ArticleInternational forum of allergy & rhinology2018
EXHANCE-12: 1-year study of the exhalation delivery system with fluticasone (EDS-FLU) in chronic rhinosinusitis.
Article 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 NCT07270302 (Safety and Efficacy of Nebulized Nasal Steroids for the Treatment of Chronic Rhinosinusitis), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Safety and Efficacy of Nebulized Nasal Steroids for the Treatment of Chronic Rhinosinusitis
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 53 citations in OpenAlex.
- Effectiveness of the exhalation delivery system with fluticasone for treating chronic rhinosinusitis with nasal polyposis: a systematic review and meta-analysis.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 · 2025Pooled it
- EDS-FLU efficacy in patients with chronic rhinosinusitis with or without prior sinus surgery in ReOpen1 and ReOpen2 randomized controlled trials.International forum of allergy & rhinology · 2024Trial
- NAVIGATE I: Randomized, Placebo-Controlled, Double-Blind Trial of the Exhalation Delivery System With Fluticasone for Chronic Rhinosinusitis With Nasal Polyps.American journal of rhinology & allergy · 2019Trial
- Intranasal drug delivery: Unlocking the nose-to-brain route for central nervous system therapies.International journal of pharmaceutics: X · 2026Review
- Sleep in disease: inflammation and chronic rhinosinusitis.Neurobiology of sleep and circadian rhythms · 2025Article
- Review
- Comparative study of nasal cavity drug delivery efficiency with different nozzles in a 3D printed model.PeerJ · 2024Article
- Bi-directional nasal drug delivery systems: A scoping review of nasal particle deposition patterns and clinical application.Laryngoscope investigative otolaryngology · 2023Article
- Considerations for shared decision-making in treatment of chronic rhinosinusitis with nasal polyps.Frontiers in allergy · 2023Review
- Efficacy of the exhalation delivery system with fluticasone in patients with chronic rhinosinusitis with nasal polyps whose symptoms recur after sinus surgery.International forum of allergy & rhinology · 2023Article
- In Vitro Evaluation of Nasal Aerosol Depositions: An Insight for Direct Nose to Brain Drug Delivery.Pharmaceutics · 2021Review
- Canadian Rhinology Working Group consensus statement: biologic therapies for chronic rhinosinusitis.Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale · 2021Article
- Medical devices in allergy practice.The World Allergy Organization journal · 2020Review
- Antibiotic eluting sinus stents.Laryngoscope investigative otolaryngology · 2020Review
- Current and Future Treatments of Rhinitis and Sinusitis.The journal of allergy and clinical immunology. In practice · 2020Review
- Exhalation Delivery System: Novel Device for Nasal Polyps Treatment.Pediatric allergy, immunology, and pulmonology · 2019Article
- EXHANCE-12: 1-year study of the exhalation delivery system with fluticasone (EDS-FLU) in chronic rhinosinusitis.International forum of allergy & rhinology · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInadequate efficacy of current intranasal steroids in chronic rhinosinusitis (CRS) is attributable to ineffective and/or inconsistent drug delivery to target anatomic sites. A new exhalation delivery system with fluticasone (EDS-FLU) may improve outcomes by significantly increasing superior/posterior corticosteroid delivery. A study was conducted to assess the long-term efficacy and safety outcomes of EDS-FLU in individuals with CRS.
methodsThis was a 12-month, multicenter, single-arm study evaluating the safety and efficacy of EDS-FLU 372 μg twice daily in CRS patients (with [n = 34] or without [n = 189] nasal polyps [NP]). Efficacy assessments by serial nasal endoscopy and patient report included: 22-item Sino-Nasal Outcome Test (SNOT-22), NP grade, standardized surgical indicator assessment, Lund-Kennedy score, and Patient Global Impression of Change. Adverse event (AE) evaluations included nasal endoscopy. Additional safety and efficacy outcomes were assessed.
resultsOf 223 patients who received EDS-FLU, 96% reported prior corticosteroid use and 29% prior sinus surgery. The EDS-FLU AE profile was similar to conventional intranasal steroids studied in similar populations. Most patients (87%) reported symptom improvement. Through 12 months, mean SNOT-22 scores improved by -21.5 and -21.1 for CRS with and without NP, respectively. Among patients with NP, 54.2% had polyp elimination in at least 1 nostril and 83.3% had ≥1-point improvement in polyp grade.
conclusionOver 1 year of treatment in CRS with and without NP, EDS-FLU 372 μg twice daily was well tolerated and produced improvements across a broad range of objective and subjective measures. EDS-FLU may be a desirable new option for patients with this condition.
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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.