Allergy Immunotherapy in the Management of Eosinophilic Esophagitis

• Register: ClinicalTrials.gov
• Last refreshed on: 29 August 2016
• Main ID: NCT01685034
• Date of registration: 05/09/2012
• Prospective Registration: Yes
• Primary sponsor: United States Naval Medical Center, San Diego
• Public title: Allergy Immunotherapy in the Management of Eosinophilic Esophagitis AIMEE
• Scientific title: Evaluation of the Clinical, Endoscopic and Histologic Effects of Environmental Allergy Immunotherapy in the Treatment of Eosinophilic Esophagitis
• Date of first enrolment: October 2012
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT01685034
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis

Intervention(s)

Biological: Allergy immunotherapy ("allergy shots")

Primary Outcome(s)

Histologic change [Time Frame: 1 year after after starting allergy immunotherapy]

Secondary Outcome(s)

Symptomatic changes [Time Frame: 1 year]

Secondary ID(s)

NMCSD.2012.0148

Source(s) of Monetary Support

Please refer to primary and secondary sponsors