title: A randomized, double-blind, placebo-controlled trial of fluticasone propionate for pediatric eosinophilic esophagitis.
abstract: OBJECTIVE
  Eosinophilic esophagitis is an increasingly recognized disorder with distinctive endoscopic, histologic, and allergic features. Although several therapies are advocated, no placebo-controlled trials have been conducted. We aimed to determine the efficacy of swallowed fluticasone propionate (FP) in the treatment of eosinophilic esophagitis.
  
  
  METHODS
  We conducted a randomized, double-blind, placebo-controlled trial of swallowed FP in pediatric patients with active eosinophilic esophagitis. Thirty-six patients were randomly assigned to receive either 880 mug of FP (21 patients) or placebo (15 patients) divided twice daily for 3 months. The primary end point was histologic remission, defined by a peak eosinophil count of </=1 eosinophil in all 400x fields in both the proximal and distal esophagus.
  
  
  RESULTS
  Fifty percent of FP-treated patients achieved histologic remission compared with 9% of patients receiving placebo (P = .047). FP decreased esophageal eosinophil levels, with a more pronounced effect in nonallergic individuals (65.9 +/- 25.3 vs 1.4 +/- 1.1 eosinophils/high-power field in the proximal esophagus [P = .03] and 84.6 +/- 19.7 vs 19.6 +/- 12.9 eosinophils/high-power field in the distal esophagus [P = .04]). Resolution of vomiting occurred more frequently with FP than placebo (67% vs 27%; P = .04). FP-induced resolution of mucosal eosinophilia was associated with resolution of endoscopic findings, epithelial hyperplasia, younger age (P = .0003), shorter height (P = .002), and lighter weight (P = .02). Effective treatment with FP decreased the number of CD8(+) T lymphocytes and mast cells in both the proximal and distal esophagus (P < .05).
  
  
  CONCLUSIONS
  Swallowed FP is effective in inducing histologic remission in eosinophilic esophagitis, with a more pronounced effect in nonallergic and younger individuals, especially in the proximal esophagus.
authors.affiliation: Division of Pediatric Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Konikoff
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Noel
authors.forename: Carine
authors.initials: C
authors.lastname: Blanchard
authors.forename: Cassie
authors.initials: C
authors.lastname: Kirby
authors.forename: Sean C
authors.initials: SC
authors.lastname: Jameson
authors.forename: Bridget K
authors.initials: BK
authors.lastname: Buckmeier
authors.forename: Rachel
authors.initials: R
authors.lastname: Akers
authors.forename: Mitchell B
authors.initials: MB
authors.lastname: Cohen
authors.forename: Margaret H
authors.initials: MH
authors.lastname: Collins
authors.forename: Amal H
authors.initials: AH
authors.lastname: Assa'ad
authors.forename: Seema S
authors.initials: SS
authors.lastname: Aceves
authors.forename: Philip E
authors.initials: PE
authors.lastname: Putnam
authors.forename: Marc E
authors.initials: ME
authors.lastname: Rothenberg
mesh_terms: D000293:Adolescent; D000367:Age Factors; D000730:Androstadienes / Q000627:therapeutic use*; D001827:Body Height; D001835:Body Weight; D018414:CD8-Positive T-Lymphocytes / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004802:Eosinophilia / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology; D004941:Esophagitis / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology; D005260:Female; D000068298:Fluticasone; D006801:Humans; D006965:Hyperplasia; D007223:Infant; D008297:Male
chemical_list: D000730:Androstadienes; D000068298:Fluticasone