Sinus Disease in Young Children With Cystic Fibrosis

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of California, Los Angeles
Study ID
NCT06191640
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
2 Years - 8 Years
Healthy Volunteers
Not accepted

Interventions

  • Ivacaftor or elexacaftor/tezacaftor/ivacaftor — DRUG
    HEMT's are prescribed at the discretion of the treating physician and is not dictated by the principal investigator of this study.

Study Details

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.

Key Dates

Start date
Apr 12, 2023
Status verified
Aug 2025
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: HEMT Group
    Children with CF planning to start ivacaftor or elexacaftor/tezacaftor/ivacaftor CFTR modulator therapy. Participants from the non-HEMT group of this study may enroll into the HEMT cohort if they become eligible for these CFTR modulator therapies and plan to start them.
  • Arm: Non-HEMT/Control Group
    Children with CF not on ivacaftor or elexacaftor/tezacaftor/ivacaftor CFTR modulator therapy.

Primary Outcome Measure

Change in MRI sinus opacification [ Time Frame: Baseline, 1-year, and 2-year follow-up ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Edith Zemanick, MD
Mary Cross
University of IowaIowa CityIowa52242
Sean B Fain, PhD
Mary Teresi
University of Kansas Medical CenterKansas CityKansas66160
Michael Lewis, MD
Larry Scott
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-3039
Jason Woods, PhD
Priyanka Desirazu
University of VermontColchesterVermont05446
Jillian S Sullivan, MD
Julie Sweet
University of VirginiaCharlottesvilleVirginia22903
Jaime Mata, MS, PhD
Roselove N Nunoo-Asare

Find similar trials in Aurora, CO

By research site
Children's Hospital Colorado· Aurora, COUniversity of Iowa· Iowa City, IAUniversity of Kansas Medical Center· Kansas City, KSCincinnati Children's Hospital Medical Center· Cincinnati, OHUniversity of Vermont· Colchester, VTUniversity of Virginia· Charlottesville, VA

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