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Sinus Disease in Young Children With Cystic Fibrosis

NCT06191640 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-05-11

No results posted yet for this study

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 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

  • Cystic Fibrosis in Children
  • Cystic Fibrosis
  • Chronic Rhinosinusitis (Diagnosis)
  • Olfactory Disorder
  • Olfactory Impairment

Interventions

DRUG

Ivacaftor or elexacaftor/tezacaftor/ivacaftor

HEMT's are prescribed at the discretion of the treating physician and is not dictated by the principal investigator of this study.

Sponsors & Collaborators

  • University of Kansas Medical Center

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • University of Iowa

    collaborator OTHER

  • University of Virginia

    collaborator OTHER

  • University of Vermont

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Children's Hospital Colorado

    collaborator OTHER

  • University of California, Los Angeles

    lead OTHER

Principal Investigators

  • Daniel M Beswick, MD · University of California, Los Angeles

Eligibility

Min Age
2 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-12
Primary Completion
2029-06-30
Completion
2029-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06191640 on ClinicalTrials.gov