Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy (CoFAR7)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Mount Sinai School of Medicine
Sponsor:
Collaborators:
Consortium of Food Allergy Research
Information provided by (Responsible Party):
Hugh.Sampson, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01846208
First received: April 30, 2013
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to compare Baked Egg vs. Egg Oral Immunotherapy for inducing sustained unresponsiveness to egg exposure in children.


Condition Intervention Phase
Food Allergy
Drug: Egg Oral Immunotherapy
Drug: Baked Egg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Desensitization to Egg With Subsequent Induction of Sustained Unresponsiveness for Egg-Allergic Children Using Baked Egg or Egg Oral Immunotherapy (OIT)

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • The development of sustained unresponsiveness to egg consumption at 2 years. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    The primary clinical efficacy end-point is the development of sustained unresponsiveness to egg consumption at 2 years as assessed with a 10 gm egg OFC and open feeding, 8-10 weeks after discontinuing therapy.


Secondary Outcome Measures:
  • The development of desensitization to >= 5 grams egg white solid. [ Time Frame: 1 Year and 2 Years ] [ Designated as safety issue: No ]
    The development of desensitization to >= 5 grams egg white solid at 1 year and two years.

  • Incidence of all serious adverse events during the study. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
  • Changes in egg-specific mechanistic measures and prick skin test results. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Changes in egg-specific IgE and IgG4, changes in PST mean wheal diameters, basophil reactivity, Th2 and Treg values.


Estimated Enrollment: 130
Study Start Date: July 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Egg OIT
Egg Oral Immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol.
Drug: Egg Oral Immunotherapy
Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.
Other Name: Egg white solid
Experimental: Baked Egg
Baked Egg in the form of home-baked goods and "safe" commercial products with up to four oral food challenges as directed by the protocol.
Drug: Baked Egg
Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.

Detailed Description:

Food allergy affects 6-8 percent of children in the United States. In young children, reactions to egg can range from hives to severe life threatening allergic reactions called anaphylaxis. Current treatment for food allergy is complete avoidance of the food and to carry antihistamines and self-injectable epinephrine if an accidental reaction occurs. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since immunotherapy injections for food allergy are associated with a high rate of allergic reactions, alternate approaches to treatment are needed. Oral (by mouth) immunotherapy (OIT) is one approach that has been tried in some studies in the treatment of food allergies. The purpose of this study is to compare baked foods with egg versus (vs.) egg OIT. The intent of the study is to investigate if participants will be able to consume egg after taking baked foods with egg or egg OIT for a period of time and then stopping for a certain period. This is referred to as tolerance or sustained unresponsiveness. This study will evaluate the effectiveness of the egg OIT vs. baked egg by having each participant ingest egg white solid or baked foods with egg. This will be done over 2 years.

This study will last 2 years. All eligible subjects will receive a baked egg oral food challenge (OFC). Those who pass the baked egg OFC will then have a 2 gm egg OFC. Those who react to the egg OFC will be randomized to Baked Egg or Egg OIT. Individuals who do not pass the initial baked egg OFC will be assigned to Egg OIT. Those who pass the egg OFC will not be eligible for the study and will be followed per site standard of care. All eligible and enrolled subjects will have a 1-year and a 2-year OFC.

At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur.

  Eligibility

Ages Eligible for Study:   3 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 3 through 16 years with a serum IgE to egg of >= 5 kUA/L within the past 12 months]
  • Reacting to the initial baked egg OFC with dose limiting symptoms OR
  • Reacting on a 2 gm egg OFC with dose limiting symptoms to a cumulative dose of 2 gm or less after passing the initial baked egg OFC
  • Written informed consent from subject and/or parent/guardian
  • Written assent from all subjects as appropriate
  • All females of child bearing age must be using appropriate birth control

Exclusion Criteria:

  • History of anaphylaxis to egg resulting in hypotension, neurological compromise or mechanical ventilation
  • Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
  • Active eosinophilic gastrointestinal disease in the past 2 years
  • Participation in any interventional study for the treatment of food allergy in the past 6 months
  • Subject is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing). Subjects tolerating maintenance allergen immunotherapy can be enrolled.
  • Severe asthma, or uncontrolled mild or moderate asthma. More information on these exclusion criteria can be found in the protocol.
  • Inability to discontinue antihistamines for initial day escalation, skin testing or OFC
  • Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic therapy (e.g. infliximab, rituximab, etc.) within the past year
  • Use of Beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
  • Use of investigational drug within 90 days or plan to use investigational drug during the study period
  • Pregnancy or lactation
  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: NCT01846208

Locations
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Suzanna Carlisle, RN    501-364-3749    carlislesuzannak@uams.edu   
Contact: Denise Pearson, RN    501-364-1998    PearsonDR@archildrens.org   
Principal Investigator: Stacie Jones, MD         
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Susan Leung, RN    303-398-1549    leungs@njhealth.org   
Principal Investigator: Donald YM Leung, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Rachel Brewer, RN    410-502-1711    rbrewer3@jhmi.edu   
Contact: Kim Mudd, RN    410-502-1711    Kmudd2@jhmi.edu   
Principal Investigator: Robert Wood, MD         
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 100029
Contact: Lisa Talarico, RN    212-241-7566    lisa.talarico@mssm.edu   
Principal Investigator: Hugh A Sampson, MD         
United States, North Carolina
University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Pamela Steele, MSN, CPNP    919-966-4647    phsteele@email.unc.edu   
Principal Investigator: A W Burks, MD         
Sponsors and Collaborators
Hugh.Sampson
Consortium of Food Allergy Research
Investigators
Study Chair: Hugh A Sampson, MD Mount Sinai School of Medicine
Principal Investigator: Robert Wood, MD Johns Hopkins University
  More Information

Additional Information:
No publications provided

Responsible Party: Hugh.Sampson, Dean for Translational Biomedical Sciences, Director, Jaffe Food Allergy Institute, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01846208     History of Changes
Other Study ID Numbers: GCO 04-1271, U19AI066738, CoFAR7
Study First Received: April 30, 2013
Last Updated: April 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
Egg Allergy
Egg Oral Immunotherapy
Food Allergy

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Egg Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on July 23, 2014