Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET) (CABERNET)

Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients: A Randomized Controlled Study (CABERNET)

This post-market study aims to compare health outcomes for Recurrent Acute Rhinosinusitis (RARS) patients treated with balloon sinus dilation (BSD) versus medical management alone.

Study Overview

• Status: Completed
• Conditions: Recurrent Acute Rhinosinusitis
• Intervention / Treatment: Device: balloon sinus dilation; Other: medical therapy

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
  • Georgia
    • Atlanta, Georgia, United States, 30342
  • Nevada
    • Las Vegas, Nevada, United States, 89113
  • Texas
    • Dallas, Texas, United States, 75231
    • McKinney, Texas, United States, 75070

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 19 years of age or greater
• diagnosis of recurrent acute rhinosinusitis
• suitable candidate for office-based procedure
• willing and able to read and sign informed consent and remain compliant with protocol and study procedures
• able to read and understand English

Exclusion Criteria:

• diagnosis of chronic rhinosinusitis
• prior sinus surgery
• physician determined need for ancillary procedures
• known immune deficiency, ciliary dysfunction and/or autoimmune disease
• clinically significant illness that may interfere with evaluation of the study
• participation in clinical studies 6 months prior to study participation
• pregnant or lactating females

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: balloon sinus dilation; Balloon sinus dilation will be conducted in-office under local anesthesia.	Device: balloon sinus dilation; Other Names: balloon sinuplasty; Other: medical therapy; Other Names: medical management
Active Comparator: medical therapy; Medical therapy as needed per subject's specific disease and as determined by the investigators' clinical judgment.	Other: medical therapy; Other Names: medical management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CSS Total Score Change From Baseline to 24 Week Visit	The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey to evaluate surgical outcomes for CRS patients. The CSS asks three questions about symptoms and three questions about medication usage and yields a symptom subscore, a medication subscore, and a total score. Scale values include "0 Weeks" (minimum), "1-2 Weeks", "3-4 Weeks", "5-6 Weeks", and "7-8 Weeks" (maximum). The severity of symptoms is scored 0 (none) to 4 (severe), and a total score is calculated from 0 (worst) to 100 (best). Subscores are averaged to calculate a total score. Higher score indicates better outcomes. The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects randomized to BSD versus medical management only. Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score). Higher score indicates greater improvement.	24 Week Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks	The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("0 Weeks" (minimum) to "7-8 Weeks" (maximum)) used to evaluate surgical outcomes for CRS patients. The CSS asks 3 questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score. The symptom-based section contains pain or pressure, nasal congestion or difficulty to breathe through the nose, and rhinorrhea or postnasal drip. The medication-based section contains: antibiotics, prescription nasal sprays, and sinus medications in pill form. The severity of symptoms is scored 0 (none) to 4 (severe), and a total score is calculated from 0 (worst) to 100 (best). The Secondary Endpoint is the comparison of change as measured by average CSS medication and sinusitis symptom sub-scores over 24 and 48 weeks, and average total CSS score over 48 weeks for subjects randomized to BSD versus medical management. Higher score indicates greater improvement.	8, 16, 24, 32, 40, and 48 Weeks
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks	The Rhinosinusitis Disability Index (RSDI) is a 30-question survey which includes 3 individual subscales to measure physical, functional, and emotional scores as well as a total score. There is no specified recall period. Scale values include "Never" (minimum), "Almost Never", "Sometimes", "Almost Always", "Always" (maximum). RSDI scores range from 0 to 120. Subscores are averaged to calculate a total score. Higher score indicates increased impact of sinus disease. The Secondary Endpoint is comparison of change in patient-reported QOL as measured by RSDI total, physical, functional, and emotional sub-scores at 8, 24 and 48 weeks for subjects randomized to BSD versus medical management. Lower score indicates greater improvement (decreased impact of sinus disease).	8, 24, and 48 Weeks
Medication Usage at 24 and 48 Weeks	Comparison of medication usage at 24 and 48 weeks (days oral antibiotics, oral steroids, topical intranasal steroid sprays, and 'atypical' topical steroids (drops or respules)) for subjects randomized to BSD versus medical management.	24 Weeks and 48 Weeks
Unscheduled Medical Care Visits Due to Sinusitis	Comparison of unscheduled medical care visits due to sinusitis at 24 and 48 weeks for subjects randomized to BSD versus medical management.	24 Weeks and 48 Weeks
Sinus Infections and Sinus Severity - Part 1	Comparison of number of post-enrollment sinus infections for subjects randomized to BSD versus medical management.	24 Weeks and 48 Weeks
Sinus Infections and Sinus Severity - Part 2	Comparison of patient-reported sinus infection severity for subjects randomized to BSD versus medical management.	24 Weeks
Frequency of Second Procedure	Frequency of second procedure, ie the number of medical management subjects (sham arm) electing cross-over procedure.	Up to 24 weeks
Return to Normal Activity	Days until return to normal activity (RTNA) assessed at 2 weeks post-procedure	2 week

Collaborators and Investigators

• Sponsor: Acclarent
• Investigators: Principal Investigator: Ashley Sikand, MD, Ear Nose and Throat Consultants of Nevada; Principal Investigator: Ford Albritton, MD, Texas Institute for Sinus & Respiratory Disease

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: October 24, 2012
• First Submitted That Met QC Criteria: October 24, 2012
• First Posted (Estimate): October 26, 2012

Study Record Updates

• Last Update Posted (Actual): March 11, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Recurrence; Sinusitis
• Other Study ID Numbers: CPR005030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Publication planned in the future

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes