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

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

Study Contact Backup

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:

  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

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.

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

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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