Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

• Status: Withdrawn
• Trial end date: 2017-07-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical College of Wisconsin
• Treatments: Fluticasone; Montelukast

Criteria

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.