S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps

Chronic Sinusitis Clinical Trial

— RESOLVE_II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291549
• Other study ID #: P500-1113
• Status: Completed
• Phase: Phase 3
• Start date: December 2014
• Est. completion date: October 2016

Study information

• Verified date: July 2018
• Source: Intersect ENT
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinusitis
• Nasal Polyposis
• Nasal Polyps
• Sinusitis

Intervention

Drug:
• S8 Sinus Implant
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
• Mometasone furoate nasal spray
Mometasone furoate nasal spray (200mcg) once daily

Procedure:
• Sham
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.

Locations

Country	Name	City	State
United States	Albany ENT & Allergy	Albany	New York
United States	Breathe America/NM Sinus	Albuquerque	New Mexico
United States	ENT of Georgia	Atlanta	Georgia
United States	Johns Hopkins	Baltimore	Maryland
United States	Summit Medical Group	Berkeley Heights	New Jersey
United States	Bethlehem Ear, Nose and Throat Associates	Bethlehem	Pennsylvania
United States	The University of Alabama Birmingham	Birmingham	Alabama
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern Medical Faculty Foundation, Department of Otolaryngology	Chicago	Illinois
United States	Colorado ENT and Allergy	Colorado Springs	Colorado
United States	Charlotte Eye, Ear, Nose and Throat Associates	Concord	North Carolina
United States	Associated Surgical Specialists	Covington	Louisiana
United States	University of Texas	Houston	Texas
United States	Kaiser Permanente Orange County Irvine Medical Center	Irvine	California
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Ear, Nose and Throat Consultants of Nevada	Las Vegas	Nevada
United States	Advanced ENT and Allergy	Louisville	Kentucky
United States	South Florida ENT	Miami	Florida
United States	University of Miami	Miami	Florida
United States	Medical College of Wisconsin - Greenway Clinic	Milwaukee	Wisconsin
United States	DuPage Medical Group	Naperville	Illinois
United States	Vanderbilt University	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Madison ENT & Facial Plastic Surgery	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	Cache Valley ENT	North Logan	Utah
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Reston ENT	Reston	Virginia
United States	Virginia ENT	Richmond	Virginia
United States	& Facial Plastic Surgery	Riverview	Florida
United States	Rontal Akervall Clinic	Royal Oak	Michigan
United States	Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc.	Sacramento	California
United States	Intermountain/ENT Center of UT	Salt Lake City	Utah
United States	University of Utah	Salt Lake City	Utah
United States	GW Medical Facility Associates	Washington	District of Columbia
United States	Iowa ENT Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Intersect ENT

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kern RC, Stolovitzky JP, Silvers SL, Singh A, Lee JT, Yen DM, Iloreta AMC Jr, Langford FPJ, Karanfilov B, Matheny KE, Stambaugh JW, Gawlicka AK; RESOLVE II study investigators. A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps. Int Forum Allergy Rhinol. 2018 Apr;8(4):471-481. doi: 10.1002/alr.22084. Epub 2018 Jan 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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