Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

Withdrawn before enrolling · Phase 3

Conditions studied: Eosinophilic Esophagitis, Dysphagia

In brief

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.

Key facts

Study ID

NCT01702701

Run by

Medical College of Wisconsin

People needed

0

Starts

2012-01-01

Expected to finish

2017-07-20

Last updated by the study team

2019-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients with a confirmed diagnosis of EoE on biopsy
• with >15 eos per HPF
• ages >18
• Both male and Female.
• Not pregnant

You may not qualify if…

• 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.

Where it is running

• GI Associates — Milwaukee, Wisconsin, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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