Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone
This trial is active, not recruiting.
|Conditions||eosinophilic esophagitis, dysphagia|
|Sponsor||Medical College of Wisconsin|
|Start date||January 2012|
|End date||August 2016|
|Trial size||100 participants|
|Trial identifier||NCT01702701, MCWEoEMVF|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
Improvement in Dysphagia symptom score
time frame: 3 month
Improvement in esophageal histology counts of eosinophils/hpf
time frame: 3 month
Male or female participants at least 18 years old.
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.
|Official title||Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone|
|Principal investigator||Walter Hogan, MD|
|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.|
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