Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis

Study Overview
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Brief Summary
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This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.

Official Title
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Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis (MERLOT)

Conditions
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Sinusitis

Intervention / Treatment
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* Device: Balloon sinus dilation
* Drug: Medical Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged 19 or greater Diagnosis of Chronic Rhinosinusitis (CRS) Failure of appropriate medical management Radiographic evidence of inflammation of the paranasal sinuses Surgical candidate Willing and able to read and sign the Informed Consent Form and remain compliant with the protocol and study procedures Able to read and understand English Exclusion Criteria: Not suitable for balloon dilation for all peripheral sinuses that require treatment Clinically significant illness that may interfere with the evaluation of the study Patients involved in other clinical studies 30 days prior to study Pregnant or lactating females Patients unable to adhere to follow-up schedule or protocol requirements

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Balloon Sinus Dilation<br>Subjects with chronic sinusitis electing to have a balloon sinus dilation | Device: Balloon sinus dilation<br>* Subjects electing continued medical therapy group will not have balloon sinus dilation intervention. Subjects electing balloon sinus dilation group will have balloon sinus dilation intervention.<br>* Other names: Acclarent Balloon Sinuplasty System;|
| Medical Management<br>Subjects with chronic sinusitis electing to continue with medical therapy | Drug: Medical Management<br>* Subjects who select to continue on medical management rather than have a BSD procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline | The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey (during the past 8 weeks) to evaluate surgical outcomes for CRS patients. The CSS asks three questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score. The duration of symptoms is scored 0 (7-8 Weeks) to 4 (0 Weeks) and a total score is normalized from 0 (worst) to 100 (best). The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects electing BSD versus medical management. 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 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey (during the past 8 weeks) 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 duration of symptoms is scored 0 (7-8 Weeks) to 4 (0 Weeks), and a total score is normalized 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 at 12, 24, and 52 weeks , and average total CSS score at 12 and 52 weeks for subjects electing BSD versus medical management. Higher score indicates greater improvement. | 12, 24, and 52 weeks post treatment | 
| Change in RSDI | 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 are scored 0 (Never) to 4 (Always) and total score ranges from 0 (best) to 120 (worst). Subscores are summed 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 12, 24, and 52 weeks compared to baseline for subjects electing BSD versus medical management. Lower score indicates greater improvement (decreased impact of sinus disease). | 12, 24 and 52 weeks post treatment | 
| Change in SNOT-20 | The Sino-Nasal Outcome Test (SNOT-20) is a validated questionnaire consisting of 20 symptom-directed questions and quality of life and health utility assessments. Scale values range from 0 (No Problem) to 5 (Problem as bad as it can be). Lower score indicates greater improvement. | 12 weeks, 24 weeks, 52 weeks post treatment | 
| Change in Disease-specific Medication Usage |  | 12, 24 and 52 weeks post treatment | 
| Missed Days Work/School |  | 12, 24 and 52 weeks post treatment | 
| Number of Sinus-related Medical Care Visits |  | 12 weeks, 24 weeks, 52 weeks post treatment | 
| Number of Sinus Infections |  | 24 and 52 weeks | 
| Number of Subjects Requiring Revision for Subjects Electing BSD | A revision is defined as an endoscopic sinus surgery procedure on sinuses successfully dilated during index (BSD) procedure due to documented worsening of condition related to those sinuses after the index (BSD) procedure. | 52 weeks | 
| Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure |  | 52 weeks | 
| Post-operative Return to Normal Activity (RTNA) |  | 2 weeks post treatment |