RESOLVE: A randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis

Joseph K. Han, Keith D. Forwith, Timothy Smith, Robert C. Kern, William J. Brown, Steven K. Miller, Randall A. Ow, David M. Poetker, Boris Karanfilov, Keith E. Matheny, James Stambaugh, Anna K. Gawlicka

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

Background: Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. This study evaluated the safety and efficacy of a bioabsorbable steroid-eluting implant with 1350 μg of mometasone furoate for its ability to dilate obstructed ethmoid sinuses, reduce polyposis, and reestablish sinus patency. Methods: This was a randomized, controlled, blinded study including 100 patients chronic rhinosinusitis with nasal polyposis (CRSwNP) refractory to medical therapy and considered candidates for revision ESS. Follow-up included endoscopic grading by investigators and patient-reported outcomes. Results: Treated patients (n = 53; age as mean ± standard deviation [SD] 47.8 ± 12.6 years; 55% male) underwent in-office bilateral placement. Control patients (n = 47; age 51.6 ± 13.1 years; 66% male) underwent a sham procedure. At 3 months, treated patients experienced a significant reduction in bilateral polyp grade (p = 0.0269) and ethmoid sinus obstruction (p = 0.0001) compared to controls. Treated patients also experienced a 2-fold improvement in the mean nasal obstruction/congestion score (-1.33 ± 1.47 vs -0.67 ± 1.45; p = 0.1365). This improvement reached statistical significance (p = 0.025) in patients with greater polyp burden (grade ≥2 bilaterally; n = 74). At 3 months, 53% of treated patients compared to only 23% of controls were no longer indicated for repeat ESS. There was no serious adverse event or clinically significant increases in intraocular pressure or cataract formation. Conclusion: The symptomatic improvement and statistically significant reduction in polyp grade and ethmoid sinus obstruction supported the efficacy of the steroid-eluting implant for in-office treatment of CRS patient with recurrent polyposis after ESS. The study results demonstrated that the steroid-eluting implant represents a safe and effective alternative to current management for this patient population.

Original languageEnglish (US)
Pages (from-to)861-870
Number of pages10
JournalInternational Forum of Allergy and Rhinology
Volume4
Issue number11
DOIs
StatePublished - Nov 1 2014

Fingerprint

Steroids
Ethmoid Sinus
Polyps
Therapeutics
Mometasone Furoate
Nasal Obstruction
Intraocular Pressure
Nose
Cataract
Research Personnel
Safety
Population

Keywords

  • Corticosteroid
  • CRSwNP
  • Drug-eluting
  • Efficacy
  • Endoscopic sinus surgery
  • Mometasone furoate
  • Nasal polyps
  • Refractory
  • Safety
  • Sinusitis

ASJC Scopus subject areas

  • Immunology and Allergy
  • Otorhinolaryngology
  • Medicine(all)

Cite this

RESOLVE : A randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. / Han, Joseph K.; Forwith, Keith D.; Smith, Timothy; Kern, Robert C.; Brown, William J.; Miller, Steven K.; Ow, Randall A.; Poetker, David M.; Karanfilov, Boris; Matheny, Keith E.; Stambaugh, James; Gawlicka, Anna K.

In: International Forum of Allergy and Rhinology, Vol. 4, No. 11, 01.11.2014, p. 861-870.

