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Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01702701
First received: October 4, 2012
Last updated: November 21, 2012
Last verified: October 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in esophageal histology counts of eosinophils/hpf [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01702701     History of Changes
Other Study ID Numbers: MCWEoEMVF
Study First Received: October 4, 2012
Last Updated: November 21, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Eosinophilic Esophagitis
Esophagitis
Digestive System Diseases
Eosinophilia
Esophageal Diseases
Gastroenteritis
Gastrointestinal Diseases
Hematologic Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Leukocyte Disorders
Fluticasone
Montelukast
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014