Allergy Immunotherapy in the Management of Eosinophilic Esophagitis (AIMEE)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Clinical, Endoscopic and Histologic Effects of Environmental Allergy Immunotherapy in the Treatment of Eosinophilic Esophagitis|
- Histologic change [ Time Frame: 1 year after after starting allergy immunotherapy ] [ Designated as safety issue: No ]Subjects will be started on allergy immunotherapy. We will compare before and after pathology - changes in eosinophils per high power field in esophageal biopsy.
- Symptomatic changes [ Time Frame: 1 year ] [ Designated as safety issue: No ]Symptom questionaire will be assessed before intervention and after (about 1 year after being on allergy immunotherapy)
- Endoscopic changes [ Time Frame: 1 year ] [ Designated as safety issue: No ]In addition to above, we will score their endoscopic findings before and after the intervention. The categories scored will include: 1. Pallor and diminished vascular markings 2. Furrowing 3. White plaques 4. Concentric rings or strictures. If 1 esophageal site is involved, 1 point will be given. If more than 1 site, 2 points allocated. If entire esophagus is involved, 3 points allocated and maximum score will be 12.
- Eosinophilia change [ Time Frame: 1 year ] [ Designated as safety issue: No ]Absolute eosinophilic counts will be measured before and after intervention.
- Adverse outcomes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Any adverse events will be collected during the first year. Allergy immunotherapy has been used clinically for over 100 years. Local site reactions are common and expected, but we will monitor systemic reaction rates in this specific population and compare to known rates of reactions.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Allergy Immunotherapy Group
There is only one active experimental group as this is a pilot study comparing clinical/histologic/endoscopic changes before and after treatment.
|Biological: Allergy immunotherapy ("allergy shots")|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685034
|Contact: Rachel U Lee, MDfirstname.lastname@example.org|