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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Food Allergy
Interventions Drug: Egg Oral Immunotherapy
Drug: Baked Egg
Enrollment 92
Recruitment Details Study recruitment began in July 2013 and accrual closed in August 2015.
Pre-assignment Details  
Arm/Group Title Baked Egg Randomized Egg OIT Randomized Egg OIT Assigned
Hide Arm/Group Description

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.

Baked Egg: Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.

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.

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.

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.

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.

Period Title: Overall Study
Started 28 24 40
Initiatiated Treatment 27 23 39
Year 1 Desensitization OFC [1] 23 20 34
Year 2 Desensitization OFC [2] 19 20 33
Year 2 Sustained Unresponsiveness OFC [3] 4 18 21
Completed 19 20 32
Not Completed 9 4 8
Reason Not Completed
Withdrew prior to treatment             1             1             1
Dosing Symptoms             1             2             6
Withdrawal by Subject             5             0             0
Non-compliance             1             1             0
Developed Eosinophilic Esophagitis (EoE)             1             0             0
Refused SU OFC             0             0             1
[1]
OFC = oral food challenge
[2]
Completed Year 2 desensitization oral food challenge
[3]
Completed Year 2 sustained unresponsiveness oral food challenge (SU OFC)
Arm/Group Title Baked Egg Randomized Egg OIT Randomized Egg OIT Assigned Total
Hide Arm/Group Description

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.

Baked Egg: Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.

