Clinical trial NCT02291549: S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Sinusitis
Nasal Polyposis
Keywords: endoscopic sinus surgery
corticosteroid
chronic rhinosinusitis
mometasone furoate
polyposis
Lead sponsor: Intersect ENT
Sponsor class: INDUSTRY
First posted: 2014-11-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Nasal Obstruction/Congestion Score
timeFrame: Day 30
measure: Bilateral Polyp Grade
timeFrame: Day 90
Secondary outcomes:
measure: Percentage of Patients Indicated for Repeat Endoscopic Sinus Surgery (RESS)
timeFrame: Day 90
measure: Ethmoid Sinus Obstruction
timeFrame: Day 90
measure: Nasal Obstruction/Congestion Score
timeFrame: Day 90
measure: Decreased Sense of Smell Score
timeFrame: Day 90
measure: Facial Pain/Pressure Score
timeFrame: Day 90
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama Birmingham
state: Alabama
city: Irvine
country: United States
facility: Kaiser Permanente Orange County Irvine Medical Center
state: California
city: Sacramento
country: United States
facility: Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc.
state: California
city: Colorado Springs
country: United States
facility: Colorado ENT and Allergy
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Washington
country: United States
facility: GW Medical Facility Associates
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: South Florida ENT
state: Florida
city: Riverview
country: United States
facility: & Facial Plastic Surgery
state: Florida
city: Atlanta
country: United States
facility: ENT of Georgia
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation, Department of Otolaryngology
state: Illinois
city: Naperville
country: United States
facility: DuPage Medical Group
state: Illinois
city: West Des Moines
country: United States
facility: Iowa ENT Center
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Advanced ENT and Allergy
state: Kentucky
city: Covington
country: United States
facility: Associated Surgical Specialists
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Royal Oak
country: United States
facility: Rontal Akervall Clinic
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Las Vegas
country: United States
facility: Ear, Nose and Throat Consultants of Nevada
state: Nevada
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: Albuquerque
country: United States
facility: Breathe America/NM Sinus
state: New Mexico
city: Albany
country: United States
facility: Albany ENT & Allergy
state: New York
city: New York
country: United States
facility: Madison ENT & Facial Plastic Surgery
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Concord
country: United States
facility: Charlotte Eye, Ear, Nose and Throat Associates
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Bethlehem
country: United States
facility: Bethlehem Ear, Nose and Throat Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: University of Texas
state: Texas
city: North Logan
country: United States
facility: Cache Valley ENT
state: Utah
city: Salt Lake City
country: United States
facility: Intermountain/ENT Center of UT
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Reston
country: United States
facility: Reston ENT
state: Virginia
city: Richmond
country: United States
facility: Virginia ENT
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin - Greenway Clinic
state: Wisconsin
Study officials:
affiliation: Department of Otolaryngology, Northwestern University, Chicago, IL
name: Robert C Kern, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ENT of Georgia, Atlanta, GA
name: Jose P. Stolovitzky, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.