NCT04469439

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jul 2020Jan 2027

Study Start

First participant enrolled

July 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

April 22, 2026

Status Verified

July 1, 2025

Enrollment Period

6.6 years

First QC Date

July 9, 2020

Last Update Submit

April 17, 2026

Conditions

Chronic Rhinosinusitis (Diagnosis)Cystic Fibrosis

Keywords

Chronic RhinosinusitisCystic FibrosisEndoscopic Sinus Surgery

Outcome Measures

Primary Outcomes (2)

  • Change in pulmonary function

    Pulmonary function will be measured using spirometry - the percent of predicted forced expiratory volume in the first second (ppFEV1)

    baseline, 3, 6, 9, 12 months

  • Change in days of inpatient hospitalization

    Days of inpatient hospitalization will be assessed

    baseline, 3, 6, 9, 12 months

Secondary Outcomes (3)

  • Change in quality of life

    baseline, 3, 6, 9, 12 months

  • Change in quality of life

    baseline, 3, 6, 9, 12 months

  • Change in olfaction

    baseline, 3, 6, 9, 12 months

Other Outcomes (1)

  • Patient satisfaction regarding treatment for chronic rhinosinusitis

    at baseline

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be recruited from cystic fibrosis and otolaryngology outpatient clinics.

You may qualify if:

  • 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).
  • Diagnosed with cystic fibrosis as established by genetic testing combined with clinical assessment and/or sweat chloride
  • Diagnosed with chronic rhinosinusitis by multidisciplinary sinusitis guidelines
  • chronic rhinosinusitis symptoms persisting beyond initial medical treatment
  • Counseled for endoscopic sinus surgery and ongoing medical therapy with each patient electing their preferred treatment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Stanford University

Stanford, California, 94305, United States

RECRUITING

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Oregon Health Science University

Portland, Oregon, 97239, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 40156369DERIVED

  • 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.

    PMID: 39325787DERIVED

  • 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.

    PMID: 38967583DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Specimens are collected

MeSH Terms

Conditions

DiseaseCystic Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Daniel M Beswick, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel M Beswick, MD

CONTACT

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

Marlene Florian

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor-in-Residence

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 14, 2020

Study Start

July 1, 2020

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

April 22, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Participant data will securely stored using REDCap software.

Locations

US(9)