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Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01702701
First Posted: October 8, 2012
Last Update Posted: January 29, 2016
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.
Information provided by (Responsible Party):
Medical College of Wisconsin
  Purpose
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 Intervention Phase
Eosinophilic Esophagitis Dysphagia Drug: Montelukast Drug: Fluticasone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

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

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

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01702701


Locations
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
Investigators
Principal Investigator: Walter Hogan, MD Medical College of Wisconsin
Study Director: Nikhil Shastri, MD Medical College of Wisconsin
  More Information

Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01702701     History of Changes
Other Study ID Numbers: MCWEoEMVF
First Submitted: October 4, 2012
First Posted: October 8, 2012
Last Update Posted: January 29, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Montelukast
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