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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 27 23 39 89
Hide Baseline Analysis Population Description
Only treated participants are included in analysis
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 23 participants 39 participants 89 participants
7.2  (3.0) 9.1  (3.1) 8.8  (2.4) 8.4  (2.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 23 participants 39 participants 89 participants
Female
12
  44.4%
6
  26.1%
14
  35.9%
32
  36.0%
Male
15
  55.6%
17
  73.9%
25
  64.1%
57
  64.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 23 participants 39 participants 89 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   7.4%
2
   8.7%
4
  10.3%
8
   9.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   3.7%
2
   8.7%
0
   0.0%
3
   3.4%
White
23
  85.2%
18
  78.3%
31
  79.5%
72
  80.9%
More than one race
1
   3.7%
1
   4.3%
4
  10.3%
6
   6.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 23 participants 39 participants 89 participants
Non-Hispanic or Non-Latino origin
25
  92.6%
23
 100.0%
39
 100.0%
87
  97.8%
Hispanic or Latino origin
2
   7.4%
0
   0.0%
0
   0.0%
2
   2.2%
Other Food Allergy History  
Measure Type: Count of Participants
Unit of measure:  Participants
No/Unknown Number Analyzed 27 participants 23 participants 39 participants 89 participants
1
   3.7%
3
  13.0%
8
  20.5%
12
  13.5%
Yes Number Analyzed 27 participants 23 participants 39 participants 89 participants
26
  96.3%
20
  87.0%
31
  79.5%
77
  86.5%
Asthma Severity History  
Measure Type: Count of Participants
Unit of measure:  Participants
No History Number Analyzed 27 participants 23 participants 39 participants 89 participants
9
  33.3%
10
  43.5%
13
  33.3%
32
  36.0%
Mild intermittent Number Analyzed 27 participants 23 participants 39 participants 89 participants
16
  59.3%
10
  43.5%
24
  61.5%
50
  56.2%
Mild persistent Number Analyzed 27 participants 23 participants 39 participants 89 participants
1
   3.7%
2
   8.7%
2
   5.1%
5
   5.6%
Moderate persistent Number Analyzed 27 participants 23 participants 39 participants 89 participants
1
   3.7%
1
   4.3%
0
   0.0%
2
   2.2%
Allergic GI Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 23 participants 39 participants 89 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Allergic Rhinitis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 23 participants 39 participants 89 participants
24
  88.9%
18
  78.3%
31
  79.5%
73
  82.0%
Atopic Dermatitis History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 23 participants 39 participants 89 participants
18
  66.7%
13
  56.5%
24
  61.5%
55
  61.8%
Atopic Dermatitis Score   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 27 participants 23 participants 39 participants 89 participants
0.0
(0 to 5.0)
0.0
(0 to 5.0)
0.0
(0 to 4.0)
0.0
(0 to 5.0)
[1]
Measure Description: The Atopic Dermatitis Total Score is scored on a 10 point scale of 0 to 9 where a higher score indicates increasing severity of atopic dermatitis. This score is a combination of three scores that range from 0 to 3 in the following areas: body surface area score, disease course, and disease intensity.
Baseline Egg IgE   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  kUA/L
Number Analyzed 27 participants 23 participants 38 participants 88 participants
9.77
(6.54 to 27.10)
12.30
(9.09 to 31.10)
26.25
(11.7 to 68.80)
15.60
(8.22 to 37.65)
[1]
Measure Description: Assay limits of detection Ranges: 0.01 to 100 kUA/L, Values outside of range were truncated (lower and upper values): 0.05 and 101 kUA/L
[2]
Measure Analysis Population Description: One participant in Egg OIT Assigned arm had no plasma
Baseline Total IgE   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  kUA/L
Number Analyzed 27 participants 23 participants 38 participants 88 participants
809.00
(389.00 to 1870.00)
873.00
(269.00 to 1671.00)
960.00
(390.00 to 1659.00)
885.50
(366.50 to 1699.00)
[1]
Measure Description: Assay limits of detection ranges: Total IgE: 5000 kU/L upper limit, Values above range were truncated: 5001 kU/L
[2]
Measure Analysis Population Description: One participant in Egg OIT Assigned arm had no plasma
Baseline Egg IgG4   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  mgA/L
Number Analyzed 27 participants 23 participants 38 participants 88 participants
0.84
(0.08 to 7.31)
0.81
(0.26 to 3.71)
0.28
(0.13 to 1.02)
0.64
(0.17 to 1.84)
[1]
Measure Description: Assay limits of detection ranges: 0.07 to 30 mgA/L, Values outside of range were truncated (lower and upper values): 0.035 and 31 mgA/L
[2]
Measure Analysis Population Description: One participant in Egg OIT Assigned arm had no plasma
Baseline Egg %IgE   [1] 
Median (Inter-Quartile Range)
Unit of measure:  % IgE
Number Analyzed 27 participants 23 participants 38 participants 88 participants
1.86
(0.89 to 3.62)
1.80
(0.97 to 5.29)
3.06
(1.21 to 5.86)
2.13
(1.03 to 4.29)
[1]
