Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

Study Overview
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Brief Summary
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This study will compare response to treatment of Eosinophilic Esophagitis with montelukast vs standard therapy fluticasone. Investigators hypothesize that montelukast is equally effective in treating symptoms and histology of EoE when compared to fluticasone. The study will be conducted at multiple sites with Medical College of Wisconsin as the coordinating site. After identification and recruitment all patients will be randomized (provider blinded) to one of two medications: montelukast 10mg po qday vs fluticasone 440mcg po bid. Patients will also complete a pretreatment, 6 week therapy and 12 week therapy questionaire. They will then undergo a repeat endoscopy to evaluate endoscopic and histologic response.

Detailed Description
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Eosinophilic esophagitis is an allergic condition of the esophagus with an incidence that is on the rise, and has limited treatment options. Current gold standard of treatment is with topical steroids (swallowed fluticasone). There is preliminary data that oral montelukast may prove to be effective in inducing and maintaining symptomatic along with histologic remission of this disease. Investigators will be comparing the effectiveness of singulair to swallowed fluticasone in inducing and maintaining histologic and symptomatic remission of eosinophilic esophagitis.

Official Title
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Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

Conditions
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Eosinophilic Esophagitis, Dysphagia

Intervention / Treatment
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* Drug: Montelukast
* Drug: Fluticasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a confirmed diagnosis of EoE on biopsy with >15 eos per HPF ages >18 Both male and Female. Not pregnant Exclusion Criteria: pregnancy patients receiving ongoing medical therapy for EoE patients who underwent dilation in the last 12 weeks with improvement in symptoms LA grade B or worse erosive esophagitis. age < 18 nursing mothers use of prohibited concomitant medications : budesonide-oral compounded liquid, fluticasone or montelukast.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Montelukast<br>patients will receive 10 mg po montelukast daily for 12 weeks. | Drug: Montelukast<br>* montelukast 10mg po pill q day for 12 weeks<br>* Other names: Singulair;|
| Active Comparator: Fluticasone<br>patients will receive 440mcg fluticasone po bid for 12 weeks | Drug: Fluticasone<br>* fluticasone 440mcg po q bid x 12 weeks<br>* Other names: Flovent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Dysphagia symptom score |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in esophageal histology counts of eosinophils/hpf |  | 3 month |