ATLANTA, GA—A Fluticasone Propionate Exhalation Delivery System (EDS-FLU) has demonstrated its superior efficacy by significantly improving various subjective and objective outcomes, including the core symptoms and the polyp grade, of patients diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP), according to findings of the NAVIGATE I study, presented at the 2017 AAAAI Annual Meeting.
A total of 323 patients were enrolled in the 24-week study. Patients included in the analysis were aged at least 18 years and diagnosed with CRSwNP (polyp grade 1–3 in each nasal cavity) and moderate-severe congestion. The first 16 weeks of the trial utilized a double-blind method where patients were randomized to receive either EDS-FLU BID (93µg, 186µg, or 372µg) or placebo EDS. An 8-week, open-label extension period followed where all patients received 372mg of EDS-FLU twice daily.
Primary endpoints included the change in nasal congestion symptoms at week 4 measured by the “Average Diary Score, 7-day, Instantaneous AM (ADS7-IA)” and change in total polyp grade measured at week 16. Two key secondary endpoints of the study included a change in Sino-Nasal Outcome Test-22 (SNOT-22) and Medical Outcomes Study Sleep Scale-Revised (MOS-Sleep-R). Additionally, all core CRS symptoms were evaluated.
Results of the study found that all doses of EDS-FLU produced significant improvement in both primary and secondary endpoints vs. placebo. The authors reported that “at week 4, the least squares (LS) mean change in congestion (ADS7-IA) was -0.49, -0.54, and -0.62, in the 93µg, 186µg, and 372µg groups, respectively, compared with -0.24 in the placebo group” (P<0.01). Data from the study also found improvement in the summed polyp grade in all treatment groups compared to placebo. At week 16, the LS mean change in the summed polyp grade for the 93µg, 186µg, and 372µg treatment groups was -0.96, -1.03, and -1.06, respectively, vs. -0.45 for placebo (P<0.01). The authors concluded that for the primary endpoints tested, “higher doses of EDS-FLU (186µg and 372µg) produced faster onset of action and numerically larger improvement in congestion and polyp grade than the lowest dose (93µg).”
Data from the study also found that “almost twice the proportion” of patients receiving EDS-FLU reported improvement in their symptoms compared to patients receiving placebo (P<0.005). All EDS-FLU groups showed significant improvement in SNOT-22 scores as well as core nasal symptoms compared to placebo. The authors also noted that “multiple measures of QoL were statistically superior in all EDS-FLU groups vs. placebo.” Additionally, it was found that treatment with EDS-FLU reduced surgical eligibility by approximately 60%.
The NAVIGATE I study demonstrated the superior efficacy of EDS-FLU compared to placebo. “FLU-EDS doses of 93µg, 186µg, and 372µg twice daily significantly reduced coprimary endpoints of nasal congestion/obstruction, total polyp grade, and SNOT-22,” concluded lead study author Daniel Soteres, MD, of Asthma and Allergy Associates in Colorado Springs, CO.