled \>14 days after completion of antibiotics)
* Developmental or cognitive disability that would impair ability to complete PRO instruments or perform spirometry
* Congenital heart disease OTHER THAN repaired or resolved atrial septal defect (ASD) or ventricular septal defect (VSD)
* Asplenia or functional asplenia
* Co-existing non-pulmonary disease that, in the opinion of the investigator, could have significant impact on lung function or health-related quality of life (e.g., severe scoliosis) or overall health status (e.g., cancer, severe renal disease)
* Listed for or post-lung transplantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT05161858
Study Brief:
Protocol Section:
NCT05161858