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A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps.

Abstract：

BACKGROUND:Topical intranasal corticosteroid sprays (INCSs) are standard treatment for nasal polyps (NPs), but their efficacy is reduced by poor patient compliance and impaired access of drug to the sinus mucosa. A corticosteroid-eluting sinus implant was designed to address these limitations in patients with recurrent polyposis after sinus surgery by delivering 1350 μg of mometasone furoate (MF) directly to the ethmoid sinus mucosa over approximately 90 days. METHODS:A randomized, sham-controlled, double-blind trial was undertaken in 300 adults with refractory chronic rhinosinusitis with NPs (CRSwNP), who were candidates for repeat surgery. Eligible patients were randomized (2:1) and underwent in-office bilateral placement of 2 implants or a sham procedure. All patients used the MF INCS 200 μg once daily. Co-primary efficacy endpoints were the change from baseline in nasal obstruction/congestion score and bilateral polyp grade, as determined by an independent panel based on centralized, blinded videoendoscopy review. RESULTS:Patients treated with implants experienced significant reductions in both nasal obstruction/congestion score (p = 0.0074) and bilateral polyp grade (p = 0.0073) compared to controls. At day 90, implants were also associated with significant reductions in 4 of 5 prespecified secondary endpoints compared to control: proportion of patients still indicated for repeat sinus surgery (p = 0.0004), percent ethmoid sinus obstruction (p = 0.0007), nasal obstruction/congestion (p = 0.0248), and decreased sense of smell (p = 0.0470), but not facial pain/pressure (p = 0.9130). One patient experienced an implant-related serious adverse event (epistaxis). CONCLUSION:Significant improvements over a range of subjective and objective endpoints, including a reduction in the need for sinus surgery by 61%, suggest that MF sinus implants may play an important role in management of recurrent NP.

journal_name

Int Forum Allergy Rhinol

journal_title

International forum of allergy & rhinology

authors

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.

doi

10.1002/alr.22084

subject

Has Abstract

pub_date

2018-04-01 00:00:00

pages

471-481

issue

eissn

2042-6976

issn

2042-6984

journal_volume

pub_type

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A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps.