Sinus Disease in Young Children With Cystic Fibrosis
Recruiting now
Conditions studied: Cystic Fibrosis in Children, Cystic Fibrosis, Chronic Rhinosinusitis (Diagnosis), Olfactory Disorder, Olfactory Impairment
In brief
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 facts
- Study ID
- NCT06191640
- Run by
- University of California, Los Angeles
- People needed
- 80
- Starts
- 2023-04-12
- Expected to finish
- 2029-06-30
- Last updated by the study team
- 2026-05-11
Who can join
Age: 2 and older, up to 8. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- HEMT Group:
- 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
- Non-HEMT/Control Group:
- 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
You may not qualify if…
- For Both Groups:
- 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
Where it is running
- Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
- University of Iowa — Iowa City, Iowa, United States (enrolling)
- University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
- University of Vermont — Colchester, Vermont, United States (enrolling)
- University of Virginia — Charlottesville, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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