NAVIGATE II: randomized, double-blind trial of the exhalation delivery system with fluticasone (EDS-FLU) for nasal polyposis

Publication date: Available online 19 June 2018
Source:Journal of Allergy and Clinical Immunology
Author(s): Donald A. Leopold, David Elkayam, John C. Messina, Colette Kosik-Gonzalez, Per G. Djupesland, Ramy A. Mahmoud
BackgroundChronic rhinosinusitis (CRS) is common and sometimes complicated by nasal polyps (NP). Corticosteroid nasal sprays are often unsatisfactory because they are ineffective at delivering medication to high/deep sites of inflammation.ObjectiveAssess whether an exhalation delivery system with fluticasone (EDS-FLU), capable of high/deep drug deposition, improves outcomes.MethodsPatients (N=323) ≥18 years with moderate-to-severe congestion and NP were randomized to twice-daily EDS-FLU (93, 186, or 372μg) or EDS-placebo for 24 weeks (16 double-blind [DB] plus 8 open-label [OL] when all received 372μg). Coprimary endpoints were change in nasal congestion/obstruction at 4 weeks and summed bilateral polyp grade at 16 weeks. Secondary endpoints included symptoms, polyp elimination, and functioning.ResultsEDS-FLU was superior on both co-primary endpoints (P < .001 vs EDS-placebo, all doses). Mean polyp grade improved continuously through week 24 (P < .009, all comparisons), with polyps eliminated on at least 1 side in ∼25% of patients at week 24 vs 8.7% with EDS-placebo (P≤0.014, all comparisons). Sino-nasal Outcomes Test (SNOT-22) scores also improved significantly versus EDS-placebo (-21.1 to -21.4 vs. -11.7 at week 16; P<0.05 all doses). At the end of DB, EDS-FLU (all doses) significantly improved all 4 defining disease symptoms. Most EDS-FLU patients (68%) reported "much" or "very much" improvement. The number of patients eligible for surgery decreased 62%-67%. The safety profile was similar to that reported in prior trials evaluating conventional corticosteroid nasal sprays in comparable populations.ConclusionEDS-FLU produces clinically and statistically significant improvement in all 4 diagnostically defining disease symptoms, polyp grade, and quality of life in CRSwNP.

Teaser

NAVIGATE II shows that EDS-FLU substantially improves multiple objective and subjective outcomes in CRSwNP, including all four diagnostically defining symptoms and multiple quality of life measures, reduces polyp grade, and eliminates polyps in some patients.


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