Status:
RECRUITING
Sinus Disease in Young Children With Cystic Fibrosis
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
University of Kansas Medical Center
Children's Hospital Medical Center, Cincinnati
Conditions:
Cystic Fibrosis in Children
Cystic Fibrosis
Eligibility:
All Genders
2-8 years
Brief Summary
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 ...
Detailed Description
This multi-center, prospective, observational study investigates the effects of highly effective modulator therapy (HEMT) on chronic rhinosinusitis (CRS) and olfactory dysfunction (OD) in young childr...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
April 12 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06191640
Start Date
April 12 2023
End Date
April 1 2026
Last Update
September 30 2025
Active Locations (6)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
University of Iowa
Iowa City, Iowa, United States, 52242
3
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039