Research output: Contribution to journalArticle

Han, JK, Forwith, KD, Smith, T, Kern, RC, Brown, WJ, Miller, SK, Ow, RA, Poetker, DM, Karanfilov, B, Matheny, KE, Stambaugh, J & Gawlicka, AK 2014, 'RESOLVE: A randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis', International Forum of Allergy and Rhinology, vol. 4, no. 11, pp. 861-870. https://doi.org/10.1002/alr.21426
Han, Joseph K. ; Forwith, Keith D. ; Smith, Timothy ; Kern, Robert C. ; Brown, William J. ; Miller, Steven K. ; Ow, Randall A. ; Poetker, David M. ; Karanfilov, Boris ; Matheny, Keith E. ; Stambaugh, James ; Gawlicka, Anna K. / RESOLVE : A randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. In: International Forum of Allergy and Rhinology. 2014 ; Vol. 4, No. 11. pp. 861-870.
@article{4db1609a9911434fa047e9addbdf3aa1,
title = "RESOLVE: A randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis",
abstract = "Background: Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. This study evaluated the safety and efficacy of a bioabsorbable steroid-eluting implant with 1350 μg of mometasone furoate for its ability to dilate obstructed ethmoid sinuses, reduce polyposis, and reestablish sinus patency. Methods: This was a randomized, controlled, blinded study including 100 patients chronic rhinosinusitis with nasal polyposis (CRSwNP) refractory to medical therapy and considered candidates for revision ESS. Follow-up included endoscopic grading by investigators and patient-reported outcomes. Results: Treated patients (n = 53; age as mean ± standard deviation [SD] 47.8 ± 12.6 years; 55{\%} male) underwent in-office bilateral placement. Control patients (n = 47; age 51.6 ± 13.1 years; 66{\%} male) underwent a sham procedure. At 3 months, treated patients experienced a significant reduction in bilateral polyp grade (p = 0.0269) and ethmoid sinus obstruction (p = 0.0001) compared to controls. Treated patients also experienced a 2-fold improvement in the mean nasal obstruction/congestion score (-1.33 ± 1.47 vs -0.67 ± 1.45; p = 0.1365). This improvement reached statistical significance (p = 0.025) in patients with greater polyp burden (grade ≥2 bilaterally; n = 74). At 3 months, 53{\%} of treated patients compared to only 23{\%} of controls were no longer indicated for repeat ESS. There was no serious adverse event or clinically significant increases in intraocular pressure or cataract formation. Conclusion: The symptomatic improvement and statistically significant reduction in polyp grade and ethmoid sinus obstruction supported the efficacy of the steroid-eluting implant for in-office treatment of CRS patient with recurrent polyposis after ESS. The study results demonstrated that the steroid-eluting implant represents a safe and effective alternative to current management for this patient population.",
keywords = "Corticosteroid, CRSwNP, Drug-eluting, Efficacy, Endoscopic sinus surgery, Mometasone furoate, Nasal polyps, Refractory, Safety, Sinusitis",
author = "Han, {Joseph K.} and Forwith, {Keith D.} and Timothy Smith and Kern, {Robert C.} and Brown, {William J.} and Miller, {Steven K.} and Ow, {Randall A.} and Poetker, {David M.} and Boris Karanfilov and Matheny, {Keith E.} and James Stambaugh and Gawlicka, {Anna K.}",
year = "2014",
month = "11",
day = "1",
doi = "10.1002/alr.21426",
language = "English (US)",
volume = "4",
pages = "861--870",
journal = "International Forum of Allergy and Rhinology",
issn = "2042-6976",
publisher = "Wiley-Blackwell",
number = "11",

}

TY - JOUR

T1 - RESOLVE

T2 - A randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis

AU - Han, Joseph K.

AU - Forwith, Keith D.

AU - Smith, Timothy

AU - Kern, Robert C.

AU - Brown, William J.

AU - Miller, Steven K.

AU - Ow, Randall A.

AU - Poetker, David M.

AU - Karanfilov, Boris

AU - Matheny, Keith E.

AU - Stambaugh, James

AU - Gawlicka, Anna K.