Measure Analysis Population Description: One participant in Egg OIT Assigned arm had no plasma
Baseline Ratio IgG4/IgE   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Ratio
Number Analyzed 27 participants 23 participants 38 participants 88 participants
24.94
(2.23 to 119.64)
25.75
(11.13 to 86.55)
5.01
(2.79 to 11.24)
11.18
(3.86 to 42.25)
[1]
Measure Analysis Population Description: One participant in Egg OIT Assigned arm had no plasma
Baseline Ovalbumin IgE   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  kUA/L
Number Analyzed 27 participants 23 participants 38 participants 88 participants
5.53
(3.20 to 20.20)
5.85
(3.41 to 10.40)
16.10
(7.30 to 29.70)
8.88
(4.11 to 20.20)
[1]
Measure Description: Assay limits of detection ranges: 0.01 to 100 kUA/L, Values outside of range were truncated (lower and upper values): 0.05 and 101 kUA/L
[2]
Measure Analysis Population Description: One participant in Egg OIT Assigned arm had no plasma
Baseline Ovomucoid IgE   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  kUA/L
Number Analyzed 27 participants 23 participants 38 participants 88 participants
6.94
(1.52 to 13.40)
6.93
(3.27 to 13.20)
16.40
(6.11 to 35.50)
9.76
(3.48 to 18.95)
[1]
Measure Description: Assay limits of detection ranges: 0.01 to 100 kUA/L, Values outside of range were truncated (lower and upper values): 0.05 and 101 kUA/L
[2]
Measure Analysis Population Description: One participant in Egg OIT Assigned arm had no plasma
Baseline Ovalbumin IgG4   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  mgA/L
Number Analyzed 27 participants 23 participants 38 participants 88 participants
0.64
(0.14 to 5.23)
0.53
(0.09 to 1.93)
0.33
(0.16 to 1.04)
0.49
(0.14 to 1.93)
[1]
Measure Description: Assay limits of detection ranges: 0.07 to 30 mgA/L, Values outside of range were truncated (lower and upper values): 0.035 and 31 mgA/L
[2]
Measure Analysis Population Description: One participant in Egg OIT Assigned arm had no plasma
Baseline Ovomucoid IgG4   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  mgA/L
Number Analyzed 27 participants 23 participants 38 participants 88 participants
0.25
(0.04 to 1.34)
0.15
(0.04 to 2.49)
0.09
(0.04 to 0.26)
0.11
(0.04 to 0.60)
[1]
Measure Description: Assay limits of detection ranges: 0.07 to 30 mgA/L, Values outside of range were truncated (lower and upper values): 0.035 and 31 mgA/L
[2]
Measure Analysis Population Description: One participant in Egg OIT Assigned arm had no plasma
Baseline Egg Skin Prick Test (SPT)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Mms
Number Analyzed 27 participants 23 participants 39 participants 89 participants
7.50
(5.50 to 13.50)
11.00
(6.50 to 15.00)
12.00
(7.50 to 16.50)
11.00
(6.50 to 15.00)
[1]
Measure Description: Skin prick tests performed using study approved procedures for food and environmental allergens. A skin test probe is pressed through a commercial extract of an allergen into the epidermis.
Baseline Milk SPT  
Median (Inter-Quartile Range)
Unit of measure:  Mms
Number Analyzed 27 participants 23 participants 39 participants 89 participants
1.00
(0 to 10.00)
3.00
(0 to 8.50)
3.50
(0 to 44.00)
2.50
(0 to 44.00)
Baseline Peanut SPT   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Mms
Number Analyzed 27 participants 23 participants 38 participants 88 participants
10.50
(3.50 to 17.00)
11.00
(8.50 to 17.50)
10.50
(1.75 to 21.00)
11.00
(3.25 to 17.50)
[1]
Measure Analysis Population Description: One Egg OIT Assigned subject refused to complete the peanut SPT at baseline
Baseline Tree SPT  
Median (Inter-Quartile Range)
Unit of measure:  Mms
Number Analyzed 27 participants 23 participants 39 participants 89 participants
2.50
(0 to 7.00)
4.50
(0 to 8.50)
3.00
(0 to 6.50)
3.50
(0 to 7.00)
Baseline Grass SPT  
Median (Inter-Quartile Range)
Unit of measure:  Mms
Number Analyzed 27 participants 23 participants 39 participants 89 participants
4.50
(0 to 7.00)
0.00
(0 to 6.50)
2.50
(0 to 6.50)
2.50
(0 to 6.50)
Baseline Weed SPT  
Median (Inter-Quartile Range)
Unit of measure:  Mms
Number Analyzed 27 participants 23 participants 39 participants 89 participants
1.50
(0 to 5.50)
0.00
(0 to 3.50)
0.00
(0 to 3.50)
0.00
(0 to 4.00)
Baseline Mold SPT  
Median (Inter-Quartile Range)
Unit of measure:  Mms
Number Analyzed 27 participants 23 participants 39 participants 89 participants
0.50
(0 to 4.00)
1.00
(0 to 4.50)
0.00
(0 to 3.50)
0.00
(0 to 3.50)
Baseline Cockroach SPT  
Median (Inter-Quartile Range)
Unit of measure:  Mms
Number Analyzed 27 participants 23 participants 39 participants 89 participants
0.00
(0 to 1.50)
0.00
(0 to 3.00)
0.00
(0 to 2.50)
0.00
(0 to 2.50)
1.Primary Outcome
Title Sustained Unresponsiveness to Egg Consumption at 2 Years.
Hide Description 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.
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants were included in the analysis.
Arm/Group Title Baked Egg Randomized Egg OIT Randomized Egg OIT Assigned
Hide Arm/Group Description:

