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NCT06191640 · ClinicalTrials.gov registry record
Sinus Disease in Young Children With Cystic Fibrosis
A clinical trial of Cystic Fibrosis and Chronic Rhinosinusitis (Diagnosis), sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- 80
- Enrollment target
- 6
- Study locations
NCT06191640: Recruiting study of Cystic Fibrosis and Chronic Rhinosinusitis (Diagnosis), sponsored by University of California, Los Angeles.
NCT06191640 is a study of Cystic Fibrosis and Chronic Rhinosinusitis (Diagnosis) that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 80 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (55% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06191640, a study of Cystic Fibrosis and Chronic Rhinosinusitis (Diagnosis), is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- 80 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
Measurement involves calculating percent total sinus opacification (%) using MRI, where sinus contents are differentiated into air and soft tissue/fluid.
Conditions Studied
Interventions
- DRUG Ivacaftor or elexacaftor/tezacaftor/ivacaftor
Study Locations (6)
Colorado
- Children's Hospital Colorado - Aurora
Iowa
- University of Iowa - Iowa City
Kansas
- University of Kansas Medical Center - Kansas City
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Vermont
- University of Vermont - Colchester
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2023-04-12 |
| Est. Completion | 2026-04 |
What NCT06191640 shows while recruiting
NCT06191640 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (55% lower).
The record links to 5 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which Ivacaftor or elexacaftor/tezacaftor/ivacaftor is the first listed.
NCT06191640 lists 6 locations in 6 states (Colorado, Iowa, Kansas).
Frequently Asked Questions
What is clinical trial NCT06191640 about?
NCT06191640 is a clinical study titled "Sinus Disease in Young Children With Cystic Fibrosis". 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: chi...
What is the current status of trial NCT06191640?
This trial is currently recruiting. The enrollment target is 80 participants. The study started on 2023-04-12. Estimated completion is 2026-04.
What conditions does trial NCT06191640 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Chronic Rhinosinusitis (Diagnosis), Cystic Fibrosis in Children, Olfactory Disorder, Olfactory Impairment.
What interventions are being tested in trial NCT06191640?
The interventions under investigation include: Ivacaftor or elexacaftor/tezacaftor/ivacaftor (DRUG).
Who is sponsoring clinical trial NCT06191640?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06191640 being conducted?
This trial has 6 study locations across Colorado, Iowa, Kansas, Ohio, Vermont. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06191640's enrollment target sits among peer trials
80 71st of 169 higher than 98 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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