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

Study Overview
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Brief Summary
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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.

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

Conditions
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Recurrent Acute Rhinosinusitis

Intervention / Treatment
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* Device: balloon sinus dilation
* Other: medical therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |