Food AllergyPhase 2CoFAR7NCT01846208
Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy
A Phase 2 study testing Egg Oral Immunotherapy and Baked Egg in people with Food Allergy, run by Hugh A Sampson, MD at 5 sites in United States.
Trial summary
The purpose of this study is to compare Baked Egg vs. Egg Oral Immunotherapy for inducing sustained unresponsiveness to egg exposure in children. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- Egg Oral Immunotherapy and Baked Egg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2013to 30 Sep 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
National Jewish Health
Denver, Colorado, 80206
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Icahn School of Medicine at Mount Sinai
New York, New York, 100029
About this study
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 purpose of this study is to compare Baked Egg vs. Egg Oral Immunotherapy for inducing sustained unresponsiveness to egg exposure in children.
Read the 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.
- Conditions
- Food Allergy
- Being tested
- Egg Oral Immunotherapy, Baked Egg
- Keywords
- Egg Allergy, Egg Oral Immunotherapy, Food Allergy
- Medical subject headings
- Food Hypersensitivity, Egg Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg Oral ImmunotherapyDrug
Also called Egg white solid
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.
Baked EggDrug
Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.
| Study group | Role | What they receive |
|---|---|---|
| Egg OIT Randomized | Experimental | 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. Receives: Drug: Egg Oral Immunotherapy |
| Baked Egg Randomized | Experimental | 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. Receives: Drug: Baked Egg |
| Egg OIT Assigned | Experimental | 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. Receives: Drug: Egg Oral Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Unresponsiveness to Egg Consumption at 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.
Measured: 2 Years
Secondary outcomes (3)
Desensitization to >= 4.444 Grams Egg White Solid.
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.
Measured: 1 Year and 2 Years
Incidence of All Serious Adverse Events
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.
Measured: up to 3 years
Number of Participants With Unrestricted Consumption of Unbaked Egg
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.
Measured: 3 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startJul 2013
- Primary completion28 Sep 2017
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugh A Sampson, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Consortium of Food Allergy Research
- Responsible party
- Sponsor-investigator, Hugh A Sampson, MD, Icahn School of Medicine at Mount Sinai
- Investigators
- Hugh A Sampson, MD, Study chair, Icahn School of Medicine at Mount SinaiRobert Wood, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846208
- Sponsor's protocol ID
- GCO 04-1271
- Other IDs
- U19AI066738, CoFAR7
- Acronym
- CoFAR7
- Status last verified
- Jul 2019
- First submitted
- 30 Apr 2013
- Last updated
- 26 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Desensitization to Egg With Subsequent Induction of Sustained Unresponsiveness for Egg-Allergic Children Using Baked Egg or Egg Oral Immunotherapy (OIT)
- ClinicalTrials.gov ID
- NCT01846208
- Acronym / sponsor ID
- CoFAR7 / GCO 04-1271
- Conditions
- Food Allergy
- Keywords
- Egg Allergy, Egg Oral Immunotherapy, Food Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Hugh A Sampson, MDUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Consortium of Food Allergy Research
- Study start
- Jul 2013
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Posted 30 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Egg OIT Randomized | Experimental | Drug: Egg Oral ImmunotherapySubjects 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. |
| Baked Egg Randomized | Experimental | Drug: Baked EggSubjects 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. |
| Egg OIT Assigned | Experimental | Drug: Egg Oral ImmunotherapySubjects 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. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Egg Oral ImmunotherapyAlso: Egg white solidCommercially 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. | Drug | Egg OIT Assigned, Egg OIT Randomized |
| Baked EggPredetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions. | Drug | Baked Egg Randomized |
Primary outcome
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.
3 secondary outcomes
Desensitization to >= 4.444 Grams Egg White Solid.
Time frame: 1 Year and 2 Years
Incidence of All Serious Adverse Events
Time frame: up to 3 years
Number of Participants With Unrestricted Consumption of Unbaked Egg
Time frame: 3 years after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Study Web SiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugh A Sampson, MD study chair
Icahn School of Medicine at Mount Sinai
Robert Wood, MD principal investigator
Johns Hopkins University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Egg Oral Immunotherapy and Baked Egg in people with Food Allergy, run by Hugh A Sampson, MD at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Unresponsiveness to Egg Consumption at 2 Years. (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.