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Allergy Immunotherapy in the Management of Eosinophilic Esophagitis (AIMEE)

Primary Purpose

Eosinophilic Esophagitis

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Allergy immunotherapy ("allergy shots")

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring Eosinophilic esophagitis, Environmental allergens, Allergy immunotherapy, Tolerance, Allergic rhinitis, Asthma, Seasonal variation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Allergy Immunotherapy Group

Arm Description

There is only one active experimental group as this is a pilot study comparing clinical/histologic/endoscopic changes before and after treatment.

Outcomes

Primary Outcome Measures

Histologic change

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

Symptom questionaire will be assessed before intervention and after (about 1 year after being on allergy immunotherapy)

Full Information

NCT ID

NCT01685034

First Posted

September 5, 2012

Last Updated

August 17, 2016

Sponsor

United States Naval Medical Center, San Diego

1. Study Identification

Unique Protocol Identification Number

NCT01685034

Brief Title

Allergy Immunotherapy in the Management of Eosinophilic Esophagitis

Acronym

AIMEE

Official Title

Evaluation of the Clinical, Endoscopic and Histologic Effects of Environmental Allergy Immunotherapy in the Treatment of Eosinophilic Esophagitis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Researcher deployed before approval

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

United States Naval Medical Center, San Diego

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eosinophilic Esophagitis

Keywords

Eosinophilic esophagitis, Environmental allergens, Allergy immunotherapy, Tolerance, Allergic rhinitis, Asthma, Seasonal variation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Allergy Immunotherapy Group

Arm Type

Experimental

Arm Description

There is only one active experimental group as this is a pilot study comparing clinical/histologic/endoscopic changes before and after treatment.

Intervention Type

Biological

Intervention Name(s)

Allergy immunotherapy ("allergy shots")

Primary Outcome Measure Information:

Title

Histologic change

Description

Subjects will be started on allergy immunotherapy. We will compare before and after pathology - changes in eosinophils per high power field in esophageal biopsy.

Time Frame

1 year after after starting allergy immunotherapy

Secondary Outcome Measure Information:

Title

Symptomatic changes

Description

Symptom questionaire will be assessed before intervention and after (about 1 year after being on allergy immunotherapy)

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

Endoscopic changes

Description

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.

Time Frame

1 year

Title

Eosinophilia change

Description

Absolute eosinophilic counts will be measured before and after intervention.

Time Frame

1 year

Title

Adverse outcomes

Description

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.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

12. IPD Sharing Statement

Citations:

PubMed Identifier

19240704

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.

Results Reference

background

PubMed Identifier

15867873

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.

Results Reference

background

PubMed Identifier

11134183

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.

Results Reference

background

PubMed Identifier

19925501

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.

Results Reference

background

PubMed Identifier

19564792

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.

Results Reference

background

PubMed Identifier

16297137

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.

Results Reference

background

PubMed Identifier

14564365

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.

Results Reference

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Allergy Immunotherapy in the Management of Eosinophilic Esophagitis

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