Allergy Immunotherapy in the Management of Eosinophilic Esophagitis (AIMEE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by United States Naval Medical Center, San Diego
Sponsor:
Information provided by (Responsible Party):
Rachel U Lee, MD, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT01685034
First received: September 5, 2012
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Eosinophilic Esophagitis
Biological: Allergy immunotherapy ("allergy shots")

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, San Diego:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Other Outcome Measures:
  • 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.


Estimated Enrollment: 27
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)
Arms Assigned Interventions
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")

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685034

Contacts
Contact: Rachel U Lee, MD 619-553-8983 rachel.lee@med.navy.mil

Sponsors and Collaborators
United States Naval Medical Center, San Diego
  More Information

Additional Information:
Publications:
Responsible Party: Rachel U Lee, MD, Clinical Investigator, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT01685034     History of Changes
Other Study ID Numbers: NMCSD.2012.0148
Study First Received: September 5, 2012
Last Updated: September 10, 2012
Health Authority: United States: Federal Government

Keywords provided by United States Naval Medical Center, San Diego:
Eosinophilic esophagitis
Environmental allergens
Allergy immunotherapy
Tolerance
Allergic rhinitis
Asthma
Seasonal variation

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014