A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children
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.
|Eosinophilic Esophagitis||Drug: Montelukast Other: placebo Drug: 5 mg Montelukast|
|Study Design:||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|
- Eosinophil count [ Time Frame: 12 weeks ]Eosinophils/hpf in the esophagus will be measured after 12 weeks of therapy.
- Amount of MBP, tryptase and trichrome found in esophageal specimens [ Time Frame: 12 weeks ]
|Study Start Date:||December 2011|
|Study Completion Date:||February 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: Montelukast 10 mg/day
Subjects will receive two 5mg tablets of Montelukast/day.
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.
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01458418
|United States, Missouri|
|Children's Mercy Hospitals and Clinics|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Stephanie Page, MD||Children's Mercy Hospital|