- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04469439
Impact of Sinus Surgery on Individuals With Cystic Fibrosis
September 29, 2023 updated by: Daniel M. Beswick, University of California, Los Angeles
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.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
170
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Daniel M Beswick, MD
- Phone Number: 310-206-8457
- Email: dbeswick@mednet.ucla.edu
Study Contact Backup
- Name: Karolin Markarian, BS
- Phone Number: 424-832-6099
- Email: kmarkarian@mednet.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Recruiting
- University of California, Los Angeles
-
Principal Investigator:
- Daniel M Beswick, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Subjects will be recruited from cystic fibrosis and otolaryngology outpatient clinics.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Underwent endoscopic sinus surgery in past 12 months
- Will obtain follow up care at non-participating institutions
- Unable to complete follow-up surveys
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
baseline, 3, 6, 9, 12 months
|
Change in days of inpatient hospitalization
Time Frame: baseline, 3, 6, 9, 12 months
|
Days of inpatient hospitalization will be assessed
|
baseline, 3, 6, 9, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of life
Time Frame: baseline, 3, 6, 9, 12 months
|
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
Time Frame: baseline, 3, 6, 9, 12 months
|
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
Time Frame: baseline, 3, 6, 9, 12 months
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction regarding treatment for chronic rhinosinusitis
Time Frame: at baseline
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Daniel M Beswick, MD, University of California, Los Angeles
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2020
Primary Completion (Estimated)
January 31, 2025
Study Completion (Estimated)
January 31, 2025
Study Registration Dates
First Submitted
July 9, 2020
First Submitted That Met QC Criteria
July 9, 2020
First Posted (Actual)
July 14, 2020
Study Record Updates
Last Update Posted (Actual)
October 2, 2023
Last Update Submitted That Met QC Criteria
September 29, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-002079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Participant data will securely stored using REDCap software.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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