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Sinus Disease in Young Children With Cystic Fibrosis Study

This study is looking at how highly effective cystic fibrosis (CF) medicines, like ivacaftor or elexacaftor/tezacaftor/ivacaftor, affect sinus problems and sense of smell in young children with CF. It includes children aged 2 to 8 years old. Some children will be taking these CF medicines, and others will not, acting as a comparison group. Researchers will use MRI scans of the sinuses and brain, as well as smell tests and surveys, to see if these medicines improve sinus health and sense of smell over two years. The study aims to understand if starting these medicines early can help with these issues. The study plans to enroll 80 children, but its current status is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information without giving specific treatments. It involves two groups of children and plans to enroll 80 participants.
What's involved
You would have assessments at the start, after one year, and after two years. These assessments include MRI scans, olfactory (smell) tests, and quality of life surveys.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two years after their initial assessment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06191640

Sinus Disease in Young Children With Cystic Fibrosis

Recruiting
Not specifiedAges 2–8Observational
University of California, Los Angeles
~80 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:Ivacaftor or elexacaftor/tezacaftor/ivacaftor

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in MRI sinus opacification
Measured over Baseline, 1-year, and 2-year follow-up
+1 more outcome measured

Conditions

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

Explore related trials

Chronic SinusitisCystic FibrosisOlfactory DysfunctionCFTR Gene

Where it's being run

6 sites across 6 states
Colorado1
Iowa1
Kansas1
Ohio1
Vermont1
Virginia1

Study leadership

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

Who to contact

Daniel M Beswick, MD
[email protected]
310-206-8457
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Change in MRI sinus opacificationBaseline, 1-year, and 2-year follow-up

    Measurement involves calculating percent total sinus opacification (%) using MRI, where sinus contents are differentiated into air and soft tissue/fluid.

  • Change in olfactory bulb volumeBaseline, 1-year, and 2-year follow-up

    Assessment includes segmenting the olfactory bulb on consecutive coronal slices using MRI, then combining these into a 3-dimensional region. The volume of this region is then calculated in cubic millimeters (mm3).