ClinicalTrials.gg
RecruitingNCT04469439Updated Sep 10, 2026

Impact of Sinus Surgery on Individuals With Cystic Fibrosis

An observational study in Chronic Rhinosinusitis (Diagnosis) and Cystic Fibrosis, sponsored by University of California, Los Angeles. Recruiting at 9 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Primary conditionCystic FibrosisRegistry: DiseaseReclassifiedWhy we changed it
Registry
Disease — the first condition term the registry derived for this study.
ClinicalTrials.gg
Cystic Fibrosis
Why
  1. Disease describes something many studies share rather than a condition a study is about.
  2. The study's listed conditions name Cystic Fibrosis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of California, Los Angeles · Observational

From the registry’s dates

  • Started Jul 2020; still recruiting 6 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
170
Ages
18 Years to 99 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 716 studies in Cystic Fibrosis with a site in United States — 85 open to participants now, 110 under way, 8 of them phase 3. Cystic Fibrosis · United States.

Planned enrollment
56th of 193
170 · median 80
Started
2020
with 33 others
Observational
194 of 716
41 open now
Primary completion
2027-01
later than 39 of 107 live
Registered
548th of 716
by date

Among the 716 studies in Cystic Fibrosis with a site in United States, this one is the 56th largest by planned enrollment of the 193 observational ones, is one of 34 that started in 2020, is one of 194 observational ones, reaches primary completion later than 39 of the 107 other live ones, and was the 548th registered.

By phase

716 studies; the count open now beside each. This study's row is marked.

Observationalthis study194 · 41 open
No phase154 · 17 open
Phase 2103 · 10 open
Phase 3100 · 2 open
Phase 177 · 8 open
Phase 447 · 5 open
Phase 1/232 · 1 open
Phase 2/38 · 1 open
Other kind1 · 0 open

By the year they started

First in 1988; this study’s year is marked. 34 started in 2020.

Size and results

Median enrollment 36 across the 516 interventional studies, 80 across the 193 observational. Of the 569 that completed or were terminated, 263 (46%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 716 studies in Cystic Fibrosis with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Chronic Rhinosinusitis (Diagnosis)
  • Cystic Fibrosis

Browse trials for

Keywords

  • Chronic Rhinosinusitis
  • Cystic Fibrosis
  • Endoscopic Sinus Surgery
04

In context

Cystic Fibrosis Reclassified

1,619 studies on the registry are indexed under Cystic Fibrosis; 199 are open to participants now.

This study's planned enrollment of 170 is above the median of 85 across 503 observational studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.

Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.

Compared within Cystic Fibrosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
06

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
170 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

07

What researchers measure

Primary outcomes

  1. Change in pulmonary function

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

    Time frame: baseline, 3, 6, 9, 12 months

  2. Change in days of inpatient hospitalization

    Days of inpatient hospitalization will be assessed

    Time frame: baseline, 3, 6, 9, 12 months

Secondary outcomes

  1. 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)

    Time frame: baseline, 3, 6, 9, 12 months

  2. 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)

    Time frame: baseline, 3, 6, 9, 12 months

  3. Change in olfaction

    Olfaction will be assessed using the Smell Identification Test (score range: 0-40, with higher scores demonstrated better olfactory ability)

    Time frame: baseline, 3, 6, 9, 12 months

Other outcomes

  1. Patient satisfaction regarding treatment for chronic rhinosinusitis

    Satisfaction will be assessed using 5-point Likert scales, ranging from 1 to 5 with 1 signifying "not important" and 5 signifying "very important"

    Time frame: at baseline

08

Study locations

9 of 9 sites recruiting
09

References and documents

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 40156369 ↗
  • 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. PubMed 39325787 ↗
  • 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. PubMed 38967583 ↗
  • Miller 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 ↗

Individual participant data

Plan to share: No — Participant data will securely stored using REDCap software.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2020 (actual). Primary completion is estimated for Jan 2027, 78 months after the start.

Of 228 non-industry observational studies under Cystic Fibrosis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 89. This study's planned 78 months is above that.

Counting every sponsor, half of 243 studies reached it within 41 months; a quarter within 19 and three quarters within 79.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2020
First posted
Jul 14, 2020
StartActual
Jul 1, 2020
Primary completionEst.
Jan 31, 2027
CompletionEst.
Jan 31, 2027
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04469439
Collaborators
Cystic Fibrosis Foundation
Responsible party
Daniel M. Beswick (Assistant Professor-in-Residence, University of California, Los Angeles) — Principal investigator
First posted
Jul 14, 2020
Start date
Jul 1, 2020
Primary completion
Jan 31, 2027 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Daniel M Beswick, MD
Contact
dbeswick@mednet.ucla.edu
310-206-8457
Marlene Florian
Contact
mflorian@mednet.ucla.edu
424-946-5862
Daniel M Beswick, MD
principal investigator · University of California, Los Angeles

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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