A Phase 3 interventional study of Montelukast and Fluticasone in Eosinophilic Esophagitis and Dysphagia, sponsored by Medical College of Wisconsin. Withdrawn at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by Medical College of Wisconsin · Phase 3, Interventional, and Treatment
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.
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.
322 studies on the registry are indexed under Esophagitis; 37 are open to participants now.
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Exclusion Criteria:
patients will receive 10 mg po montelukast daily for 12 weeks.
Drug: Montelukast
patients will receive 440mcg fluticasone po bid for 12 weeks
Drug: Fluticasone
montelukast 10mg po pill q day for 12 weeks
Also known as: Singulair
fluticasone 440mcg po q bid x 12 weeks
Also known as: Flovent
Improvement in Dysphagia symptom score
Time frame: 3 month
Improvement in esophageal histology counts of eosinophils/hpf
Time frame: 3 month
This study is withdrawn, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Medical College of Wisconsin