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.

Baked Egg: Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.

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.

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.

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.

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.

Overall Number of Participants Analyzed 27 23 39
Measure Type: Count of Participants
Unit of Measure: Participants
3
  11.1%
10
  43.5%
7
  17.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baked Egg Randomized, Egg OIT Randomized
Comments % participants passed Year 2 SU OFC: Baked vs. Egg OIT-Randomized
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Barnard's Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 32.4
Confidence Interval (2-Sided) 95%
8.9 to 55.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Egg OIT Randomized, Egg OIT Assigned
Comments % participants passed Year 2 SU OFC: Egg OIT-Randomized vs. Egg OIT-Assigned
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method Barnard's Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 25.5
Confidence Interval (2-Sided) 95%
2.0 to 49.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Desensitization to >= 4.444 Grams Egg White Solid.
Hide Description 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.
Time Frame 1 Year and 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baked Egg Randomized Egg OIT Randomized Egg OIT Assigned
Hide Arm/Group Description:

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.

Baked Egg: Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.

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.

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.

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.

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.

Overall Number of Participants Analyzed 27 23 39
Measure Type: Count of Participants
Unit of Measure: Participants
Desensitized Success at Year 1
8
  29.6%
17
  73.9%
22
  56.4%
Desensitized Success at Year 2
6
  22.2%
20
  87.0%
27
  69.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baked Egg Randomized, Egg OIT Randomized
Comments % participants desensitized to >=4444 mg at Year 2 OFC: Baked vs. Egg OIT-Randomized
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Barnard's Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 64.7
Confidence Interval (2-Sided) 95%
43.9 to 85.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Egg OIT Randomized, Egg OIT Assigned
Comments % participants desensitized to >=4444 mg at Year 2 OFC: Egg OIT-Randomized vs. Egg OIT-Assigned
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.151
Comments [Not Specified]
Method Barnard's Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 17.7
Confidence Interval (2-Sided) 95%
-2.3 to 37.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Baked Egg Randomized, Egg OIT Randomized
Comments % participants desensitized to >=4444 mg at Year 1 OFC: Baked vs. Egg OIT-Randomized
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Barnard's Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 44.3
Confidence Interval (2-Sided) 95%
19.4 to 69.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Egg OIT Randomized, Egg OIT Assigned
Comments % participants desensitized to >=4444 mg at Year 1 OFC: Egg OIT-Randomized vs. Egg OIT-Assigned
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.181
Comments [Not Specified]
Method Barnard's Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 17.5
Confidence Interval (2-Sided) 95%
-6.3 to 41.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Incidence of All Serious Adverse Events
Hide Description

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.

Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Baked Egg Randomized Egg OIT Randomized Egg OIT Assigned
Hide Arm/Group Description:

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.

Baked Egg: Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.

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.

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.

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.

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.

Overall Number of Participants Analyzed 27 23 39
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   2.6%
4.Secondary Outcome
Title Number of Participants With Unrestricted Consumption of Unbaked Egg
Hide Description 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.
Time Frame 3 years after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the long term follow-up questionnaire 3 years after randomization are included.
Arm/Group Title Baked Egg Randomized Egg OIT Randomized Egg OIT Assigned
Hide Arm/Group Description:

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.

Baked Egg: Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.

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.

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.

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.

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.

