Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps

NCT01732536 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: P500-1012
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 19

Brief Summary

The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic sinusitis patients with recurrent nasal polyps.

Conditions

Chronic Sinusitis; Nasal Polyps

Keywords

corticosteroid-eluting sinus implant; chronic rhinosinusitis; mometasone furoate; polyposis

Outcome Measures

Primary Outcomes (2)

• Nasal Obstruction/Congestion Score

  Nasal Obstruction by patients using a paper questionnaire on a scale from 0 (no problem) to 5 (problem as bad as it can be). Negative values for change from baseline represented reduction (improvement) in

  90 days

• Bilateral Polyp Grade

  Polyp grade was determined by a panel of 3 independent 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 represented reduction (improvement) in bilateral polyp grade.

  90 days

Secondary Outcomes (4)

• Ethmoid Sinus Obstruction

  90 days

• Bilateral Polyp Grade

  90 days, 6 months

• Nasal Obstruction Symptom Evaluation (NOSE) Score

  6 months

• Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS)

  90 days, 6 months

Study Arms (2)

S8 Sinus Implant

EXPERIMENTAL

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; Drug: Mometasone furoate nasal spray

Control

SHAM COMPARATOR

In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily

Procedure: Sham procedure; Drug: Mometasone furoate nasal spray

Interventions

S8 Sinus Implant DRUG

In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

Also known as: SINUVA (mometasone furoate) sinus implant

S8 Sinus Implant

Sham procedure PROCEDURE

In-office bilateral sham procedure

Control

Mometasone furoate nasal spray DRUG

Two sprays in each nostril once daily, totaling 200 mcg of mometasone furoate throughout Day 90

Also known as: Nasonex Nasal Spray

Control; S8 Sinus Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has provided written informed consent using a form approved by the reviewing IRB.
• Patient is ≥ 18 years of age.
• Patient is willing and able to comply with protocol requirements.
• Patient has a previous confirmed diagnosis of CS defined as inflammation of the mucosa of the paranasal sinuses.
• Patient has undergone bilateral total ethmoidectomy (must be at least 90 day beyond the date of last sinus surgery).
• Patient has recurrent bilateral sinus obstruction due to polyposis (Grades 1 through 3 only).
• Patient must have a Grade 2 polyposis on at least 1 ethmoid side.
• Patient is able to tolerate the use of Nasonex topical intranasal steroid spray once daily.
• Patient is indicated for a repeat ESS per the study definition. Patient must have: (i) a minimum symptom burden on the SNOT 22, consisting of a minimum score of 2 on at least 2 of the 5 hallmark symptoms of CS (nasal blockage, post-nasal discharge, thick nasal discharge, facial pain/pressure, and decreased sense of smell); (ii) persistent symptoms of CS despite ongoing treatment with topical intranasal steroid irrigations or sprays at least once daily for at least 2 weeks preceding enrollment; (iii) had treatment with a high-dose form of steroids (e.g., oral, parenteral, injection into polyps) and/or sinus steroid irrigations within the preceding 2 years, or refused such therapy due to intolerance/side effects; (iv) a known history of repeated courses of treatment with aggressive steroid therapy for recurrent sinusitis; and (v) endoscopic evidence of polyp recurrence, scarring, and/or obstructive mucosal edema.
• Patient is able to tolerate use of topical/local anesthesia and the implant procedure in an office or clinic setting.
• In the opinion of the physician, treatment with S8 Sinus Implant or sham procedure is technically feasible (able to pass 5-9 mm device into middle meatus) bilaterally.
• Female patients of child-bearing potential must not be pregnant and must agree to not become pregnant during the course of the study.
• Female patients of child-bearing potential must agree to use consistent and acceptable method/s of birth control during the course of the study.

