A randomized, double-blind, placebo-controlled trial of fluticasone propionate for pediatric eosinophilic esophagitis

Background & Aims: 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-con trolled trial of swallowed FP in pediatric patients with active eosinophilic esophagitis. Thirty-six patients were randomly assigned to receive either 880 mu g 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.