BACKGROUND & AIMS: Topical corticosteroids are effective in inducing clinical 
and histologic remission in patients with eosinophilic esophagitis (EoE). 
However, the best long-term management strategy for this chronic inflammatory 
disease has not been determined.
METHODS: In a randomized, double-blind, placebo-controlled, 50-week trial, we 
evaluated in 28 patients the efficacy of twice-daily swallowed budesonide (0.25 
mg each) to maintain quiescent EoE in remission. Pretreatment and posttreatment 
activity was assessed clinically, endoscopically, histologically, 
immunohistologically, and by endosonography. The primary end point was the 
therapy's ability to maintain EoE in histologic remission. Secondary end points 
were efficacy in symptom control, prevention of tissue remodeling, and safety.
RESULTS: In patients given low-dose budesonide, the load of esophageal 
eosinophils increased from 0.4 to 31.8 eosinophils/high-power field (P = .017). 
In patients given placebo, the load increased from 0.7 to 65.0 
eosinophils/high-power field (P = .0001); this increase was significantly 
greater than in patients given budesonide (P = .024). The symptom scores 
developed in a similar manner in the 2 groups. Budesonide, but not placebo, 
reduced noneosinophilic markers of inflammation, epithelial cell apoptosis, and 
remodeling events. Compared with control individuals, patients had significantly 
thickened esophageal walls, based on endosonography (3.05 vs 2.18 mm; P < 
.0001). Budesonide therapy was associated with a significant reduction in 
mucosal thickness (0.75-0.45 mm; P = .025), but epithelial thickness remained 
stable (261.22 vs 277.23 μm; P = .576). No serious adverse events occurred.
CONCLUSIONS: Low-dose budesonide is more effective than placebo in maintaining 
EoE in histologic and clinical remission. Signs of esophageal remodeling showed 
a trend toward normalization. Long-term administration of topical 
corticosteroids was well tolerated without induction of epithelial atrophy.