You may not qualify if:

• Candidates were excluded if they met ANY of the following criteria:
• Patient had bilateral total ethmoidectomy less than 90 days previously.
• Patient had Propel implanted postoperatively less than 90 days previously.
• Patient has presence of adhesions/synechiae Grades 3 or 4.
• Patient has presence of severe scarring or adhesions within the ethmoid cavity itself.
• Patient has presence of Grade 4 polyposis.
• Patient has known history of immune deficiency (e.g., IGG\] subclass deficiency or IGA deficiency, HIV).
• Patient has concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease (e.g., cancer, HIV, etc.).
• Patient has oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD), asthma or other condition.
• Patient has known history of allergy or intolerance to corticosteroids or mometasone furoate (MF).
• Patient has known history of resistance or poor response to oral steroids.
• Patient has presence of physical obstruction that would preclude access to either ethmoid sinus for device 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 (e.g., acute increase in purulent discharge, fever, facial pain etc.).
• Patient has clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on prior CT scan, necrotic sinus tissue, etc.).
• Patient has evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 6 month follow-up period.

Sponsors & Collaborators

• Intersect ENT: lead

Study Sites (19)

California Sinus Centers

Atherton, California, 94027, United States

Location

Cedars-Sinai Medical Center, Sinus Center of Excellence

Los Angeles, California, 90048, United States

Location

Sacramento Ear, Nose and Throat

Sacramento, California, 95815, United States

Location

Colorado Ear, Nose, Throat & Allergy

Colorado Springs, Colorado, 80909, United States

Location

South Florida ENT Associates

Miami, Florida, 33176, United States

Location

ENT of Georgia

Atlanta, Georgia, 30342, United States

Location

Northwestern University, Department of Otolaryngology-Head & Neck Surgery

Chicago, Illinois, 60611, United States

Location

Advanced ENT & Allergy

Louisville, Kentucky, 40207, United States

Location

Summit Medical Group

Berkeley Heights, New Jersey, 07922, United States

Location

Albany ENT & Allergy Services

Albany, New York, 12206, United States

Location

ENT and Allergy Associates

Lake Success, New York, 11042, United States

Location

Piedmont Ear, Nose & Throat Associates

Winston-Salem, North Carolina, 27103, United States

Location

Oregon Health and Science University-Dept. of Otolaryngology Head and Neck Surgery

Portland, Oregon, 97239, United States

Location

Bethlehem ENT Specialty Physicians Associates

Bethlehem, Pennsylvania, 18017, United States

Location

University of Pennsylvania, Dept of Otolaryngology-Head & Neck Surgery

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Intermountain Ear, Nose & Throat Center

Salt Lake City, Utah, 84102, United States

Location

Eastern Virginia Medical School Department of Otolaryngology

Norfolk, Virginia, 23507, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53266, United States

Location

Related Publications (2)

• Han JK, Forwith KD, Smith TL, Kern RC, Brown WJ, Miller SK, Ow RA, Poetker DM, Karanfilov B, Matheny KE, Stambaugh J, Gawlicka AK. RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. Int Forum Allergy Rhinol. 2014 Nov;4(11):861-70. doi: 10.1002/alr.21426. Epub 2014 Sep 29.

  PMID: 25266981 BACKGROUND

• Forwith KD, Han JK, Stolovitzky JP, Yen DM, Chandra RK, Karanfilov B, Matheny KE, Stambaugh JW, Gawlicka AK. RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study. Int Forum Allergy Rhinol. 2016 Jun;6(6):573-81. doi: 10.1002/alr.21741. Epub 2016 Mar 14.

  PMID: 26992115 RESULT

MeSH Terms

Conditions

Nasal Polyps

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

1. Absence of defined medical regimen prior to enrollment 2. Investigators grading polyps and assessing indication for RESS were not blinded 3. Indication for RESS at baseline allowed for 1 sinus side to have polyp grade \>=1

Results Point of Contact

• Title: James Stambaugh, Vice President of Clinical & Medical Affairs
• Organization: Intersect ENT, Inc.

jstambaugh@intersectent.com

650-641-2103

Study Officials

• Keith D Forwith, MD

  Advanced ENT and Allergy

  PRINCIPAL INVESTIGATOR

• Joseph K Han, MD

  Eastern Virginia Medical School Department of Otolaryngology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 26, 2012
• Study Start: January 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: May 1, 2014
• Last Updated: July 20, 2018
• Results First Posted: July 20, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)