Original article
Alimentary tract
Swallowed Fluticasone Improves Histologic but Not Symptomatic Response of Adults With Eosinophilic Esophagitis

https://doi.org/10.1016/j.cgh.2012.03.018Get rights and content

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.

Section snippets

Study Design and Study Participants

This was a double-blind, randomized, placebo-controlled trial of fluticasone in a 1:1 allocation ratio in the treatment of EoE. The study was approved by the Mayo Foundation Institutional Review Board. The trial is registered with http://ClinicalTrials.gov, NCT00275561. All subjects provided written informed consent.

Subjects were recruited from the Esophageal Clinic at Mayo Clinic Rochester where they were being seen for a new diagnosis of EoE. They were recruited by the research assistant

Participants

Patient flow is displayed in Figure 1. The patient drop-out rate of 28.6% (6 of 21) in the placebo group was not significantly different from 9.5% (2 of 21) in the treatment group (P = .24). The causes of drop-out were travel in 2 patients, scheduling in 3 patients, family issues in 2 patients, and change of mind on study involvement 1 week after initiation in 1 patient. No patients dropped out for side effects or failure of response to treatment. No patients were excluded from analysis as a

Discussion

This was a double-blind, randomized, placebo-controlled trial of topical aerosolized fluticasone in the treatment of adults with EoE and symptomatic dysphagia. This was a negative study for the primary end point of dysphagia relief despite a strongly positive result for the secondary end point of decreased esophageal eosinophilia.

The complete dysphagia response with fluticasone by ITT (42.9%) or per protocol (PP) (47.4%) was no better than placebo (28.6% and 40.0%, respectively). The PP

References (26)

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    Citation Excerpt :

    The disease predominantly presents in young males with a peak incidence between 20 and 40 years of age but can also occur in females and at any age. Adolescences and adults typically experience intermittent dysphagia and food impactions, which can be related to luminal abnormalities [1]; however, symptoms occur even when the esophagus appears endoscopically normal and a documented histological remission may not lead to the resolution of symptoms [38,56]. From a clinical point of view, a possible explanation for this phenomenon may be the presence of an underlying motor disorder of the esophagus.

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Conflicts of interest This author discloses the following: Jeffrey Alexander is a consultant for Meritage Pharmacia and has stock ownership in Meritage Pharmacia. The remaining authors disclose no conflicts.

Funding This work was supported by an unrestricted grant from the Fitterman Fund for Gastroenterology research.

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