NCT02291549: RESOLVE_II

A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Sinus Obstruction

Completed Phase 3 Results posted Last updated 18 July 2018

What this trial tests

Phase 3 trial testing S8 Sinus Implant in Chronic Sinusitis in 300 participants. Completed in 1 October 2016.

Timeline

1 December 2014

Primary endpoint
1 October 2016

1 October 2016

Quick facts

Lead sponsor	Intersect ENT
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	300
Start date	1 December 2014
Primary completion	1 October 2016
Estimated completion	1 October 2016
Sites	40 locations across United States

Drugs / interventions tested

• S8 Sinus Implant — full drug profile →
• Mometasone furoate nasal spray — full drug profile →
• Sham

Conditions studied

• Chronic Sinusitis — all drugs for Chronic Sinusitis →
• Nasal Polyposis — all drugs for Nasal Polyposis →

Sponsor

Intersect ENT — full company profile →

Who can join

18 and older, any sex, with Chronic Sinusitis or Nasal Polyposis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps.
   Kern RC, Stolovitzky JP, Silvers SL, Singh A, et al · · 2018 · cited 53× · PMID 29350840 · DOI 10.1002/alr.22084