PY - 2014/11/1

Y1 - 2014/11/1

N2 - Background: Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. This study evaluated the safety and efficacy of a bioabsorbable steroid-eluting implant with 1350 μg of mometasone furoate for its ability to dilate obstructed ethmoid sinuses, reduce polyposis, and reestablish sinus patency. Methods: This was a randomized, controlled, blinded study including 100 patients chronic rhinosinusitis with nasal polyposis (CRSwNP) refractory to medical therapy and considered candidates for revision ESS. Follow-up included endoscopic grading by investigators and patient-reported outcomes. Results: Treated patients (n = 53; age as mean ± standard deviation [SD] 47.8 ± 12.6 years; 55% male) underwent in-office bilateral placement. Control patients (n = 47; age 51.6 ± 13.1 years; 66% male) underwent a sham procedure. At 3 months, treated patients experienced a significant reduction in bilateral polyp grade (p = 0.0269) and ethmoid sinus obstruction (p = 0.0001) compared to controls. Treated patients also experienced a 2-fold improvement in the mean nasal obstruction/congestion score (-1.33 ± 1.47 vs -0.67 ± 1.45; p = 0.1365). This improvement reached statistical significance (p = 0.025) in patients with greater polyp burden (grade ≥2 bilaterally; n = 74). At 3 months, 53% of treated patients compared to only 23% of controls were no longer indicated for repeat ESS. There was no serious adverse event or clinically significant increases in intraocular pressure or cataract formation. Conclusion: The symptomatic improvement and statistically significant reduction in polyp grade and ethmoid sinus obstruction supported the efficacy of the steroid-eluting implant for in-office treatment of CRS patient with recurrent polyposis after ESS. The study results demonstrated that the steroid-eluting implant represents a safe and effective alternative to current management for this patient population.

AB - Background: Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. This study evaluated the safety and efficacy of a bioabsorbable steroid-eluting implant with 1350 μg of mometasone furoate for its ability to dilate obstructed ethmoid sinuses, reduce polyposis, and reestablish sinus patency. Methods: This was a randomized, controlled, blinded study including 100 patients chronic rhinosinusitis with nasal polyposis (CRSwNP) refractory to medical therapy and considered candidates for revision ESS. Follow-up included endoscopic grading by investigators and patient-reported outcomes. Results: Treated patients (n = 53; age as mean ± standard deviation [SD] 47.8 ± 12.6 years; 55% male) underwent in-office bilateral placement. Control patients (n = 47; age 51.6 ± 13.1 years; 66% male) underwent a sham procedure. At 3 months, treated patients experienced a significant reduction in bilateral polyp grade (p = 0.0269) and ethmoid sinus obstruction (p = 0.0001) compared to controls. Treated patients also experienced a 2-fold improvement in the mean nasal obstruction/congestion score (-1.33 ± 1.47 vs -0.67 ± 1.45; p = 0.1365). This improvement reached statistical significance (p = 0.025) in patients with greater polyp burden (grade ≥2 bilaterally; n = 74). At 3 months, 53% of treated patients compared to only 23% of controls were no longer indicated for repeat ESS. There was no serious adverse event or clinically significant increases in intraocular pressure or cataract formation. Conclusion: The symptomatic improvement and statistically significant reduction in polyp grade and ethmoid sinus obstruction supported the efficacy of the steroid-eluting implant for in-office treatment of CRS patient with recurrent polyposis after ESS. The study results demonstrated that the steroid-eluting implant represents a safe and effective alternative to current management for this patient population.

KW - Corticosteroid

KW - CRSwNP

KW - Drug-eluting

KW - Efficacy

KW - Endoscopic sinus surgery

KW - Mometasone furoate

KW - Nasal polyps

KW - Refractory

KW - Safety

KW - Sinusitis

UR - http://www.scopus.com/inward/record.url?scp=84933522459&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84933522459&partnerID=8YFLogxK

U2 - 10.1002/alr.21426

DO - 10.1002/alr.21426

M3 - Article

C2 - 25266981

AN - SCOPUS:84933522459

VL - 4

SP - 861

EP - 870

JO - International Forum of Allergy and Rhinology

JF - International Forum of Allergy and Rhinology

SN - 2042-6976

IS - 11

ER -