Gastroenterology

Gastroenterology

Volume 131, Issue 5, November 2006, Pages 1381-1391
Gastroenterology

Clinical–alimentary tract
A Randomized, Double-Blind, Placebo-Controlled Trial of Fluticasone Propionate for Pediatric Eosinophilic Esophagitis

https://doi.org/10.1053/j.gastro.2006.08.033Get rights and content

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-controlled trial of swallowed FP in pediatric patients with active eosinophilic esophagitis. Thirty-six patients were randomly assigned to receive either 880 μg 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 400× 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.

Section snippets

Selection of Patients

The study was performed between January 10, 2003, and August 16, 2005, at Cincinnati Children’s Hospital Medical Center. Two patients were also enrolled at Children’s Hospital, San Diego. Eligible patients were between the ages of 3 and 30 years with a diagnosis of EE confirmed histologically. Specifically, EE was defined as the presence of ≥24 eosinophils in any 400× HPF in at least one biopsy specimen from either the proximal or distal esophagus and the presence of epithelial hyperplasia

Patient Characteristics

Ninety-two patients were screened for the study; 56 were excluded, and 36 were randomized (Figure 1). Of the 56 excluded patients, 21 did not meet entry criteria and 35 refused to participate in the placebo-controlled study. Of the 36 randomized patients, 21 received FP and 15 received placebo. Thirty-one patients completed the study. One patient was excluded from the FP group after randomization, because this patient did not meet the inclusion criteria for the diagnosis of EE. Four patients

Discussion

This study showed that swallowed FP induces remission in EE, with histologic resolution noted in approximately 50% of patients. FP treatment trended toward greater efficacy in the proximal esophagus, as more patients achieved a complete or partial response in this location than in the distal esophagus. Of note, nearly 50% of patients in the placebo group also had at least a partial response in the proximal esophagus, perhaps indicating that the proximal esophagus is less severely affected by EE

References (33)

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Supported by the Burroughs Wellcome Fund, the CURED Foundation, the Buckeye Foundation, an American Academy of Allergy Asthma & Immunology/Sanofi-Aventis Women Physician in Allergy grant, and a grant from the US Public Health Service (NIH T32 DK007727).

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