S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps

Phase 3 Completed 300 enrolled Intersect ENT

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2014-12
Primary completion: 2016-10
Completion: 2016-10

Outcome

Met primary endpoint

registry analysis (superiority test); Treatment vs Control; p = 0.0074; Mean Difference (Final Values) -0.23 (95% CI -0.39 to -0.06) NCT02291549 ↗

registry analysis (superiority test); Treatment vs Control; p = 0.0073; Mean Difference (Final Values) -0.35 (95% CI -0.60 to -0.09) NCT02291549 ↗

Publications

Background 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	Mometasone furoate	Other / unclassified	1350 ug	Other
Background	Mometasone furoate	Other / unclassified	200 ug	Intranasal