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

NCT01458418 | Terminated Results

• 1 other identifier: CMH 11 01-007
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophil; Esophagitis

Outcome Measures

Primary Outcomes (1)

• Eosinophil Count

  Eosinophils/high powered field(hpf) in the mid esophagus will be measured after 12 weeks of therapy.

  12 weeks

Study Arms (3)

Montelukast 10 mg/day

EXPERIMENTAL

Subjects will receive two 5mg tablets of Montelukast/day.

Drug: Montelukast

Montelukast 5mg/day

EXPERIMENTAL

Subjects will receive one 5mg tablet of montelukast and 1 placebo tablet per day.

Drug: 5 mg Montelukast

placebo

PLACEBO COMPARATOR

Subjects will receive two placebo tablets per day.

Other: placebo

Interventions

Montelukast DRUG

Those in Montelukast 10mg/day group will receive two 5mg tablets of Montelukast.

Also known as: Singulair

Montelukast 10 mg/day

placebo OTHER

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.

placebo

5 mg Montelukast DRUG

Subject will receive one 5mg tablet of Montelukast and one placebo tablet per day.

Also known as: Singulair

Montelukast 5mg/day

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

Related Publications (17)

• Furuta GT, Liacouras CA, Collins MH, Gupta SK, Justinich C, Putnam PE, Bonis P, Hassall E, Straumann A, Rothenberg ME; First International Gastrointestinal Eosinophil Research Symposium (FIGERS) Subcommittees. Eosinophilic esophagitis in children and adults: a systematic review and consensus recommendations for diagnosis and treatment. Gastroenterology. 2007 Oct;133(4):1342-63. doi: 10.1053/j.gastro.2007.08.017. Epub 2007 Aug 8.

  PMID: 17919504 BACKGROUND

• Rothenberg ME. Biology and treatment of eosinophilic esophagitis. Gastroenterology. 2009 Oct;137(4):1238-49. doi: 10.1053/j.gastro.2009.07.007. Epub 2009 Aug 15.

  PMID: 19596009 BACKGROUND

• Konikoff MR, Noel RJ, Blanchard C, Kirby C, Jameson SC, Buckmeier BK, Akers R, Cohen MB, Collins MH, Assa'ad AH, Aceves SS, Putnam PE, Rothenberg ME. A randomized, double-blind, placebo-controlled trial of fluticasone propionate for pediatric eosinophilic esophagitis. Gastroenterology. 2006 Nov;131(5):1381-91. doi: 10.1053/j.gastro.2006.08.033. Epub 2006 Aug 16.

  PMID: 17101314 BACKGROUND

• Schaefer ET, Fitzgerald JF, Molleston JP, Croffie JM, Pfefferkorn MD, Corkins MR, Lim JD, Steiner SJ, Gupta SK. Comparison of oral prednisone and topical fluticasone in the treatment of eosinophilic esophagitis: a randomized trial in children. Clin Gastroenterol Hepatol. 2008 Feb;6(2):165-73. doi: 10.1016/j.cgh.2007.11.008.

  PMID: 18237866 BACKGROUND

• Dohil R, Newbury R, Fox L, Bastian J, Aceves S. Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial. Gastroenterology. 2010 Aug;139(2):418-29. doi: 10.1053/j.gastro.2010.05.001. Epub 2010 May 7.

  PMID: 20457157 BACKGROUND

• Markowitz JE, Spergel JM, Ruchelli E, Liacouras CA. Elemental diet is an effective treatment for eosinophilic esophagitis in children and adolescents. Am J Gastroenterol. 2003 Apr;98(4):777-82. doi: 10.1111/j.1572-0241.2003.07390.x.

  PMID: 12738455 BACKGROUND

• Assa'ad AH, Putnam PE, Collins MH, Akers RM, Jameson SC, Kirby CL, Buckmeier BK, Bullock JZ, Collier AR, Konikoff MR, Noel RJ, Guajardo JR, Rothenberg ME. Pediatric patients with eosinophilic esophagitis: an 8-year follow-up. J Allergy Clin Immunol. 2007 Mar;119(3):731-8. doi: 10.1016/j.jaci.2006.10.044. Epub 2007 Jan 25.

