Recruiting

Sinus SurgeryImpact of Sinus Surgery on Individuals With Cystic Fibrosis

Sponsor:

UCLA

Code:

NCT04469439

Conditions

Chronic Rhinosinusitis (Diagnosis)

Cystic Fibrosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Cystic Fibrosis

Study ID

NCT04469439

Start date

Jul 1, 2020

Status verified date

Jul, 2025

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

170 participants

Anticipated

Interventions and Outcome Measures

Arms

Surgical group

Individuals with cystic fibrosis and chronic rhinosinusitis who undergo endoscopic sinus surgery

Medical group

Individuals with cystic fibrosis and chronic rhinosinusitis who do not undergo endoscopic sinus surgery

Primary outcome measure

Change in pulmonary function [ Time Frame: baseline, 3, 6, 9, 12 months ]
Change in days of inpatient hospitalization [ Time Frame: baseline, 3, 6, 9, 12 months ]

Central Contacts and Locations

Central contacts

Daniel M Beswick, MD

310-206-8457 dbeswick@mednet.ucla.edu

Marlene Florian

424-946-5862 mflorian@mednet.ucla.edu

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Marlene Florian

mflorian@mednet.ucla.edu

Principal Investigator:

Daniel M Beswick, MD

Stanford University

Recruiting

Stanford, California, United States, 94305

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27514

Oregon Health Science University

Recruiting

Portland, Oregon, United States, 97239

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

More Information

Sponsor

University of California, Los Angeles

Last update posted

Apr 22, 2026

Last verified

Jul, 2025

Keywords

Chronic Rhinosinusitis
Cystic Fibrosis
Endoscopic Sinus Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-04-22.