Impact of Sinus Surgery on Individuals With Cystic Fibrosis

NCT ID: NCT04469439

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Rhinosinusitis (Diagnosis) Cystic Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgical group

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

No interventions assigned to this group

Medical group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cystic Fibrosis Foundation

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Daniel M. Beswick

Assistant Professor-in-Residence

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel M Beswick, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Stanford University

Stanford, California, United States

Site Status RECRUITING

University of Colorado

Aurora, Colorado, United States

Site Status RECRUITING

National Jewish Health

Denver, Colorado, United States

Site Status RECRUITING

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Oregon Health Science University

Portland, Oregon, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Daniel M Beswick, MD

Role: CONTACT

310-206-8457

Marlene Florian

Role: CONTACT

424-946-5862

Facility Contacts

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Marlene Florian

Role: primary

References

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Liu CM, Fischer JL, Lee MJ, Mace JC, Kimple AJ, Markarian K, Alt JA, Bodner TE, Chowdhury NI, Chung SY, Eshaghian PH, Gao YA, Getz AE, Hwang PH, Khanwalkar A, Lee JT, Li DA, Norris M, Nayak JV, Overdevest JB, Owens C, Patel ZM, Pappas LE, Poch K, Schlosser RJ, Smith KA, Smith TL, Soler ZM, Suh JD, Turner GA, Wang MB, Taylor-Cousar JL, Saavedra MT, Beswick DM. Olfaction, Eating Preference, and Quality of Life in Cystic Fibrosis Chronic Rhinosinusitis. Laryngoscope. 2025 Jul;135(7):2476-2488. doi: 10.1002/lary.32155. Epub 2025 Mar 29.

Reference Type DERIVED
PMID: 40156369 (View on PubMed)

Liu CM, Fischer JL, Alt JA, Bodner TE, Chowdhury NI, Getz AE, Hwang PH, Kimple AJ, Mace JC, Smith TL, Soler ZM, Goss CH, Taylor-Cousar JL, Saavedra MT, Beswick DM. 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. PLoS One. 2024 Sep 26;19(9):e0310986. doi: 10.1371/journal.pone.0310986. eCollection 2024.

Reference Type DERIVED
PMID: 39325787 (View on PubMed)

Han EJ, Liu CM, Fischer JL, Mace JC, Markarian K, Alt JA, Bodner TE, Chowdhury NI, Eshaghian PH, Gao YA, Getz AE, Hwang PH, Khanwalkar A, Kimple AJ, Lee JT, Li DA, Norris M, Nayak JV, Owens C, Patel ZM, Poch K, Schlosser RJ, Smith KA, Smith TL, Soler ZM, Suh JD, Turner GA, Wang MB, Taylor-Cousar JL, Saavedra MT, Beswick DM. Impact of sociodemographic status and sex on chronic rhinosinusitis and olfaction in people with cystic fibrosis. Int Forum Allergy Rhinol. 2024 Nov;14(11):1700-1713. doi: 10.1002/alr.23402. Epub 2024 Jul 5.

Reference Type DERIVED
PMID: 38967583 (View on PubMed)

Other Identifiers

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20-002079

Identifier Type: -

Identifier Source: org_study_id

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