Actively Recruiting
Sinus Disease in Young Children With Cystic Fibrosis
Led by University of California, Los Angeles · Updated on 2026-05-11
80
Participants Needed
6
Research Sites
324 weeks
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
U
University of Kansas Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Sinus Disease in Young Children With Cystic Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children with confirmed cystic fibrosis diagnosis
- Age 2 to 8 years at first study visit
- For HEMT group: CFTR mutation eligible for ivacaftor or elexacaftor/tezacaftor/ivacaftor and planned prescription before starting treatment
- For control group: Ineligible for HEMT due to CFTR mutation or clinical decision not to start HEMT
You will not qualify if you...
- Use of an investigational drug within 28 days before first study visit
- Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor within 180 days before and including first study visit
- Use of chronic oral corticosteroids within 28 days before and including first study visit
- Sinus surgery within 180 days before first study visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
3
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Actively Recruiting
5
University of Vermont
Colchester, Vermont, United States, 05446
Actively Recruiting
6
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
D
Daniel M Beswick, MD
CONTACT
M
Marlene Florian
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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