NCT01702701

Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Eosinophilic Esophagitis
• Dysphagia

Interventions

Type	Name	Description
DRUG	Montelukast	montelukast 10mg po pill q day for 12 weeks
DRUG	Fluticasone	fluticasone 440mcg po q bid x 12 weeks

Timeline

• Start date: 2012-01-01
• Primary completion: 2017-07-20
• Completion: 2017-07-20
• First posted: 2012-10-08
• Last updated: 2019-08-28

Locations

2 sites across 1 country: United States