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Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

Information source: Medical College of Wisconsin
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Eosinophilic Esophagitis; Dysphagia

Intervention: Montelukast (Drug); Fluticasone (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Medical College of Wisconsin

Official(s) and/or principal investigator(s):
Walter Hogan, MD, Principal Investigator, Affiliation: Medical College of Wisconsin
Nikhil Shastri, MD, Study Director, Affiliation: Medical College of Wisconsin


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.

Clinical Details

Official title: Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Improvement in Dysphagia symptom score

Secondary outcome: Improvement in esophageal histology counts of eosinophils/hpf

Detailed description: 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

GI Associates, Milwaukee, Wisconsin 53226, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: January 2012
Last updated: August 5, 2015

Page last updated: August 23, 2015

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