S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps (RESOLVE_II)
Primary Purpose
Chronic Sinusitis, Nasal Polyposis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
S8 Sinus Implant
Mometasone furoate nasal spray
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Sinusitis focused on measuring endoscopic sinus surgery, corticosteroid, chronic rhinosinusitis, mometasone furoate, polyposis
Eligibility Criteria
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
Sites / Locations
- The University of Alabama Birmingham
- Kaiser Permanente Orange County Irvine Medical Center
- Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc.
- Colorado ENT and Allergy
- Yale University School of Medicine
- GW Medical Facility Associates
- University of Miami
- South Florida ENT
- & Facial Plastic Surgery
- ENT of Georgia
- Northwestern Medical Faculty Foundation, Department of Otolaryngology
- DuPage Medical Group
- Iowa ENT Center
- University of Kansas Medical Center
- Advanced ENT and Allergy
- Associated Surgical Specialists
- Johns Hopkins
- Rontal Akervall Clinic
- University of Mississippi Medical Center
- Ear, Nose and Throat Consultants of Nevada
- Summit Medical Group
- Breathe America/NM Sinus
- Albany ENT & Allergy
- Madison ENT & Facial Plastic Surgery
- Mount Sinai Hospital
- Charlotte Eye, Ear, Nose and Throat Associates
- University of Oklahoma
- Bethlehem Ear, Nose and Throat Associates
- University of Pennsylvania
- Thomas Jefferson University Hospital
- Medical University of South Carolina
- Vanderbilt University
- University of Texas
- Cache Valley ENT
- Intermountain/ENT Center of UT
- University of Utah
- Eastern Virginia Medical School
- Reston ENT
- Virginia ENT
- Medical College of Wisconsin - Greenway Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treatment
Control
Arm Description
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses Mometasone furoate nasal spray (200mcg) once daily
In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02291549
Brief Title
S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intersect ENT
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis, Nasal Polyposis
Keywords
endoscopic sinus surgery, corticosteroid, chronic rhinosinusitis, mometasone furoate, polyposis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants were blindfolded and earmuffed during the baseline procedure and follow-up endoscopic examinations. Implants were removed at Day 60 to allow blinded assessment of bilateral polyp grade at Day 90 by a centralized videoendoscopy review by a panel of 3 independent sinus surgeons.
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Mometasone furoate nasal spray (200mcg) once daily
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
In-office bilateral sham procedure
Mometasone furoate nasal spray (200mcg) once daily
Intervention Type
Drug
Intervention Name(s)
S8 Sinus Implant
Other Intervention Name(s)
SINUVA (mometasone furoate) sinus implant
Intervention Description
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Intervention Type
Drug
Intervention Name(s)
Mometasone furoate nasal spray
Other Intervention Name(s)
Nasonex
Intervention Description
Mometasone furoate nasal spray (200mcg) once daily
Intervention Type
Procedure
Intervention Name(s)
Sham
Other Intervention Name(s)
Sham procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nasal Obstruction/Congestion Score
Description
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.
Time Frame
Day 30
Title
Bilateral Polyp Grade
Description
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.
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
Percentage of Patients Indicated for Repeat Endoscopic Sinus Surgery (RESS)
Description
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.
Time Frame
Day 90
Title
Ethmoid Sinus Obstruction
Description
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.
Time Frame
Day 90
Title
Nasal Obstruction/Congestion Score
Description
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.
Time Frame
Day 90
Title
Decreased Sense of Smell Score
Description
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.
Time Frame
Day 90
Title
Facial Pain/Pressure Score
Description
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.
Time Frame
Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert C Kern, MD
Organizational Affiliation
Department of Otolaryngology, Northwestern University, Chicago, IL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose P. Stolovitzky, MD
Organizational Affiliation
ENT of Georgia, Atlanta, GA
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Kaiser Permanente Orange County Irvine Medical Center
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc.
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Colorado ENT and Allergy
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
GW Medical Facility Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
South Florida ENT
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
& Facial Plastic Surgery
City
Riverview
State/Province
Florida
ZIP/Postal Code
33578
Country
United States
Facility Name
ENT of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northwestern Medical Faculty Foundation, Department of Otolaryngology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
DuPage Medical Group
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Iowa ENT Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Advanced ENT and Allergy
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Associated Surgical Specialists
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Rontal Akervall Clinic
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Ear, Nose and Throat Consultants of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Summit Medical Group
City
Berkeley Heights
State/Province
New Jersey
ZIP/Postal Code
07922
Country
United States
Facility Name
Breathe America/NM Sinus
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Albany ENT & Allergy
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Madison ENT & Facial Plastic Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Charlotte Eye, Ear, Nose and Throat Associates
City
Concord
State/Province
North Carolina
ZIP/Postal Code
29025
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Bethlehem Ear, Nose and Throat Associates
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Cache Valley ENT
City
North Logan
State/Province
Utah
ZIP/Postal Code
84341
Country
United States
Facility Name
Intermountain/ENT Center of UT
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Reston ENT
City
Reston
State/Province
Virginia
ZIP/Postal Code
20190
Country
United States
Facility Name
Virginia ENT
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Medical College of Wisconsin - Greenway Clinic
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29350840
Citation
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.
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S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps
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