A randomized, double-blind, placebo-controlled trial of fluticasone propionate for pediatric eosinophilic esophagitis.
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.
Konikoff
Michael R
MR
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
Noel
Richard J
RJ
Blanchard
Carine
C
Kirby
Cassie
C
Jameson
Sean C
SC
Buckmeier
Bridget K
BK
Akers
Rachel
R
Cohen
Mitchell B
MB
Collins
Margaret H
MH
Assa'ad
Amal H
AH
Aceves
Seema S
SS
Putnam
Philip E
PE
Rothenberg
Marc E
ME
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
D000730:Androstadienes; D000068298:Fluticasone