NCT06191640Recruiting
Sinus Disease in Young Children With Cystic Fibrosis
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 19 Dec 2023
- Start date
- 12 Apr 2023
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- University of California, Los Angeles
- Diseases
- Cystic fibrosis
- NCT number
- NCT06191640
What you commit to
- Study type: Observational
- Planned participants: 80
- From 12 Apr 2023 to the primary completion date, 30 Jun 2029
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- For Both Groups:
Who the study is looking for
- 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
Age in the registry: 2 years to 8 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| University of Vermont Coordinator of this site? Confirm its status | Colchester | United States | Recruiting |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.