  PMID: 17258309 BACKGROUND

• Blanchard C, Wang N, Rothenberg ME. Eosinophilic esophagitis: pathogenesis, genetics, and therapy. J Allergy Clin Immunol. 2006 Nov;118(5):1054-9. doi: 10.1016/j.jaci.2006.07.038. Epub 2006 Sep 18.

  PMID: 17088129 BACKGROUND

• Blanchard C, Rothenberg ME. Basic pathogenesis of eosinophilic esophagitis. Gastrointest Endosc Clin N Am. 2008 Jan;18(1):133-43; x. doi: 10.1016/j.giec.2007.09.016.

  PMID: 18061107 BACKGROUND

• Chehade M, Sampson HA, Morotti RA, Magid MS. Esophageal subepithelial fibrosis in children with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2007 Sep;45(3):319-28. doi: 10.1097/MPG.0b013e31806ab384.

  PMID: 17873744 BACKGROUND

• Aceves SS, Ackerman SJ. Relationships between eosinophilic inflammation, tissue remodeling, and fibrosis in eosinophilic esophagitis. Immunol Allergy Clin North Am. 2009 Feb;29(1):197-211, xiii-xiv. doi: 10.1016/j.iac.2008.10.003.

  PMID: 19141355 BACKGROUND

• Wershil BK. Exploring the role of mast cells in eosinophilic esophagitis. Immunol Allergy Clin North Am. 2009 Feb;29(1):189-95, xiii. doi: 10.1016/j.iac.2008.09.006.

  PMID: 19141354 BACKGROUND

• Lucendo AJ, Bellon T, Lucendo B. The role of mast cells in eosinophilic esophagitis. Pediatr Allergy Immunol. 2009 Sep;20(6):512-8. doi: 10.1111/j.1399-3038.2008.00798.x. Epub 2008 Aug 4.

  PMID: 18681944 BACKGROUND

• Attwood SE, Lewis CJ, Bronder CS, Morris CD, Armstrong GR, Whittam J. Eosinophilic oesophagitis: a novel treatment using Montelukast. Gut. 2003 Feb;52(2):181-5. doi: 10.1136/gut.52.2.181.

  PMID: 12524397 BACKGROUND

• El-Swefy S, Hassanen SI. Improvement of hepatic fibrosis by leukotriene inhibition in cholestatic rats. Ann Hepatol. 2009 Jan-Mar;8(1):41-9.

  PMID: 19221533 BACKGROUND

• Izumo T, Kondo M, Nagai A. Cysteinyl-leukotriene 1 receptor antagonist attenuates bleomycin-induced pulmonary fibrosis in mice. Life Sci. 2007 Apr 24;80(20):1882-6. doi: 10.1016/j.lfs.2007.02.038. Epub 2007 Mar 12.

  PMID: 17397875 BACKGROUND

• Montagna NA, de Oliveira ML, Mandarim-de-Lacerda CA, Chimelli L. Leprosy: contribution of mast cells to epineurial collagenization. Clin Neuropathol. 2005 Nov-Dec;24(6):284-90.

  PMID: 16320824 BACKGROUND

MeSH Terms

Conditions

Eosinophilic Esophagitis; Esophagitis

Interventions

montelukast

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

Study was difficult to enroll for and study was stopped due to length of time it took to enroll and sponsor pulling funding prior to enrollment meeting goal to have generalizable data.

Results Point of Contact

• Title: Corey Schurman
• Organization: Children's Mercy Hospital

crschurman@cmh.edu

8162343000

Study Officials

• Stephanie Page, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: October 24, 2011
• Study Start: December 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: October 30, 2020
• Results First Posted: October 30, 2020

Record last verified: 2020-10

Locations

US (1)