Overall Number of Participants Analyzed 17 19 30
Measure Type: Count of Participants
Unit of Measure: Participants
4
  23.5%
14
  73.7%
12
  40.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baked Egg Randomized, Egg OIT Randomized
Comments % participants with unrestricted consumption of unbaked (concentrated) egg 3 years after randomization: Baked vs. Egg OIT-Randomized
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Barnard's Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -50.2
Confidence Interval (2-Sided) 95%
-78.4 to -21.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Egg OIT Randomized, Egg OIT Assigned
Comments % participants with unrestricted consumption of unbaked (concentrated) egg 3 years after randomization: Egg OIT-Randomized vs. Egg OIT-Assigned
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method Barnard's Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 33.7
Confidence Interval (2-Sided) 95%
7.2 to 60.1
Estimation Comments [Not Specified]
5.Other Pre-specified Outcome
Title Changes in Egg-specific Mechanistic Measures and Skin Prick Test Results.
Hide Description Changes in egg-specific IgE and IgG4, changes in SPT mean wheal diameters, basophil reactivity, Th2 and Treg values.
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Data not reported because these are for tertiary objectives that are exploratory.
Arm/Group Title Baked Egg Randomized Egg OIT Randomized Egg OIT Assigned
Hide Arm/Group Description:

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.

Baked Egg: Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.

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.

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.

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.

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.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame up to 3 years, through last clinic visit.
Adverse Event Reporting Description

* Unsolicited - collected by non-systematic assessment

+ Solicited (dosing symptoms from daily logs) - collected by systematic assessment

 
Arm/Group Title Baked Egg Randomized Egg OIT Randomized Egg OIT Assigned
Hide Arm/Group Description

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.

Baked Egg: Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.

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.

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.

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.

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.

