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Sinus Disease in Young Children With Cystic Fibrosis
Sponsor: University of California, Los Angeles
Summary
This is a prospective, observational study examining the impact of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators on chronic rhinosinusitis (CRS) and olfactory dysfunction (OD) in young children with cystic fibrosis (YCwCF). This study involves two groups: children 2-8 years old, inclusive at initial visit, receiving highly effective modulator therapy (HEMT), and a control group of children 2-8 years old, inclusive at initial visit, not receiving HEMT. Outcomes will include sinus magnetic resonance imaging (MRI) scans, olfactory tests, and quality of life surveys obtained over a two-year period.
Key Details
Gender
All
Age Range
2 Years - 8 Years
Study Type
OBSERVATIONAL
Enrollment
80
Start Date
2023-04-12
Completion Date
2026-04
Last Updated
2025-09-30
Healthy Volunteers
No
Conditions
Interventions
Ivacaftor or elexacaftor/tezacaftor/ivacaftor
HEMT's are prescribed at the discretion of the treating physician and is not dictated by the principal investigator of this study.
Locations (6)
Children's Hospital Colorado
Aurora, Colorado, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
University of Vermont
Colchester, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States