Evidence map›Paper›PMID 29350840›Full record

Trial reportInternational forum of allergy & rhinology2018

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

Robert C Kern, J Pablo Stolovitzky, Stacey L Silvers, Ameet Singh, Jivianne T Lee, David M Yen, Alfred M C Iloreta, Francis P J Langford, Boris Karanfilov, Keith E Matheny and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in International forum of allergy & rhinology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02291549 (A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Sinus Obstruction), which is not on this map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
8.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02291549 phase3completednot on this map

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

TypeinterventionalSponsorIntersect ENTRan2014 to 2016Enrolled300ConditionsChronic Sinusitis, Nasal PolyposisArmsS8 Sinus Implant, Mometasone furoate nasal spray, Sham
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 81 citations in OpenAlex.

  1. Assessing the effect of absorbable steroid sinus implant: a state-of-the-art systematic review.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024
    Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Chinese Guidelines for Diagnosis and Treatment of Chronic Rhinosinusitis (2024).World journal of otorhinolaryngology - head and neck surgery · 2026
    Article
  7. Article
  8. [Effects of different surgical methods on the application of topical hormones in the sinus after operation].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2024
    Review
  9. The efficacy of steroid-eluting stents on the local inflammation of chronic rhinosinusitis with nasal polyposis after endoscopic sinus surgery: a multicenter prospective longitudinal study.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2023
    Article
  10. [Clinical treatment options oriented to the endotype of chronic rhinosinusitis].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2023
    Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Perspectives in Therapy of Chronic Rhinosinusitis.Diagnostics (Basel, Switzerland) · 2022
    Review
  16. International consensus statement on allergy and rhinology: Olfaction.International forum of allergy & rhinology · 2022
    Review
  17. Article
  18. Review
  19. Article
  20. A thermoresponsive hydrogel system for long-acting corticosteroid delivery into the paranasal sinuses.Journal of controlled release : official journal of the Controlled Release Society · 2021
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 10 institutions in 2 countries.

Robert C KernNorthwestern University, Chicago, IL.
J Pablo StolovitzkyENT of Georgia, Atlanta, GA.
Stacey L SilversMadison ENT & Facial Plastic Surgery, New York, NY.
Ameet SinghGeorge Washington Medical Faculty Associates, Washington, DC.
Jivianne T LeeOrange County Sinus Institute, Southern California Permanente Medical Group, Irvine, CA.
David M YenBethlehem ENT, Bethlehem, PA.
Alfred M C IloretaMount Sinai Hospital, New York, NY.
Francis P J LangfordCharlotte Eye ENT Associates, Concord, NC.
Boris KaranfilovOhio Sinus Institute, Dublin, OH.
Keith E MathenyCollin County Ear Nose & Throat, Frisco, TX.
James W StambaughIntersect ENT Inc., Menlo Park, CA.
Anna K GawlickaIntersect ENT Inc., Menlo Park, CA.
RESOLVE II study investigators
Intersect ENT (United States) · USOhio Sinus Institute · USBethlehem Area School District · USCharlotte Eye Ear Nose & Throat Associates · USCollin College · USFacial Plastics Surgery Associates · USGeorgia Department of Education · USMount Sinai Hospital · USNorthwestern University · USWashington University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTopical 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.

methodsA 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.

resultsPatients 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).

conclusionSignificant 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.

Indexed as

AdultChronic DiseaseDouble-Blind MethodDrug ImplantsFemaleHumansMaleMiddle AgedMometasone FuroateNasal MucosaNasal PolypsParanasal SinusesPlacebosRecurrenceSinusitisDrug ImplantsMometasone FuroatePlaceboschronic rhinosinusitiscorticosteroid useESSmometasone furoate implantpolyposissinus surgery

Identifiers

PMID29350840
PMCPMC5900893
OpenAlexW2790034004

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.