Sinus Disease in Young Children With Cystic Fibrosis

Description

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.

Conditions

Cystic Fibrosis in Children, Cystic Fibrosis, Chronic Rhinosinusitis (Diagnosis), Olfactory Disorder, Olfactory Impairment

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Study Overview

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Study Details

Study overview

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.

Sinus Disease in Young Children With Cystic Fibrosis

Sinus Disease in Young Children With Cystic Fibrosis

Condition
Cystic Fibrosis in Children
Intervention / Treatment

-

Contacts and Locations

Aurora

Children's Hospital Colorado, Aurora, Colorado, United States, 80045

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Kansas City

University of Kansas Medical Center, Kansas City, Kansas, United States, 66160

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229-3039

Colchester

University of Vermont, Colchester, Vermont, United States, 05446

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Children with documentation of a CF diagnosis
  • * Age 2-8 years old at first study visit
  • * CFTR mutation consistent with FDA labeled indication of highly effective modulator therapy (ivacaftor or elexacaftor/tezacaftor/ivacaftor)
  • * Clinician intent to prescribe ivacaftor or ETI so that enrollment is before start of HEMT
  • * Children with documentation of a CF diagnosis
  • * Age 2-8 years at first study visit
  • * Ineligible for highly effective modulator therapy (ivacaftor or elexacaftor/tezacaftor/ivacaftor) based on CFTR mutation or clinical decision not to initiate HEMT if eligible
  • * Use of an investigational drug within 28 days prior to the first study visit
  • * Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor within the 180 days prior to and including the first study visit
  • * Use of chronic oral corticosteroids within the 28 days prior to and including the first study visit.
  • * Sinus surgery within 180 days prior to the first study visit

Ages Eligible for Study

2 Years to 8 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Los Angeles,

Daniel M Beswick, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

2026-04