Olfaction, Eating Preference, and Quality of Life in Cystic Fibrosis Chronic Rhinosinusitis.
Christine M Liu, Jakob L Fischer, Michelle J Lee...
https://pubmed.ncbi.nlm.nih.gov/40156369Actively Recruiting
Age: 18Years - 99Years
All Genders
ID04469439
The Impact of Sinus Surgery in the Era of Highly Effective Modulatory Therapy for Cystic Fibrosis and Chronic Rhinosinusitis
Led by University of California, Los Angeles · Updated on 2026-04-22
170
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
C
Cystic Fibrosis Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are examining the effects of endoscopic sinus surgery on individuals with cystic fibrosis who also have chronic rhinosinusitis (CRS). This observational study compares patients who undergo sinus surgery to those who receive only medical treatment for CRS. The study aims to understand how surgery impacts pulmonary health, quality of life, and other related outcomes in this population. Participants will be grouped into those who have endoscopic sinus surgery and those who continue with medical therapy without surgery. The study follows patients over time, capturing changes from baseline through 3, 6, 9, and 12 months. Both groups are observed to provide a comparison of pulmonary function, hospitalizations, quality of life, and sense of smell. During the study, participants will undergo evaluations at multiple time points including baseline, 3, 6, 9, and 12 months. These assessments include pulmonary function tests, tracking hospital days, quality of life questionnaires, and olfaction measurements. The research team will monitor these outcomes to understand the longer-term effects of sinus surgery versus medical management in cystic fibrosis patients, with total participation lasting up to one year.
CONDITIONS
Brief Title
Impact of Sinus Surgery on Individuals With Cystic Fibrosis
Who Can Participate
Age: 18Years - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 99 years inclusive
- Diagnosed with cystic fibrosis confirmed by genetic testing combined with clinical assessment and/or sweat chloride
- Diagnosed with chronic rhinosinusitis according to multidisciplinary sinusitis guidelines
- Chronic rhinosinusitis symptoms persisting after initial medical treatment
- Counseled about endoscopic sinus surgery and ongoing medical therapy with patient electing preferred treatment
You will not qualify if you...
- Endoscopic sinus surgery performed within the past 12 months
- Plans to receive follow-up care at non-participating institutions
- Unable to complete follow-up surveys
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to 12 months
Participants who elect to undergo endoscopic sinus surgery receive the surgical procedure and immediate post-operative care.
Visits at baseline, 3, 6, 9, and 12 months
Long-term Monitoring
Duration - 12 months
Participants who do not undergo surgery or after surgery are monitored to assess changes over time in pulmonary function, hospitalization days, quality of life, and olfaction.
Visits at baseline, 3, 6, 9, and 12 months
Trial Site Locations
Total: 9 locations
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
2
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
3
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
4
National Jewish Health
Denver, Colorado, United States, 80206
Actively Recruiting
5
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
6
Oregon Health Science University
Portland, Oregon, United States, 97239
Actively Recruiting
7
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
8
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
9
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
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Research Team
D
Daniel M Beswick, MD
M
Marlene Florian
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Impact of sinus surgery in people with cystic fibrosis and chronic rhinosinusitis in the era of highly effective modulator therapy: Protocol for a prospective observational study.
Christine M Liu, Jakob L Fischer, Jeremiah A Alt...
https://pubmed.ncbi.nlm.nih.gov/39325787Impact of sociodemographic status and sex on chronic rhinosinusitis and olfaction in people with cystic fibrosis.
Ethan J Han, Christine M Liu, Jakob L Fischer...
https://pubmed.ncbi.nlm.nih.gov/38967583