Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis

Sinusitis Clinical Trial

— MERLOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685229
• Other study ID #: CPR005028
• Status: Completed
• Start date: September 1, 2012
• Est. completion date: August 1, 2015

Study information

• Verified date: February 2019
• Source: Acclarent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: August 1, 2015
• Est. primary completion date: April 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sinusitis

Intervention

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.

Drug:
• Medical Management
Subjects who select to continue on medical management rather than have a BSD procedure.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Acclarent

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in Disease-specific Medication Usage		12, 24 and 52 weeks post treatment
Secondary	Missed Days Work/School		12, 24 and 52 weeks post treatment
Secondary	Number of Sinus-related Medical Care Visits		12 weeks, 24 weeks, 52 weeks post treatment
Secondary	Number of Sinus Infections		24 and 52 weeks
Secondary	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
Secondary	Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure		52 weeks
Secondary	Post-operative Return to Normal Activity (RTNA)		2 weeks post treatment