Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01702701
Recruitment Status : Unknown
Verified January 2016 by Medical College of Wisconsin.
Recruitment status was:  Active, not recruiting
First Posted : October 8, 2012
Last Update Posted : January 29, 2016
Information provided by (Responsible Party):
Medical College of Wisconsin

Brief 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.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Dysphagia Drug: Montelukast Drug: Fluticasone Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone
Study Start Date : January 2012
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Arm Intervention/treatment
Active Comparator: Montelukast
patients will receive 10 mg po montelukast daily for 12 weeks.
Drug: Montelukast
montelukast 10mg po pill q day for 12 weeks
Other Name: Singulair

Active Comparator: Fluticasone
patients will receive 440mcg fluticasone po bid for 12 weeks
Drug: Fluticasone
fluticasone 440mcg po q bid x 12 weeks
Other Name: Flovent

Primary Outcome Measures :
  1. Improvement in Dysphagia symptom score [ Time Frame: 3 month ]

Secondary Outcome Measures :
  1. Improvement in esophageal histology counts of eosinophils/hpf [ Time Frame: 3 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01702701

United States, Wisconsin
GI Associates
Milwaukee, Wisconsin, United States, 53226
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Principal Investigator: Walter Hogan, MD Medical College of Wisconsin
Study Director: Nikhil Shastri, MD Medical College of Wisconsin

Responsible Party: Medical College of Wisconsin Identifier: NCT01702701     History of Changes
Other Study ID Numbers: MCWEoEMVF
First Posted: October 8, 2012    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action