Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

Medical College of Wisconsin

Status and phase

Withdrawn

Phase 3

Conditions

Dysphagia

Eosinophilic Esophagitis

Treatments

Drug: Montelukast

Drug: Fluticasone

Study type

Interventional

Funder types

Other

Identifiers

NCT01702701

MCWEoEMVF

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.