RecruitingNCT06191640

Sinus Disease in Young Children With Cystic Fibrosis


Sponsor

University of California, Los Angeles

Enrollment

80 participants

Start Date

Apr 12, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 2 YearsMax Age: 8 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ivacaftor or elexacaftor/tezacaftor/ivacaftor for people with chronic rhinosinusitis (diagnosis), cystic fibrosis, and other related conditions. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 2 Years to 8 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIvacaftor 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

View Full Details on ClinicalTrials.gov

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NCT06191640


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