Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: July 20, 2017

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.

Interventions

  • Drug: Montelukast
    • montelukast 10mg po pill q day for 12 weeks
  • Drug: Fluticasone
    • fluticasone 440mcg po q bid x 12 weeks

Arms, Groups and Cohorts

  • Active Comparator: Montelukast
    • patients will receive 10 mg po montelukast daily for 12 weeks.
  • Active Comparator: Fluticasone
    • patients will receive 440mcg fluticasone po bid for 12 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Improvement in Dysphagia symptom score
    • Time Frame: 3 month

Secondary Measures

  • Improvement in esophageal histology counts of eosinophils/hpf
    • Time Frame: 3 month

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Medical College of Wisconsin
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Walter Hogan, MD, Principal Investigator, Medical College of Wisconsin
    • Nikhil Shastri, MD, Study Director, Medical College of Wisconsin

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