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RECRUITING
NCT06191640

Sinus Disease in Young Children With Cystic Fibrosis

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

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

Interventions

DRUG

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