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

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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

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.

Condition or disease Intervention/treatment Phase
Chronic Sinusitis Nasal Polyposis Drug: S8 Sinus Implant Drug: Mometasone furoate nasal spray Procedure: Sham Phase 3

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  (Clinical Trial)
Actual Enrollment : 300 participants
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
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
Actual Study Start Date : December 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

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 Name: SINUVA (mometasone furoate) sinus implant

Drug: Mometasone furoate nasal spray
Mometasone furoate nasal spray (200mcg) once daily
Other Name: 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 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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291549


  Show 40 Study Locations
Sponsors and Collaborators
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:
Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT02291549     History of Changes
Other Study ID Numbers: P500-1113
First Posted: November 14, 2014    Key Record Dates
Results First Posted: July 9, 2018
Last Update Posted: August 15, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Intersect ENT:
endoscopic sinus surgery
corticosteroid
chronic rhinosinusitis
mometasone furoate
polyposis

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Polyps
Pathological Conditions, Anatomical
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents