Chronic Rhinosinusitis (Diagnosis)NCT04469439
Impact of Sinus Surgery on Individuals With Cystic Fibrosis
An observational study of Chronic Rhinosinusitis (Diagnosis) and Cystic Fibrosis, run by University of California, Los Angeles at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis), Cystic Fibrosis
- How many people
- 170 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Jul 2020to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from cystic fibrosis and otolaryngology outpatient clinics.
Who may be able to join
- 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
Who cannot join
- Underwent endoscopic sinus surgery in past 12 months
- Will obtain follow up care at non-participating institutions
- Unable to complete follow-up surveys
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27514
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
- Recruiting
National Jewish Health
Denver, Colorado, 80206
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Marlene Florian, mflorian@mednet.ucla.edu
Daniel M Beswick, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
- Recruiting
Oregon Health Science University
Portland, Oregon, 97239
- Recruiting
University of Utah
Salt Lake City, Utah, 84132
- Recruiting
Stanford University
Stanford, California, 94305
About this study
Official title: The Impact of Sinus Surgery in the Era of Highly Effective Modulatory Therapy
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.
- Keywords
- Chronic Rhinosinusitis, Cystic Fibrosis, Endoscopic Sinus Surgery
- Medical subject headings
- Disease, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pulmonary function
Pulmonary function will be measured using spirometry - the percent of predicted forced expiratory volume in the first second (ppFEV1)
Measured: baseline, 3, 6, 9, 12 months
Change in days of inpatient hospitalization
Days of inpatient hospitalization will be assessed
Measured: baseline, 3, 6, 9, 12 months
Secondary outcomes (3)
Change in quality of life
Quality of life will be assessed using the 22-question SinoNasal Outcome test (range 0-110, with higher scores signifying worse quality of life)
Measured: baseline, 3, 6, 9, 12 months
Change in quality of life
Quality of life will be assessed using the Cystic Fibrosis Questionnaire-Revised instrument (range 0-100, with higher scores signifying worse quality of life)
Measured: baseline, 3, 6, 9, 12 months
Change in olfaction
Olfaction will be assessed using the Smell Identification Test (score range: 0-40, with higher scores demonstrated better olfactory ability)
Measured: baseline, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Jul 2020
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Principal investigator, Daniel M. Beswick, University of California, Los Angeles
- Investigators
- Daniel M Beswick, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469439
- Sponsor's protocol ID
- 20-002079
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2020
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will securely stored using REDCap software.
Publications
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.
PubMed 40156369Liu 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.
PubMed 39325787Han 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.
PubMed 38967583Miller JE, Taylor-Cousar JL, Overdevest JB, Khatiwada A, Mace JC, Alt JA, Bodner TE, Chowdhury NI, DiMango EA, Eshaghian PH, Getz AE, Gudis DA, Han EJ, Hwang PH, Keating CL, Khanwalkar A, Kimple AJ, Lee JT, Li D, Markarian K, Norris M, Nayak JV, Owens C, Patel ZM, Poch K, Schlosser RJ, Smith KA, Smith TL, Soler ZM, Suh JD, Tervo JP, Turner GA, Wang MB, Saavedra MT, Beswick DM. Determining the minimal clinically important difference for the questionnaire of olfactory disorders in people with cystic fibrosis and factors associated with improvement after highly effective modulator therapy. Int Forum Allergy Rhinol. 2024 Jun;14(6):1079-1087. doi: 10.1002/alr.23312. Epub 2023 Dec 25.
PubMed 38145393
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sinus Surgery in the Era of Highly Effective Modulatory Therapy
- ClinicalTrials.gov ID
- NCT04469439
- Acronym / sponsor ID
- 20-002079
- Keywords
- Chronic Rhinosinusitis, Cystic Fibrosis, Endoscopic Sinus Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from cystic fibrosis and otolaryngology outpatient clinics.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Underwent endoscopic sinus surgery in past 12 months
- Will obtain follow up care at non-participating institutions
- Unable to complete follow-up surveys
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in pulmonary function
Time frame: baseline, 3, 6, 9, 12 months
Pulmonary function will be measured using spirometry - the percent of predicted forced expiratory volume in the first second (ppFEV1)
Change in days of inpatient hospitalization
Time frame: baseline, 3, 6, 9, 12 months
Days of inpatient hospitalization will be assessed
3 secondary outcomes
Change in quality of life
Time frame: baseline, 3, 6, 9, 12 months
Change in quality of life
Time frame: baseline, 3, 6, 9, 12 months
Change in olfaction
Time frame: baseline, 3, 6, 9, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Derived from this study: PubMed 40156369Liu 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.
- Derived from this study: PubMed 39325787Liu 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.
- Derived from this study: PubMed 38967583Han 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.
- Derived from this study: PubMed 38145393Miller JE, Taylor-Cousar JL, Overdevest JB, Khatiwada A, Mace JC, Alt JA, Bodner TE, Chowdhury NI, DiMango EA, Eshaghian PH, Getz AE, Gudis DA, Han EJ, Hwang PH, Keating CL, Khanwalkar A, Kimple AJ, Lee JT, Li D, Markarian K, Norris M, Nayak JV, Owens C, Patel ZM, Poch K, Schlosser RJ, Smith KA, Smith TL, Soler ZM, Suh JD, Tervo JP, Turner GA, Wang MB, Saavedra MT, Beswick DM. Determining the minimal clinically important difference for the questionnaire of olfactory disorders in people with cystic fibrosis and factors associated with improvement after highly effective modulator therapy. Int Forum Allergy Rhinol. 2024 Jun;14(6):1079-1087. doi: 10.1002/alr.23312. Epub 2023 Dec 25.
- Individual participant dataSharing planned: No. Participant data will securely stored using REDCap software.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel M Beswick, MD principal investigator
University of California, Los Angeles
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis (Diagnosis) and Cystic Fibrosis, run by University of California, Los Angeles at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel M Beswick, MD (310-206-8457, dbeswick@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pulmonary function (time frame: baseline, 3, 6, 9, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04469439, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.