All-Cause Mortality
Baked Egg Randomized Egg OIT Randomized Egg OIT Assigned
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)      0/23 (0.00%)      0/39 (0.00%)    
Hide Serious Adverse Events
Baked Egg Randomized Egg OIT Randomized Egg OIT Assigned
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      0/23 (0.00%)      1/39 (2.56%)    
Infections and infestations       
Pneumonia  1  0/27 (0.00%)  0/23 (0.00%)  1/39 (2.56%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Baked Egg Randomized Egg OIT Randomized Egg OIT Assigned
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/27 (100.00%)      23/23 (100.00%)      39/39 (100.00%)    
Ear and labyrinth disorders       
Ear pain+  1  0/27 (0.00%)  0 2/23 (8.70%)  2 0/39 (0.00%)  0
Eye disorders       
Eyelid oedema+  2  0/27 (0.00%)  0 0/23 (0.00%)  0 2/39 (5.13%)  2
Ocular hyperaemia+  2  0/27 (0.00%)  0 0/23 (0.00%)  0 2/39 (5.13%)  3
Gastrointestinal disorders       
Abdominal discomfort* * 2  0/27 (0.00%)  0 0/23 (0.00%)  0 2/39 (5.13%)  2
Abdominal discomfort+  2  13/27 (48.15%)  41 15/23 (65.22%)  244 31/39 (79.49%)  2030
Abdominal pain upper* * 2  0/27 (0.00%)  0 5/23 (21.74%)  7 2/39 (5.13%)  3
Abdominal pain* * 2  0/27 (0.00%)  0 4/23 (17.39%)  4 1/39 (2.56%)  1
Abdominal pain+  2  0/27 (0.00%)  0 3/23 (13.04%)  5 10/39 (25.64%)  37
Diarrhoea* * 2  2/27 (7.41%)  2 5/23 (21.74%)  6 9/39 (23.08%)  10
Diarrhoea+  1  1/27 (3.70%)  1 2/23 (8.70%)  3 7/39 (17.95%)  15
Dyspepsia+  2  0/27 (0.00%)  0 0/23 (0.00%)  0 2/39 (5.13%)  22
Flatulence+  1  0/27 (0.00%)  0 0/23 (0.00%)  0 2/39 (5.13%)  49
Gastrointestinal disorder* * 2  0/27 (0.00%)  0 2/23 (8.70%)  2 0/39 (0.00%)  0
Lip swelling+  1  0/27 (0.00%)  0 0/23 (0.00%)  0 2/39 (5.13%)  2
Nausea* * 2  0/27 (0.00%)  0 0/23 (0.00%)  0 2/39 (5.13%)  2
Nausea+  1  0/27 (0.00%)  0 1/23 (4.35%)  2 6/39 (15.38%)  28
Oral discomfort+  1  1/27 (3.70%)  1 0/23 (0.00%)  0 2/39 (5.13%)  2
Oral disorder+  2  19/27 (70.37%)  269 16/23 (69.57%)  487 36/39 (92.31%)  895
Tongue pruritus+  1  0/27 (0.00%)  0 1/23 (4.35%)  5 2/39 (5.13%)  2
Vomiting* * 2  3/27 (11.11%)  3 5/23 (21.74%)  10 3/39 (7.69%)  4
Vomiting+  2  5/27 (18.52%)  9 8/23 (34.78%)  20 20/39 (51.28%)  62
General disorders       
Chest discomfort+  1  0/27 (0.00%)  0 1/23 (4.35%)  2 3/39 (7.69%)  16
Influenza like illness* * 2  0/27 (0.00%)  0 0/23 (0.00%)  0 2/39 (5.13%)  2
Malaise+  1  0/27 (0.00%)  0 0/23 (0.00%)  0 3/39 (7.69%)  13
Pyrexia* * 2  7/27 (25.93%)  7 7/23 (30.43%)  13 12/39 (30.77%)  22
Immune system disorders       
Allergy to animal* * 1  1/27 (3.70%)  1 1/23 (4.35%)  1 4/39 (10.26%)  6
Hypersensitivity* * 2  1/27 (3.70%)  1 3/23 (13.04%)  3 1/39 (2.56%)  1
Infections and infestations       
Bronchitis* * 2  3/27 (11.11%)  3 0/23 (0.00%)  0 0/39 (0.00%)  0
Cellulitis* * 2  0/27 (0.00%)  0 2/23 (8.70%)  2 1/39 (2.56%)  1
Croup infectious* * 2  1/27 (3.70%)  1 0/23 (0.00%)  0 2/39 (5.13%)  2
Ear infection* * 2  1/27 (3.70%)  1 2/23 (8.70%)  2 2/39 (5.13%)  2
Febrile infection* * 2  2/27 (7.41%)  2 1/23 (4.35%)  1 0/39 (0.00%)  0
Gastroenteritis viral* * 2  3/27 (11.11%)  4 5/23 (21.74%)  7 8/39 (20.51%)  11
Gastroenteritis* * 2  4/27 (14.81%)  5 2/23 (8.70%)  3 5/39 (12.82%)  6
