BACKGROUND & AIMS: We evaluated the effect of aerosolized fluticasone therapy on 
symptomatic dysphagia and histologic eosinophilia in adults with eosinophilic 
esophagitis (EoE).
METHODS: We performed a double-blind, randomized, placebo-controlled trial of 
fluticasone in 42 adult patients with a new diagnosis of EoE (30 men; mean age, 
37.5 y). Participants were assigned randomly to groups that swallowed 880 μg of 
aerosolized fluticasone twice daily (n = 21), or took a placebo inhaler twice 
daily (n = 15) for 6 weeks. End points of the study were symptomatic and 
histologic response.
RESULTS: A complete histologic response (>90% decrease in mean eosinophil count) 
was observed in 11 of 15 subjects who received 6 weeks of fluticasone (62%), 
compared with none of the 15 subjects who received placebo (P < .001), based on 
intention-to-treat analysis; histologic responses were observed in 68% of 
subjects who received fluticasone (13 of 19) compared with none of those who 
received placebo (0 of 15) by per-protocol analysis (P < .001). Intracellular 
staining for eosinophil-derived neurotoxin was reduced in 81% of subjects who 
received fluticasone (13 of 16) compared with 8% who received placebo (1 of 13) 
(P < .001). Dysphagia was reduced in 57% of subjects who received fluticasone 
(12 of 21) compared with 33% who received placebo (7 of 21) (P = .22) by 
intention-to-treat analysis; dysphagia was reduced in 63% of patients who 
received fluticasone (12 of 19) and 47% of those who received placebo (7 of 15) 
(P = .49) based on per-protocol analysis. Esophageal candidiasis developed in 
26% of subjects who received fluticasone (5 of 19), but in none of the subjects 
in the placebo group (P = .05).
CONCLUSIONS: Aerosolized, swallowed fluticasone leads to a histologic but not a 
symptomatic response in adults with EoE.