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Non-HEMT/Control Group for Cystic Fibrosis

N/A
Recruiting
Led By Daniel M Beswick, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1-year, and 2-year follow-up
Awards & highlights

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.

Eligible Conditions
  • Cystic Fibrosis
  • Anomia
  • Olfactory Disorders
  • Chronic Sinusitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1-year, and 2-year follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1-year, and 2-year follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in MRI sinus opacification
Change in olfactory bulb volume
Secondary outcome measures
Change in Brief Questionnaire of Olfactory Disorders (BQOD) Scores
Change in Pediatric Smell Wheel (PSW) Scores
Change in Sinus and Nasal Quality of Life Survey (SN-5) - Overall Quality of Life (QOL) Domain
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Non-HEMT/Control GroupExperimental Treatment0 Interventions
Children with CF not on ivacaftor or elexacaftor/tezacaftor/ivacaftor CFTR modulator therapy.
Group II: HEMT GroupExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of VermontOTHER
267 Previous Clinical Trials
3,743,661 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
16 Patients Enrolled for Cystic Fibrosis
Children's Hospital Medical Center, CincinnatiOTHER
815 Previous Clinical Trials
6,531,511 Total Patients Enrolled
22 Trials studying Cystic Fibrosis
1,105 Patients Enrolled for Cystic Fibrosis
University of California, Los AngelesLead Sponsor
1,530 Previous Clinical Trials
10,278,122 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
170 Patients Enrolled for Cystic Fibrosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Sinus Disease in Young Children With Cystic Fibrosis
Daniel M. Beswick 2023. "Sinus Disease in Young Children With Cystic Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06191640.
All > Kansas City > Colorado Springs
~53 spots leftby Apr 2026
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