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

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ClinicalTrials.gov Identifier: NCT01846208
Recruitment Status : Completed
First Posted : May 3, 2013
Results First Posted : October 30, 2018
Last Update Posted : July 26, 2019
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Consortium of Food Allergy Research
Information provided by (Responsible Party):
Hugh A Sampson, MD, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE April 30, 2013
First Posted Date  ICMJE May 3, 2013
Results First Submitted Date  ICMJE September 24, 2018
Results First Posted Date  ICMJE October 30, 2018
Last Update Posted Date July 26, 2019
Study Start Date  ICMJE July 2013
Actual Primary Completion Date September 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
Sustained Unresponsiveness to Egg Consumption at 2 Years. [ Time Frame: 2 Years ]
Sustained unresponsiveness - able to successfully consume 7444 mg egg white protein in a desensitization OFC and, after an 8-10 week egg-free interval, were also able to successfully consume 7444 mg egg white protein in an OFC after up to 2 years of therapy.
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2013)
The development of sustained unresponsiveness to egg consumption at 2 years. [ Time Frame: 2 Years ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2019)
  • Desensitization to >= 4.444 Grams Egg White Solid. [ Time Frame: 1 Year and 2 Years ]
    Development of desensitization to able to successfully consume >=4444 mg egg white protein during a desensitization OFC on therapy at 1 year and 2 years.
  • Incidence of All Serious Adverse Events [ Time Frame: up to 3 years ]
    Incidence of all serious adverse events during the study. No statistical analyses were performed since there were no events in 2 of the 3 treatment groups and only 1 event in the third so it would not be meaningful.
  • Number of Participants With Unrestricted Consumption of Unbaked Egg [ Time Frame: 3 years after randomization ]
    Number of participants who reported consumption of concentrated (unbaked) egg in their diet on the long-term follow-up questionnaire 3 years after randomization, indicating unrestricted consumption of unbaked egg. This is a qualitative questionnaire asking participants about egg in their diet, symptoms, and what treatment they received for their allergic reactions.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2013)
  • The development of desensitization to >= 5 grams egg white solid. [ Time Frame: 1 Year and 2 Years ]
    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 ]
  • Changes in egg-specific mechanistic measures and prick skin test results. [ Time Frame: 2 Years ]
    Changes in egg-specific IgE and IgG4, changes in PST mean wheal diameters, basophil reactivity, Th2 and Treg values.
Current Other Pre-specified Outcome Measures
 (submitted: October 4, 2018)
Changes in Egg-specific Mechanistic Measures and Skin Prick Test Results. [ Time Frame: 2 Years ]
Changes in egg-specific IgE and IgG4, changes in SPT mean wheal diameters, basophil reactivity, Th2 and Treg values.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy
Official Title  ICMJE Oral Desensitization to Egg With Subsequent Induction of Sustained Unresponsiveness for Egg-Allergic Children Using Baked Egg or Egg Oral Immunotherapy (OIT)
Brief Summary The purpose of this study is to compare Baked Egg vs. Egg Oral Immunotherapy for inducing sustained unresponsiveness to egg exposure in children.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Food Allergy
Intervention  ICMJE
  • 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
  • Drug: Baked Egg
    Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.
Study Arms  ICMJE
  • Experimental: Egg OIT Randomized
    Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol.
    Intervention: Drug: Egg Oral Immunotherapy
  • Experimental: Baked Egg Randomized
    Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive 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.
    Intervention: Drug: Baked Egg
  • Experimental: Egg OIT Assigned
    Subjects who failed a baked egg oral food challenge (OFC) at baseline were assigned to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol.
    Intervention: Drug: Egg Oral Immunotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2016)
92
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2013)
130
Actual Study Completion Date  ICMJE September 30, 2018
Actual Primary Completion Date September 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01846208
Other Study ID Numbers  ICMJE GCO 04-1271
U19AI066738 ( U.S. NIH Grant/Contract )
CoFAR7 ( Other Identifier: Consortium of Food Allergy Research )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hugh A Sampson, MD, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Hugh A Sampson, MD
Collaborators  ICMJE
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Consortium of Food Allergy Research
Investigators  ICMJE
Study Chair: Hugh A Sampson, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Robert Wood, MD Johns Hopkins University
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP