S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps

Study Overview
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Brief Summary
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The RESOLVE II Study is a randomized, single-blind, parallel arm, concurrently controlled, multicenter study with 300 chronic sinusitis patients who had prior endoscopic sinus surgery but present with recurrent sinus obstruction.

Detailed Description
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The RESOLVE II Study is a randomized, sham-controlled, double-blind, parallel arm multicenter trial conducted in up to 45 clinical centers (academic and private) across the United States in 300 adults with chronic sinusitis, who are indicated for revision surgery because of recurring nasal obstruction/congestion symptoms and bilateral ethmoid polyposis.

Official Title
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A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Sinus Obstruction

Conditions
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Chronic Sinusitis, Nasal Polyposis

Intervention / Treatment
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* Drug: S8 Sinus Implant
* Drug: Mometasone furoate nasal spray
* Procedure: Sham


Participation Criteria
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Eligibility Criteria
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Key inclusion criteria: Confirmed diagnosis of chronic sinusitis Patient has undergone bilateral total ethmoidectomy at least 90 days prior to screening Patient has Nasal Obstruction/Congestion score of at least 2 (scale from 0 to 3) on at least 5 days during the 7 days following informed consent, despite use of topical intranasal steroid irrigations or sprays for at least 14 days preceding scoring, as documented in medication records Indication for repeat ESS: Complaints of at least 2 symptoms of chronic sinusitis: nasal obstruction/congestion, post-nasal discharge, thick nasal discharge, facial pain/pressure, or decreased sense of smell Endoscopic evidence of bilateral sinus obstruction due to polyposis (minimum grade 2 on each side) History of high-dose steroid use and/or sinus steroid irrigations within the preceding 1 year Exclusion criteria: Patient has presence of polyposis grade 1, 1.5 or 4 on either side Patient has presence of adhesions/synechiae grades 3 or 4 Patient has known history of immune deficiency Patient has concurrent condition such as cancer or HIV requiring active chemotherapy and/or immunotherapy management for the disease Patient has oral-steroid dependent condition such as COPD, asthma or other condition Patient has known history of allergy or intolerance to corticosteroids or mometasone furoate Patient has presence of physical obstruction that would preclude access to either ethmoid sinus for implant delivery (e.g., severe septal deviation, septal spur, very small middle meatus, total obstruction of the nasal passage with severe scarring, polyposis) Patient has clinical evidence of acute bacterial sinusitis Patient has clinical evidence or suspicion of invasive fungal sinusitis Patient has evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90-day follow-up period Patient is currently participating in another clinical trial or has already participated in this clinical trial Patient has history of insulin dependent diabetes mellitus Patient has previously undergone ESS and experienced a cerebrospinal fluid (CSF) leak or has residual compromised vision as a result of a complication in a prior ESS procedure Patient has known dehiscence of the lamina papyracea Patient has evidence of active viral illness Patient has known history or diagnosis of glaucoma or ocular hypertension (prior ocular exam with IOP>21 mm Hg and pressure lowering medication given) or posterior subcapsular cataract

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses Mometasone furoate nasal spray (200mcg) once daily | Drug: S8 Sinus Implant<br>* In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses<br>* Other names: SINUVA (mometasone furoate) sinus implant;Drug: Mometasone furoate nasal spray<br>* Mometasone furoate nasal spray (200mcg) once daily<br>* Other names: Nasonex;|
| Sham Comparator: Control<br>In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily | Drug: Mometasone furoate nasal spray<br>* Mometasone furoate nasal spray (200mcg) once daily<br>* Other names: Nasonex;Procedure: Sham<br>* In-office bilateral sham procedure, consisting of advancement of a delivery system with the S8 Sinus Implant into the ethmoid sinuses followed by removal without deployment.<br>* Other names: Sham procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal Obstruction/Congestion Score | Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to the baseline and Day 30 visits. Negative values for change from baseline indicate reduction (improvement) in nasal obstruction/congestion symptoms. | Day 30 | 
| Bilateral Polyp Grade | Polyp grade was determined by an independent panel of 3 sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline indicated reduction (improvement) in bilateral polyp grade. | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Indicated for Repeat Endoscopic Sinus Surgery (RESS) | Proportion of patients still indicated for RESS at day 90 despite ongoing use of mometasone furoate nasal spray based on clinical investigator assessment using study-specific criteria. To be indicated for RESS, patients had to: (1) complain of nasal obstruction/congestion (moderate to severe) and postnasal discharge, facial pain/pressure/fullness, or altered sense of smell/taste; (2) have endoscopic evidence of persisting nasal polyps (grade >= 2 on each side); and (3) have received (required at baseline) or need a systemic steroid as noted during endoscopy. | Day 90 | 
| Ethmoid Sinus Obstruction | Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by an independent panel of 3 sinus surgeons based on a centralized, blinded videoendoscopy review using a 100-mm visual analogue scale (VAS), ranging from 0 (absence of obstruction) to 100 (complete obstruction). Negative values for change from baseline indicated reduction (improvement) in ethmoid sinus obstruction. | Day 90 | 
| Nasal Obstruction/Congestion Score | Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to baseline and Day 90. Negative values for change from baseline indicated reduction (improvement) in nasal obstruction/congestion symptoms. | Day 90 | 
| Decreased Sense of Smell Score | Determined by patients on a 6-point Likert scale from 0 (absent) to 5 (very severe). Negative values for change from baseline indicated reduction (improvement) in sense of smell. | Day 90 | 
| Facial Pain/Pressure Score | Determined by patients on a 6-point Likert scale from 0 (absent) to 5 (very severe). Negative values for change from baseline indicated reduction (improvement) in facial pain/pressure symptoms. | Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic sinus surgery, corticosteroid, chronic rhinosinusitis, mometasone furoate, polyposis