S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps (RESOLVE_II)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Sinusitis; Nasal Polyposis
• Intervention / Treatment: Drug: S8 Sinus Implant; Drug: Mometasone furoate nasal spray; Procedure: Sham

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • The University of Alabama Birmingham
  • California
    • Irvine, California, United States, 92618
      • Kaiser Permanente Orange County Irvine Medical Center
    • Sacramento, California, United States, 95815
      • Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Colorado ENT and Allergy
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University School Of Medicine
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • GW Medical Facility Associates
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
    • Miami, Florida, United States, 33176
      • South Florida ENT
    • Riverview, Florida, United States, 33578
      • & Facial Plastic Surgery
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • ENT of Georgia
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Faculty Foundation, Department of Otolaryngology
    • Naperville, Illinois, United States, 60540
      • DuPage Medical Group
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Iowa ENT Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Advanced ENT and Allergy
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Associated Surgical Specialists
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Rontal Akervall Clinic
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Ear, Nose and Throat Consultants of Nevada
  • New Jersey
    • Berkeley Heights, New Jersey, United States, 07922
      • Summit Medical Group
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Breathe America/NM Sinus
  • New York
    • Albany, New York, United States, 12206
      • Albany ENT & Allergy
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10016
      • Madison ENT & Facial Plastic surgery
  • North Carolina
    • Concord, North Carolina, United States, 29025
      • Charlotte Eye, Ear, Nose and Throat Associates
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Bethlehem Ear, Nose and Throat Associates
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas
  • Utah
    • North Logan, Utah, United States, 84341
      • Cache Valley ENT
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
    • Salt Lake City, Utah, United States, 84102
      • Intermountain/ENT Center of UT
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School
    • Reston, Virginia, United States, 20190
      • Reston ENT
    • Richmond, Virginia, United States, 23233
      • Virginia ENT
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53227
      • Medical College of Wisconsin - Greenway Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 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; In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses; Other Names: SINUVA (mometasone furoate) sinus implant; Drug: Mometasone furoate nasal spray; Mometasone furoate nasal spray (200mcg) once daily; Other Names: Nasonex
Sham Comparator: Control; In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily	Drug: Mometasone furoate nasal spray; Mometasone furoate nasal spray (200mcg) once daily; Other Names: Nasonex; 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.; Other Names: Sham procedure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Intersect ENT
• Investigators: Principal Investigator: Robert C Kern, MD, Department of Otolaryngology, Northwestern University, Chicago, IL; Principal Investigator: Jose P. Stolovitzky, MD, ENT of Georgia, Atlanta, GA

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: November 11, 2014
• First Submitted That Met QC Criteria: November 11, 2014
• First Posted (Estimate): November 14, 2014

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: corticosteroid; chronic rhinosinusitis; mometasone furoate; endoscopic sinus surgery; polyposis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Paranasal Sinus Diseases; Nose Diseases; Polyps; Sinusitis; Chronic Disease; Nasal Polyps; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Mometasone Furoate
• Other Study ID Numbers: P500-1113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No