Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

Dysphagia Clinical Trial

Official title:

Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01702701
• Other study ID #: MCWEoEMVF
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 2012
• Est. completion date: July 20, 2017

Study information

• Verified date: January 2016
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 20, 2017
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dysphagia
• Eosinophilic Esophagitis
• Esophagitis

Intervention

Drug:
• Montelukast
montelukast 10mg po pill q day for 12 weeks
• Fluticasone
fluticasone 440mcg po q bid x 12 weeks

Locations

Country	Name	City	State
United States	GI Associates	Milwaukee	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Dysphagia symptom score		3 month
Secondary	Improvement in esophageal histology counts of eosinophils/hpf		3 month