This trial is active, not recruiting.

Conditions eosinophilic esophagitis, dysphagia
Treatments montelukast, fluticasone
Phase phase 3
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
(Active Comparator)
patients will receive 10 mg po montelukast daily for 12 weeks.
montelukast Singulair
montelukast 10mg po pill q day for 12 weeks
(Active Comparator)
patients will receive 440mcg fluticasone po bid for 12 weeks
fluticasone Flovent
fluticasone 440mcg po q bid x 12 weeks

Primary Outcomes

Improvement in Dysphagia symptom score
time frame: 3 month

Secondary Outcomes

Improvement in esophageal histology counts of eosinophils/hpf
time frame: 3 month

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Medical College of Wisconsin.