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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline, 3, 6, 9, 12 months |
| Change in quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | at baseline |
Inclusion Criteria:
Exclusion Criteria:
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Subjects will be recruited from cystic fibrosis and otolaryngology outpatient clinics.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel M Beswick, MD | Contact | 310-206-8457 | dbeswick@mednet.ucla.edu | |
| Marlene Florian | Contact | 424-946-5862 | mflorian@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel M Beswick, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40156369 | Derived | 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. | |
| 39325787 |
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Participant data will securely stored using REDCap software.
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| ID | Term |
|---|---|
| D004194 | Disease |
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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Specimens are collected
Quality of life will be assessed using the Cystic Fibrosis Questionnaire-Revised instrument (range 0-100, with higher scores signifying worse quality of life)
| 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) | baseline, 3, 6, 9, 12 months |
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
| University of Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
| National Jewish Health | Recruiting | Denver | Colorado | 80206 | United States |
| University of North Carolina | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
| Oregon Health Science University | Recruiting | Portland | Oregon | 97239 | United States |
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
| University of Utah | Recruiting | Salt Lake City | Utah | 84132 | United States |
| Derived |
| 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. |
| 38967583 | Derived | 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. |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |