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

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

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

Study Overview

• Status: Completed
• Conditions: Sinusitis
• Intervention / Treatment: Device: Balloon sinus dilation; Drug: Medical Management

• Study Type: Observational
• Enrollment (Actual): 198

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States
  • Florida
    • Miami, Florida, United States
    • Tampa, Florida, United States
  • Georgia
    • Atlanta, Georgia, United States
    • Savannah, Georgia, United States
    • Vidalia, Georgia, United States
  • Illinois
    • Chicago, Illinois, United States
    • Rockford, Illinois, United States
  • Indiana
    • South Bend, Indiana, United States
  • Kentucky
    • Louisville, Kentucky, United States
  • New Jersey
    • Neptune, New Jersey, United States
  • Ohio
    • Dublin, Ohio, United States
  • Texas
    • Frisco, Texas, United States
    • McKinney, Texas, United States
    • Plano, Texas, United States
  • Virginia
    • Charlottesville, Virginia, United States
    • Norfolk, Virginia, United States
    • Richmond, Virginia, United States
  • Wisconsin
    • Beaver Dam, Wisconsin, United States
    • Wauwatosa, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects age 19 or older with radiographically documented CRS

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Balloon Sinus Dilation; Subjects with chronic sinusitis electing to have a balloon sinus dilation	Device: Balloon sinus dilation; 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.; Other Names: Acclarent Balloon Sinuplasty System
Medical Management; Subjects with chronic sinusitis electing to continue with medical therapy	Drug: Medical Management; Subjects who select to continue on medical management rather than have a BSD procedure.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Collaborators: Acclarent
• Investigators: Principal Investigator: Spencer Payne, MD, University of Virginia; Principal Investigator: Christopher Melroy, MD, Georgia Nasal and Sinus Institute; Principal Investigator: Boris Karanfilov, MD, Ohio Sinus Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2012
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: September 12, 2012
• First Posted (Estimated): September 14, 2012

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Rhinitis; Sinusitis; Rhinosinusitis
• Other Study ID Numbers: CPR005028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publication is planned