Trial reportAmerican journal of rhinology & allergy2019
NAVIGATE I: Randomized, Placebo-Controlled, Double-Blind Trial of the Exhalation Delivery System With Fluticasone for Chronic Rhinosinusitis With Nasal Polyps.
Trial report in American journal of rhinology & allergy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 80 citations in OpenAlex.
- Effect of glucocorticoids on smell sensation in patients with non-traumatic olfactory disorders: a systematic review and meta-analysis.European journal of clinical pharmacology · 2026Pooled it
- 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
- Efficacy and Safety of Sea Salt-Derived Physiological Saline Nasal Spray as Add-On Therapy in Patients with Acute Upper Respiratory Infection: A Multicenter Retrospective Cohort Study.Medical science monitor : international medical journal of experimental and clinical research · 2021Trial
- Exhalation delivery system with fluticasone improves quality of life and health status: pooled analysis of phase 3 trials NAVIGATE I and II.International forum of allergy & rhinology · 2020Trial
- Cost Utility Analysis of Fluticasone Exhalation Delivery System Versus Budesonide Nasal Irrigation for Chronic Rhinosinusitis With Nasal Polyps.International forum of allergy & rhinology · 2026Article
- Intranasal drug delivery: Unlocking the nose-to-brain route for central nervous system therapies.International journal of pharmaceutics: X · 2026Review
- Preliminary Clinical Outcomes of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in Chronic Rhinosinusitis With Nasal Polyps: A Case Report.Journal of cellular and molecular medicine · 2026Article
- Importance of Smell Loss to Patients With Chronic Rhinosinusitis With Nasal Polyps: Options for Management and Recovery.Clinical and translational allergy · 2026Review
- Acute Exacerbations of Chronic Rhinosinusitis.Current allergy and asthma reports · 2025Review
- Effects of Nozzle Retraction Elimination on Spray Distribution in Middle-Posterior Turbinate Regions: A Comparative Study.Pharmaceutics · 2024Article
- Review
- Bi-directional nasal drug delivery systems: A scoping review of nasal particle deposition patterns and clinical application.Laryngoscope investigative otolaryngology · 2023Article
- New Developments in Allergic Fungal Rhinosinusitis Pathophysiology and Treatment.American journal of rhinology & allergy · 2023Review
- Understanding the CRSwNP Patient as Whole.American journal of rhinology & allergy · 2023Review
- 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
- Pathogenesis and treatment of chronic rhinosinusitis from the perspective of sinonasal epithelial dysfunction.Frontiers in medicine · 2023Review
- Pharmacology, particle deposition and drug administration techniques of intranasal corticosteroids for treating allergic rhinitis.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2022Review
- International consensus statement on allergy and rhinology: Olfaction.International forum of allergy & rhinology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundChronic rhinosinusitis is a common, high-morbidity chronic inflammatory disease, and patients often experience suboptimal outcomes with current medical treatment. The exhalation delivery system with fluticasone (EDS-FLU) may improve care by increasing superior/posterior intranasal corticosteroid deposition.
objectiveTo evaluate the efficacy and safety of EDS-FLU versus EDS-placebo in patients with nasal polyps (NP). Coprimary end points were change in nasal congestion and polyp grade. Key secondary end points were Sino-Nasal Outcome Test-22 (SNOT-22) and Medical Outcomes Study Sleep Scale-Revised (MOS Sleep-R). Other prespecified end points included all 4 cardinal symptoms of NP, 36-Item Short Form Health Survey (SF-36), Patient Global Impression of Change (PGIC), Rhinosinusitis Disability Index (RSDI), and key indicators for surgical intervention.
designRandomized, double-blind, EDS-placebo-controlled, multicenter study.
methodsThree hundred twenty-three subjects with NP and moderate-severe congestion/obstruction, most with history of corticosteroid use (94.4%) and/or prior surgery (60.4%), were randomized to EDS-FLU 93 µg, 186 µg, or 372 µg or EDS-placebo twice daily (BID) for 24 weeks (16 double-blind + 8 single-arm extension with EDS-FLU 372 µg BID).
resultsAll EDS-FLU doses produced significant improvement in both coprimary end points ( P < .05) and in SNOT-22 total score ( P ≤ .005). EDS-FLU significantly improved all 4 cardinal symptoms of NP ( P < .05), including congestion/obstruction, facial pain/pressure, rhinorrhea/post-nasal drip, and hyposmia/anosmia. Approximately 80% of subjects reported improvement with EDS-FLU, with 65% reporting "much" or "very much" improvement by week 16. Adverse events were generally local in nature and similar to other intranasal steroids studied for similar durations in similar populations, with the most common being epistaxis.
conclusionsIn patients with chronic rhinosinusitis with NP (CRSwNP) who were symptomatic despite high rates of prior intranasal steroid use and/or surgery, EDS-FLU produced statistically significant and clinically meaningful improvements compared to EDS-placebo in multiple subjective and objective outcomes (symptoms, SNOT-22, RSDI, SF-36, PGIC, and NP grade), including all 4 cardinal symptoms of CRSwNP.
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