title: Swallowed fluticasone improves histologic but not symptomatic response of adults with eosinophilic esophagitis.
abstract: OBJECTIVE
  We evaluated the effect of aerosolized fluticasone therapy on symptomatic dysphagia and histologic eosinophilia in adults with eosinophilic esophagitis (EoE).
  
  
  METHODS
  We performed a double-blind, randomized, placebo-controlled trial of fluticasone in 42 adult patients with a new diagnosis of EoE (30 men; mean age, 37.5 y). Participants were assigned randomly to groups that swallowed 880 μg of aerosolized fluticasone twice daily (n = 21), or took a placebo inhaler twice daily (n = 15) for 6 weeks. End points of the study were symptomatic and histologic response.
  
  
  RESULTS
  A complete histologic response (>90% decrease in mean eosinophil count) was observed in 11 of 15 subjects who received 6 weeks of fluticasone (62%), compared with none of the 15 subjects who received placebo (P < .001), based on intention-to-treat analysis; histologic responses were observed in 68% of subjects who received fluticasone (13 of 19) compared with none of those who received placebo (0 of 15) by per-protocol analysis (P < .001). Intracellular staining for eosinophil-derived neurotoxin was reduced in 81% of subjects who received fluticasone (13 of 16) compared with 8% who received placebo (1 of 13) (P < .001). Dysphagia was reduced in 57% of subjects who received fluticasone (12 of 21) compared with 33% who received placebo (7 of 21) (P = .22) by intention-to-treat analysis; dysphagia was reduced in 63% of patients who received fluticasone (12 of 19) and 47% of those who received placebo (7 of 15) (P = .49) based on per-protocol analysis. Esophageal candidiasis developed in 26% of subjects who received fluticasone (5 of 19), but in none of the subjects in the placebo group (P = .05).
  
  
  CONCLUSIONS
  Aerosolized, swallowed fluticasone leads to a histologic but not a symptomatic response in adults with EoE.
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, MN 55905, USA. alexander.jeffrey14@mayo.edu
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Alexander
authors.forename: Kee Wook
authors.initials: KW
authors.lastname: Jung
authors.forename: Amindra S
authors.initials: AS
authors.lastname: Arora
authors.forename: Felicity
authors.initials: F
authors.lastname: Enders
authors.forename: David A
authors.initials: DA
authors.lastname: Katzka
authors.forename: Gail M
authors.initials: GM
authors.lastname: Kephardt
authors.forename: Hirohito
authors.initials: H
authors.lastname: Kita
authors.forename: Lori A
authors.initials: LA
authors.lastname: Kryzer
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Romero
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Smyrk
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Talley
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000336:Aerosols / Q000008:administration & dosage*; D000368:Aged; D000730:Androstadienes / Q000008:administration & dosage*; D018926:Anti-Allergic Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D057765:Eosinophilic Esophagitis / Q000188:drug therapy* / Q000473:pathology*; D005260:Female; D000068298:Fluticasone; D006651:Histocytochemistry; D006801:Humans; D008297:Male; D008856:Microscopy, Fluorescence; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000336:Aerosols; D000730:Androstadienes; D018926:Anti-Allergic Agents; D010919:Placebos; D000068298:Fluticasone