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Efficacy of the exhalation delivery system with fluticasone in patients who remain symptomatic on standard nasal steroid sprays
Author(s) -
Senior Brent A.,
Schlosser Rodney J.,
Bosso John,
Soler Zachary M.
Publication year - 2021
Publication title -
international forum of allergy and rhinology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.503
H-Index - 46
eISSN - 2042-6984
pISSN - 2042-6976
DOI - 10.1002/alr.22693
Subject(s) - medicine , nasal congestion , rhinorrhea , fluticasone , exhalation , fluticasone propionate , placebo , nasal spray , population , gold standard (test) , nose , anesthesia , surgery , corticosteroid , nasal administration , pharmacology , pathology , alternative medicine , environmental health
Background Standard nasal steroid sprays are often first‐line treatment for chronic rhinosinusitis (CRS), but many patients remain symptomatic despite their use. The exhalation delivery system with fluticasone (EDS‐FLU) has been shown to be efficacious in mixed populations of symptomatic patients, but the question remains whether benefits would be similar in those already on traditional steroid sprays. The goal of this study was to compare EDS‐FLU treatment outcomes in patients who have previously failed nasal steroids. Methods Using pooled data from the NAVIGATE I and II trials, EDS‐FLU efficacy was compared in the subgroup treated with a conventional nasal steroid at trial entry (mean duration, ≈3 years) to efficacy in the overall study population. Sensitivity analyses were performed for more restrictive definitions of the subgroup changing from prior standard nasal steroids. Results Of 482 total subjects, 218 (45.2%) reported using standard nasal steroid sprays at entry (mean duration, 1051 days). Across multiple outcome measures, improvements for “switchers” receiving EDS‐FLU (least squares mean change from baseline vs EDS plus placebo) were comparable with improvements in the overall population. For EDS‐FLU 372 μg, comparable improvements were observed in congestion (−0.73 vs −0.62), rhinorrhea (−0.71 vs −0.57), facial pain/pressure (−0.48 vs −0.41), and sense of smell (−0.35 vs −0.30) at week 4 and 22‐item Sino‐Nasal Outcome Test (−21.01 vs −20.52), Patient Global Impression of Change, and other outcomes at week 16. Results for EDS‐FLU 186 μg were similar. Conclusion EDS‐FLU comparably improves symptoms, irrespective of whether patients are symptomatic while using conventional nasal steroids before treatment.