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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291549
Recruitment Status : Completed
First Posted : November 14, 2014
Results First Posted : July 9, 2018
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Intersect ENT

Tracking Information
First Submitted Date  ICMJE November 11, 2014
First Posted Date  ICMJE November 14, 2014
Results First Submitted Date  ICMJE April 16, 2018
Results First Posted Date  ICMJE July 9, 2018
Last Update Posted Date August 15, 2018
Actual Study Start Date  ICMJE December 2014
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2018)
  • Nasal Obstruction/Congestion Score [ Time Frame: Day 30 ]
    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 [ Time Frame: Day 90 ]
    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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
  • Percentage of Patients Indicated for Repeat Endoscopic Sinus Surgery (RESS) [ Time Frame: Day 90 ]
    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 [ Time Frame: Day 90 ]
    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 [ Time Frame: Day 90 ]
    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 [ Time Frame: Day 90 ]
    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 [ Time Frame: Day 90 ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps
Official Title  ICMJE A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Sinus Obstruction
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes 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.
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Sinusitis
  • Nasal Polyposis
Intervention  ICMJE
  • Drug: S8 Sinus Implant
    In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
    Other Name: SINUVA (mometasone furoate) sinus implant
  • Drug: Mometasone furoate nasal spray
    Mometasone furoate nasal spray (200mcg) once daily
    Other Name: 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 Name: Sham procedure
Study Arms  ICMJE
  • 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

    Interventions:
    • Drug: S8 Sinus Implant
    • Drug: Mometasone furoate nasal spray
  • Sham Comparator: Control

    In-office bilateral sham procedure

    Mometasone furoate nasal spray (200mcg) once daily

    Interventions:
    • Drug: Mometasone furoate nasal spray
    • Procedure: Sham
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2015)
300
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02291549
Other Study ID Numbers  ICMJE P500-1113
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Intersect ENT
Study Sponsor  ICMJE Intersect ENT
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert C Kern, MD Department of Otolaryngology, Northwestern University, Chicago, IL
Principal Investigator: Jose P. Stolovitzky, MD ENT of Georgia, Atlanta, GA
PRS Account Intersect ENT
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP