Sinus Disease and Smell in Young Children With Cystic Fibrosis
Observes sinus disease and smell in children with cystic fibrosis taking modulator drugs.
Plain-language title generated from the registry record
Registry title: Sinus Disease in Young Children With Cystic Fibrosis
Key facts
- Where
- Aurora, Charlottesville, Cincinnati, Colchester, Iowa City, and Kansas City, United StatesSee the 6 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children aged 2 to 8 with cystic fibrosis. One group is about to start modulator therapy; the other group is not taking it.
- Age
- 2 to 8 years old at the first study visit
- Sex
- All sexes
- Earlier treatment
- Children in the modulator group must not have used ivacaftor or elexacaftor/tezacaftor/ivacaftor in the 180 days before the first visit.
- Biomarker or test result
- Modulator group: a CFTR mutation that fits the approved use of ivacaftor or elexacaftor/tezacaftor/ivacaftor. Control group: a CFTR mutation that rules out this therapy, or a clinical decision not to start it.
Main reasons for not taking part
- Investigational drug in the 28 days before the first study visit
- Ivacaftor or elexacaftor/tezacaftor/ivacaftor in the 180 days before the first study visit
- Long-term oral corticosteroids in the 28 days before the first study visit
- Sinus surgery in the 180 days before the first study visit
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 8 years old?
Source: NCT06191640, who can take part
Where in United States
- Children's Hospital ColoradoAurora, United StatesTaking people
- University of VirginiaCharlottesville, United StatesTaking people
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesTaking people
- University of VermontColchester, United StatesTaking people
- University of IowaIowa City, United StatesTaking people
- University of Kansas Medical CenterKansas City, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of California, Los Angeles
- Trial code
- NCT06191640
- Record updated
- 10 September 2026
- Original 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.Read full original descriptionShow less
Sinus Disease in Young Children With Cystic Fibrosis
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.
Inclusion: 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.
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; For Both Groups:.