Impact of Sinus Surgery on Individuals With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

The Impact of Sinus Surgery in the Era of Highly Effective Modulatory Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04469439
• Other study ID #: 20-002079
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: January 31, 2025

Study information

• Verified date: September 2023
• Source: University of California, Los Angeles
• Contact: Daniel M Beswick, MD
• Phone: 310-206-8457
• Email: dbeswick[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Outcomes analyzed will include pulmonary, quality of life, and others.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis (Diagnosis)
• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	Change in days of inpatient hospitalization	Days of inpatient hospitalization will be assessed	baseline, 3, 6, 9, 12 months
Secondary	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
Secondary	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)	baseline, 3, 6, 9, 12 months
Secondary	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