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A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children

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: NCT01458418
Recruitment Status : Terminated (Inability to complete enrollment due to difficulty in finding subjects)
First Posted : October 24, 2011
Last Update Posted : February 19, 2015
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City

Brief Summary:

Eosinophilic Esophagitis (EE) is a condition where eosinophils (a cell that fights infection) travel to the esophagus (the tube through which food passes to the stomach). These cells do not belong there and can cause pain, soreness, difficulty swallowing and sometimes vomiting.

Ways to treat this condition include medicine, not eating some foods, and drinking a specific formula (like milk) without eating any other foods. Doing these things can help fight off EE but these problems can come back when treatment is stopped. If EE symptoms go on for a long time, it can lead to the esophagus becoming narrow and feeling tight when eating and swallowing and surgery may be needed to widen the narrowed area to relieve the sensation of tightening.

Montelukast is a medicine that fights off a type of chemical that can be a magnet for eosinophils. People usually take this medicine to help treat their asthma. It is not approved to treat EE. This medication is taken once a day.

The purpose of this study is to see if Montelukast, compared to placebo, will help reduce the number of eosinophils in children with EE and help stop the tightening of the esophagus.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: Montelukast Other: placebo Drug: 5 mg Montelukast Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children
Study Start Date : December 2011
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast

Arm Intervention/treatment
Experimental: Montelukast 10 mg/day
Subjects will receive two 5mg tablets of Montelukast/day.
Drug: Montelukast
Those in Montelukast 10mg/day group will receive two 5mg tablets of Montelukast.
Other Name: Singulair

Experimental: Montelukast 5mg/day
Subjects will receive one 5mg tablet of montelukast and 1 placebo tablet per day.
Drug: 5 mg Montelukast
Subject will receive one 5mg tablet of Montelukast and one placebo tablet per day.
Other Name: Singulair

Placebo Comparator: placebo
Subjects will receive two placebo tablets per day.
Other: placebo
Those in the placebo group will receive 2 placebo tablets per day. Those in the Montelukast 5mg/day will receive 1 placebo tablet per day.

Primary Outcome Measures :
  1. Eosinophil count [ Time Frame: 12 weeks ]
    Eosinophils/hpf in the esophagus will be measured after 12 weeks of therapy.

Secondary Outcome Measures :
  1. Amount of MBP, tryptase and trichrome found in esophageal specimens [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males and females aged 2-17
  • Presence of more than 15 eosinophils per hpf on original endoscopy and less than 5 eosinophils/hpf on the most recent endoscopy
  • Concurrent PPI for 1 month at 1-2mg/kg/dose prior to endoscopy or have a negative pH study
  • English speaking
  • Ability to undergo a follow up endoscopy between 12 and 13 weeks after the start of the study
  • Procurement of written informed consent signed by the subject's legal guardian and study investigator (s) and subject assent.

Exclusion Criteria:

  • Subjects with eosinophils in stomach and duodenum on original endoscopy.
  • Subjects requiring oral prednisone within 1 month of current endoscopy.
  • Subjects with diagnosis of other co-morbid diseases such as heart disease, renal disease, autoimmune disease, an immunodeficiency, diabetes, phenylketonuria, or thyroid disease.
  • Subjects using Montelukast within one month of current endoscopy
  • Subjects with concurrent use of phenobarbital or rifampin

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): NCT01458418

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United States, Missouri
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
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Principal Investigator: Stephanie Page, MD Children's Mercy Hospital Kansas City


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Responsible Party: Children's Mercy Hospital Kansas City Identifier: NCT01458418     History of Changes
Other Study ID Numbers: CMH 11 01-007
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: February 19, 2015
Last Verified: February 2015

Keywords provided by Children's Mercy Hospital Kansas City:

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