Evidence map›Paper›PMID 35674488›Full record

ArticleInternational forum of allergy & rhinology2023

Efficacy of the exhalation delivery system with fluticasone in patients with chronic rhinosinusitis with nasal polyps whose symptoms recur after sinus surgery.

Randall A Ow, Zachary M Soler, Raj Sindwani, Donald A Leopold, Jivianne T Lee, Ramy A Mahmoud, Joseph K Han

Open access · greenAbstract read
In one paragraph

Article in International forum of allergy & rhinology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.8field-weighted citation impact, top 9% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Sleep in disease: inflammation and chronic rhinosinusitis.Neurobiology of sleep and circadian rhythms · 2025
    Article
  5. Article
  6. Article
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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

7 authors at 7 institutions in 1 country.

Randall A OwSacramento Ear Nose Throat, Roseville, California, USA.
Zachary M SolerDepartment of Otolaryngology - Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina, USA.
Raj SindwaniHead and Neck Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Donald A LeopoldDepartment of Surgery, College of Medicine, University of Vermont, Burlington, Vermont, USA.
Jivianne T LeeDepartment of Head and Neck Surgery, UCLA David Geffen School of Medicine, Los Angeles, California, USA.
Ramy A MahmoudOptiNose US, Inc., Yardley, Pennsylvania, USA.
Joseph K HanDepartment of Otolaryngology Head and Neck Surgery, Eastern Virginia Medical School, Norfolk, Virginia, USA.
Carolina Ear, Nose and Throat Clinic · USCleveland Clinic · USEastern Virginia Medical School · USMedical University of South Carolina · USOptiNose (United States) · USUniversity of California, Los Angeles · USUniversity of Vermont · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSinus surgery removes inflamed tissue, restores airflow, and improves delivery of medication into surgically opened spaces. The exhalation delivery system with fluticasone (EDS-FLU; XHANCE

objectiveWe aimed to compare EDS-FLU treatment responses in patients with recurrent symptoms after endoscopic sinus surgery (ESS) and patients who have never had sinus surgery.

methodsData were pooled from two large, controlled trials (NAVIGATE I and II) for exploratory analyses. Chronic rhinosinusitis symptoms, polyp grade, and quality-of-life measures were compared between patients with prior ESS and those without prior ESS.

resultsPatients with prior ESS (exhalation delivery system-placebo [n = 53], EDS-FLU 186 μg [n = 52], and EDS-FLU 372 μg [n = 49]) and unoperated patients (exhalation delivery system-placebo [n = 108], EDS-FLU 186 μg [n = 108], and EDS-FLU 372 μg [n = 111]) treated with EDS-FLU reported similar and substantial benefits as measured by multiple symptom and quality-of-life/functioning outcomes (congestion score, 22-Item Sinonasal Outcomes Test [SNOT-22], Rhinosinusitis Disability Index [RSDI], Patient Global Impression of Change) and by nasal polyp grade. In previously operated patients, unlike surgery-naive patients, multiple outcomes (SNOT-22, RSDI, polyp grade) consistently showed numerically but not statistically greater responses to the higher dose.

conclusionsPatients with recurrent symptoms after sinus surgery who were treated with EDS-FLU demonstrated significant symptom and quality-of-life improvement. Unlike unoperated patients, patients with prior ESS had a numerically but not statistically greater response to the higher dose of EDS-FLU (two sprays per nostril twice a day).

Indexed as

Nasal PolypsRhinitisSinusitisChronic DiseaseEndoscopyExhalationFluticasoneHumansRandomized Controlled Trials as TopicTreatment OutcomeFluticasonechronic rhinosinusitiscorticosteroid useendoscopic sinus surgerypatient-reported outcome measuresquality of lifeSNOT-22topical therapy for chronic rhinosinusitis

Identifiers

PMID35674488
PMCPMC10084243
OpenAlexW4282918594

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

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.