Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy (CoFAR7)
The purpose of this study is to compare Baked Egg vs. Egg Oral Immunotherapy for inducing sustained unresponsiveness to egg exposure in children.
|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)|
- 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.
- 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.
|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)|
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.
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.
|United States, Arkansas|
|Arkansas Children's Hospital||Recruiting|
|Little Rock, Arkansas, United States, 72202|
|Contact: Suzanna Carlisle, RN 501-364-3749 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: David M Fleischer, MD|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Rachel Brewer, RN 410-502-1711 email@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: A W Burks, MD|
|Study Chair:||Hugh A Sampson, MD||Mount Sinai School of Medicine|
|Principal Investigator:||Robert Wood, MD||Johns Hopkins University|