Clinical trial NCT01685034: Allergy Immunotherapy in the Management of Eosinophilic Esophagitis
Official title: Evaluation of the Clinical, Endoscopic and Histologic Effects of Environmental Allergy Immunotherapy in the Treatment of Eosinophilic Esophagitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophilic esophagitis
Environmental allergens
Allergy immunotherapy
Tolerance
Allergic rhinitis
Asthma
Seasonal variation
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2012-09-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Eosinophilic esophagitis (EoE) is a disease that has increased in incidence over the past decade that affects males predominantly, and in adults, is characterized by heartburn, dysphagia, strictures and food impactions. These symptoms may require emergent endoscopic removal of foods and esophageal dilations due to remodeling causing significant impairment in quality of life. Treatment options are limited and often not well tolerated or effective. There is poor understanding of the natural history and long term prognosis. It has been associated with allergic sensitization; a high percentage of affected individuals having associated atopy and current literature demonstrates a seasonal distribution of incidence and severity of symptoms. Allergy immunotherapy (AIT) is a well established and effective treatment for allergic rhinitis and asthma which can induce tolerance to environmental allergens.

Given the efficacy of AIT and the association of aeroallergen sensitization and even seasonal variation of EoE symptoms, we hypothesized that AIT may be a treatment option for patients with EoE.

Detailed description: Purpose: To evaluate the role of allergy AIT in the management of EoE.

Research design: Patients with EoE and aeroallergen sensitization will be offered AIT as a treatment modality for EoE. They will be evaluated by questionnaire, laboratory tests, endoscopy and biopsy before and after treatment to determine if there is clinical, laboratory, endoscopic and histologic changes in their EoE.

Eligibility criteria: Inclusion Criteria:

* Eligible for care at Naval Medical Center San Diego
* Diagnosis of EoE (with or without GERD)
* Positive skin test to aeroallergen(s)
* Able to provide written informed consent prior to the conduct of any study related procedure

Exclusion Criteria:

* All excluding conditions for Allergy immunotherapy (AIT) - pregnancy, severe asthma, uncontrolled asthma, taking a beta blocker, history of coronary artery disease. (Note: age is not typically an exclusion criteria for AIT, however this will be an adult only study).
* History of significant esophageal disease other than EoE (such as esophageal cancer, surgeries...)
* History of other systemic eosinophilic conditions (such as ...)
* Subjects with controlled asthma on inhaled steroids at the time of diagnosis of EoE may be included , however if a subject develops new asthma or worsening asthma during the study requiring new initiation of inhaled steroids, they may be discontinued to avoid possible swallowing of the medication and "treatment" of their EoE.
* If subject is judged by the investigator as unlikely to understand the scope of the study and/or is unlikely to comply with the study procedures and visits.
* Is currently or has recently been on AIT (within the past year)

Primary outcomes:
measure: Histologic change
timeFrame: 1 year after after starting allergy immunotherapy
Secondary outcomes:
measure: Symptomatic changes
timeFrame: 1 year
Other outcomes:
measure: Endoscopic changes
timeFrame: 1 year
measure: Eosinophilia change
timeFrame: 1 year
measure: Adverse outcomes
timeFrame: 1 year
Locations:
Study officials:
References:
citation: Almansa C, Krishna M, Buchner AM, Ghabril MS, Talley N, DeVault KR, Wolfsen H, Raimondo M, Guarderas JC, Achem SR. Seasonal distribution in newly diagnosed cases of eosinophilic esophagitis in adults. Am J Gastroenterol. 2009 Apr;104(4):828-33. doi: 10.1038/ajg.2008.169. Epub 2009 Feb 24.
citation: Simon D, Marti H, Heer P, Simon HU, Braathen LR, Straumann A. Eosinophilic esophagitis is frequently associated with IgE-mediated allergic airway diseases. J Allergy Clin Immunol. 2005 May;115(5):1090-2. doi: 10.1016/j.jaci.2005.01.017. No abstract available.
citation: Mishra A, Hogan SP, Brandt EB, Rothenberg ME. An etiological role for aeroallergens and eosinophils in experimental esophagitis. J Clin Invest. 2001 Jan;107(1):83-90. doi: 10.1172/JCI10224.
citation: Moawad FJ, Veerappan GR, Lake JM, Maydonovitch CL, Haymore BR, Kosisky SE, Wong RK. Correlation between eosinophilic oesophagitis and aeroallergens. Aliment Pharmacol Ther. 2010 Feb 15;31(4):509-15. doi: 10.1111/j.1365-2036.2009.04199.x. Epub 2009 Nov 19.
citation: Penfield JD, Lang DM, Goldblum JR, Lopez R, Falk GW. The role of allergy evaluation in adults with eosinophilic esophagitis. J Clin Gastroenterol. 2010 Jan;44(1):22-7. doi: 10.1097/MCG.0b013e3181a1bee5.
citation: Onbasi K, Sin AZ, Doganavsargil B, Onder GF, Bor S, Sebik F. Eosinophil infiltration of the oesophageal mucosa in patients with pollen allergy during the season. Clin Exp Allergy. 2005 Nov;35(11):1423-31. doi: 10.1111/j.1365-2222.2005.02351.x.
citation: Fogg MI, Ruchelli E, Spergel JM. Pollen and eosinophilic esophagitis. J Allergy Clin Immunol. 2003 Oct;112(4):796-7. doi: 10.1016/s0091-6749(03)01715-9. No abstract available.