Oral Viscous Budesonide Is Effective in Children With Eosinophilic Esophagitis in a Randomized, Placebo-Controlled Trial

BACKGROUND & AIMS: Eosinophilic esophagitis (EoE) is caused by immunologic reactions to ingested/inhaled allergens. The diagnosis is considered if >= 15 eosinophils per high-powered field (eos/hpf) are detected in mucosal biopsies. Placebo-controlled studies have not been conducted to evaluate the safety and efficacy of oral viscous budesonide (OVB). METHODS: Children with EoE were randomly assigned to groups that were given OVB (n = 15) or placebo (n = 9). Patients <5 feet and >= 5 feet tall received 1 mg and 2 mg OVB daily, respectively. All patients received lansoprazole. Duration of treatment was 3 months, followed by repeat endoscopy and biopsies. Patients were classified as responders if their peak eosinophil counts were <= 6 eos/hpf, partial responders were 7-19 eos/hpf, and nonresponders were >= 20 eos/hpf. Baseline and post-treatment symptoms and endoscopic and histologic features were scored. RESULTS: Thirteen (86.7%) children given OVB (P < .0001) and none who received placebo (P = .3) were classified as responders. Mean pre-/post-treatment peak eosinophil counts were 66.7 and 4.8 eos/hpf, respectively, in the group given OVB (P < .0001); they were 83.9 and 65.6 eos/hpf, respectively, in the group given placebo (P = .3). In the group given OVB, there were significant reductions from baseline values in proximal (P = .002), mid (P = .0003), and distal (P = .001) esophageal eosinophilia. After OVB therapy, compared with baseline, the mean symptom (P = .0007), endoscopy (P = .0005), and histology scores improved (P = .0035) significantly. CONCLUSIONS: OVB is an effective treatment of pan-esophageal disease in children with EoE. OVB improves symptoms and endoscopic and histologic features. Proton pump inhibitor single therapy did not significantly improve esophageal eosinophilia or symptoms of EoE.