Clinical–alimentary tractA Randomized, Double-Blind, Placebo-Controlled Trial of Fluticasone Propionate for Pediatric Eosinophilic Esophagitis
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
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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).