EDS-FLU VERSUS TRADITIONAL NASAL STEROIDS FOR TREATING CHRONIC RHINOSINUSITIS: SUMMARIZING CURRENT EVIDENCE FOR SYMPTOM BENEFITS

Abstract

Introduction Standard intranasal steroids (INS) are first-line therapy, but yield limited benefit, in treating defining symptoms of CRSw/sNP (congestion, rhinorrhea, facial pain/pressure, anosmia). We compared symptom relief with traditional INS, as summarized in a 2016 Cochrane review, with symptom relief reported in pooled trials with EDS-FLU (exhalation delivery system with fluticasone). Methods The Cochrane systematic review assessed 18 RCTs of 3-6-month duration in CRSw/sNP (N=2738). EDS-FLU data were from two 24-week (16 double-blind+8 open-label), RCTs (NAVIGATE I/II) in CRSwNP (N=643). Effects on all 4 cardinal symptoms were compared. Results Cochrane data for congestion, rhinorrhea, facial pain/pressure, and sense of smell came from 6, 6, 2, and 4 RCTs, respectively. Facial pain/pressure evidence was deemed low quality; the remainder were moderate quality. Mean difference for INS from placebo (95% CI) was -0.4 (-0.52 to -0.29), -0.25 (-0.33 to -0.17), -0.27 (-0.56 to 0.02), and -0.19 (-0.28 to -0.11) for congestion, rhinorrhea, facial pain/pressure, and sense of smell, respectively. EDS-FLU studies demonstrated a larger mean benefit on all 4 cardinal symptoms (for 186/372µg: congestion -0.46/-0.55, rhinorrhea -0.43/-0.47, facial pain/pressure -0.36/-0.33 and sense of smell -0.25/-0.38). (Table) The magnitude of effect of EDS-FLU 372 mcg on congestion, rhinorrhea and anosmia was higher than the upper 95%CI for other INS reported in the Cochrane review. Pain/pressure benefits were numerically greater, but prior data was low quality and the 95% CI was very wide. Conclusions Current evidence suggests that EDS-FLU produces a larger mean benefit on cardinal symptoms of CRS than standard INS. Standard intranasal steroids (INS) are first-line therapy, but yield limited benefit, in treating defining symptoms of CRSw/sNP (congestion, rhinorrhea, facial pain/pressure, anosmia). We compared symptom relief with traditional INS, as summarized in a 2016 Cochrane review, with symptom relief reported in pooled trials with EDS-FLU (exhalation delivery system with fluticasone). The Cochrane systematic review assessed 18 RCTs of 3-6-month duration in CRSw/sNP (N=2738). EDS-FLU data were from two 24-week (16 double-blind+8 open-label), RCTs (NAVIGATE I/II) in CRSwNP (N=643). Effects on all 4 cardinal symptoms were compared. Cochrane data for congestion, rhinorrhea, facial pain/pressure, and sense of smell came from 6, 6, 2, and 4 RCTs, respectively. Facial pain/pressure evidence was deemed low quality; the remainder were moderate quality. Mean difference for INS from placebo (95% CI) was -0.4 (-0.52 to -0.29), -0.25 (-0.33 to -0.17), -0.27 (-0.56 to 0.02), and -0.19 (-0.28 to -0.11) for congestion, rhinorrhea, facial pain/pressure, and sense of smell, respectively. EDS-FLU studies demonstrated a larger mean benefit on all 4 cardinal symptoms (for 186/372µg: congestion -0.46/-0.55, rhinorrhea -0.43/-0.47, facial pain/pressure -0.36/-0.33 and sense of smell -0.25/-0.38). (Table) The magnitude of effect of EDS-FLU 372 mcg on congestion, rhinorrhea and anosmia was higher than the upper 95%CI for other INS reported in the Cochrane review. Pain/pressure benefits were numerically greater, but prior data was low quality and the 95% CI was very wide. Current evidence suggests that EDS-FLU produces a larger mean benefit on cardinal symptoms of CRS than standard INS.