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Impact of Sinus Surgery on Individuals With Cystic Fibrosis

The Impact of Sinus Surgery in the Era of Highly Effective Modulatory Therapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04469439
Enrollment
170
Registered
2020-07-14
Start date
2020-07-01
Completion date
2027-01-31
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinosinusitis (Diagnosis), Cystic Fibrosis

Keywords

Chronic Rhinosinusitis, Cystic Fibrosis, Endoscopic Sinus Surgery

Brief summary

This study will be a prospective, observational study of patients who undergo endoscopic sinus surgery for cystic fibrosis-related chronic rhinosinusitis (CRS). Individuals who do not undergo surgery but are treated medically for CRS will also be enrolled to serve as a control group. Outcomes analyzed will include pulmonary, quality of life, and others.

Interventions

None listed

Sponsors

University of California, Los Angeles
Lead SponsorOTHER
Cystic Fibrosis Foundation
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

1. Subjects between the ages of 18 years old (inclusive) and 99 years old (inclusive, subjects over the age of 89 will be recorded to be 89 years old). 2. Diagnosed with cystic fibrosis as established by genetic testing combined with clinical assessment and/or sweat chloride 3. Diagnosed with chronic rhinosinusitis by multidisciplinary sinusitis guidelines 4. chronic rhinosinusitis symptoms persisting beyond initial medical treatment 5. Counseled for endoscopic sinus surgery and ongoing medical therapy with each patient electing their preferred treatment

Exclusion criteria

1. Underwent endoscopic sinus surgery in past 12 months 2. Will obtain follow up care at non-participating institutions 3. Unable to complete follow-up surveys

Design outcomes

Primary

MeasureTime frameDescription
Change in pulmonary functionbaseline, 3, 6, 9, 12 monthsPulmonary function will be measured using spirometry - the percent of predicted forced expiratory volume in the first second (ppFEV1)
Change in days of inpatient hospitalizationbaseline, 3, 6, 9, 12 monthsDays of inpatient hospitalization will be assessed

Secondary

MeasureTime frameDescription
Change in quality of lifebaseline, 3, 6, 9, 12 monthsQuality of life will be assessed using the 22-question SinoNasal Outcome test (range 0-110, with higher scores signifying worse quality of life)
Change in olfactionbaseline, 3, 6, 9, 12 monthsOlfaction will be assessed using the Smell Identification Test (score range: 0-40, with higher scores demonstrated better olfactory ability)

Countries

United States

Contacts

CONTACTDaniel M Beswick, MD
dbeswick@mednet.ucla.edu310-206-8457
CONTACTMarlene Florian
mflorian@mednet.ucla.edu424-946-5862
PRINCIPAL_INVESTIGATORDaniel M Beswick, MD

University of California, Los Angeles

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026