Consistency of efficacy, @entity1 acceptability, and nasal tolerability of @entity3575 pectin nasal spray compared with immediate-release XXXX in breakthrough @entity5 .

@entity1 @entity336 @entity5 @entity1286 @entity158 @entity3575
CONTEXT: We recently reported that @entity3575 pectin nasal spray (FPNS) provides superior @entity158 relief from breakthrough @entity5 (BTCP) compared with immediate-release @entity1286 (IRMS), with significant effects by five minutes and clinically meaningful @entity158 relief from 10 minutes postdose. OBJECTIVES: To report the consistency of efficacy, tolerability, and @entity1 acceptability of FPNS vs. IRMS. METHODS: @entity1 (n=110) experiencing one to four BTCP episodes/day while taking >= 60 mg/day oral @entity1286 (or equivalent) for background @entity158 entered a double-blind, double-dummy (DB/ @entity336 ), multiple-crossover study. Those who completed an open-label titration phase (n=84) continued to a DB/ @entity336 phase; 10 episodes were randomly treated with FPNS and overencapsulated placebo or IRMS and nasal spray placebo (five episodes each). @entity158 intensity (PI) and @entity158 relief scores were assessed. @entity1 acceptability scores were assessed at 30 and 60 minutes. Safety and tolerability were assessed by adverse events (AEs) and nasal assessments. RESULTS: Per-episode analysis revealed that FPNS consistently provided relief from @entity158 more rapidly than IRMS; by 10 minutes, there were significant differences in PI difference scores and in the percentages of episodes showing clinically meaningful @entity158 relief (P<0.05). Overall acceptability scores were significantly greater for FPNS than for IRMS at 30 (P<0.01) and 60 (P<0.05) minutes. @entity1 were "satisfied/very satisfied" with the convenience (79.8%) and ease of use (77.2%) of FPNS. Only 4.7% of @entity1 withdrew from titration because of AEs; no significant nasal effects were reported. CONCLUSION: This study demonstrates that FPNS is efficacious, well accepted, and well tolerated by @entity1 with BTCP.