Gastrointestinal viral infection* * 2  5/27 (18.52%)  8 4/23 (17.39%)  5 5/39 (12.82%)  9
Influenza* * 2  2/27 (7.41%)  2 2/23 (8.70%)  3 4/39 (10.26%)  5
Lice infestation* * 2  2/27 (7.41%)  2 0/23 (0.00%)  0 0/39 (0.00%)  0
Localised infection* * 2  1/27 (3.70%)  1 0/23 (0.00%)  0 2/39 (5.13%)  2
Otitis media* * 2  2/27 (7.41%)  2 1/23 (4.35%)  1 1/39 (2.56%)  1
Pharyngitis streptococcal* * 2  4/27 (14.81%)  4 4/23 (17.39%)  4 5/39 (12.82%)  6
Sinusitis* * 2  2/27 (7.41%)  3 1/23 (4.35%)  2 3/39 (7.69%)  3
Upper respiratory tract infection* * 1  11/27 (40.74%)  21 10/23 (43.48%)  15 11/39 (28.21%)  15
Viral infection* * 2  4/27 (14.81%)  5 6/23 (26.09%)  8 5/39 (12.82%)  7
Viral upper respiratory tract infection* * 2  8/27 (29.63%)  14 5/23 (21.74%)  10 8/39 (20.51%)  11
Injury, poisoning and procedural complications       
Concussion* * 2  0/27 (0.00%)  0 0/23 (0.00%)  0 2/39 (5.13%)  2
Nervous system disorders       
Headache* * 2  0/27 (0.00%)  0 5/23 (21.74%)  8 3/39 (7.69%)  3
Headache+  1  0/27 (0.00%)  0 0/23 (0.00%)  0 2/39 (5.13%)  16
Respiratory, thoracic and mediastinal disorders       
Asthma* * 2  6/27 (22.22%)  8 4/23 (17.39%)  4 4/39 (10.26%)  5
Cough* * 2  3/27 (11.11%)  5 9/23 (39.13%)  16 3/39 (7.69%)  3
Cough+  2  4/27 (14.81%)  14 8/23 (34.78%)  9 10/39 (25.64%)  39
Nasal congestion* * 2  2/27 (7.41%)  2 2/23 (8.70%)  2 0/39 (0.00%)  0
Nasal congestion+  2  1/27 (3.70%)  2 3/23 (13.04%)  9 9/39 (23.08%)  390
Nasal pruritus+  2  0/27 (0.00%)  0 0/23 (0.00%)  0 2/39 (5.13%)  2
Oropharyngeal discomfort+  3  7/27 (25.93%)  39 12/23 (52.17%)  166 24/39 (61.54%)  394
Oropharyngeal pain* * 2  2/27 (7.41%)  2 1/23 (4.35%)  3 3/39 (7.69%)  3
Rhinorrhoea* * 2  1/27 (3.70%)  1 2/23 (8.70%)  2 0/39 (0.00%)  0
Sneezing+  1  4/27 (14.81%)  20 3/23 (13.04%)  4 17/39 (43.59%)  59
Throat irritation+  1  0/27 (0.00%)  0 0/23 (0.00%)  0 2/39 (5.13%)  19
Wheezing* * 2  1/27 (3.70%)  1 1/23 (4.35%)  1 2/39 (5.13%)  2
Wheezing+  2  0/27 (0.00%)  0 2/23 (8.70%)  3 5/39 (12.82%)  18
Rhinitis allergic * 2  0/27 (0.00%)  0 2/23 (8.70%)  2 0/39 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dermatitis atopic*  2  3/27 (11.11%)  3 0/23 (0.00%)  0 0/39 (0.00%)  0
Eczema* * 2  1/27 (3.70%)  1 2/23 (8.70%)  2 2/39 (5.13%)  2
Eczema+  1  2/27 (7.41%)  2 1/23 (4.35%)  24 0/39 (0.00%)  0
Pruritus+  1  6/27 (22.22%)  30 4/23 (17.39%)  22 20/39 (51.28%)  368
Rash papular*  2  0/27 (0.00%)  0 0/23 (0.00%)  0 2/39 (5.13%)  2
Rash*  2  2/27 (7.41%)  2 3/23 (13.04%)  3 1/39 (2.56%)  1
Rash+  1  1/27 (3.70%)  1 2/23 (8.70%)  182 5/39 (12.82%)  29
Urticaria+  1  9/27 (33.33%)  31 11/23 (47.83%)  107 17/39 (43.59%)  58
Vascular disorders       
Flushing+  2  3/27 (11.11%)  16 4/23 (17.39%)  5 10/39 (25.64%)  24
1
Term from vocabulary, MedDRA (21.1)
2
Term from vocabulary, MedDRA (20.0)
3
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Hugh A. Sampson
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-659-9426
EMail: hugh.sampson@mssm.edu
Layout table for additonal information
Responsible Party: Hugh A Sampson, MD, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01846208    
Other Study ID Numbers: GCO 04-1271
U19AI066738 ( U.S. NIH Grant/Contract )
CoFAR7 ( Other Identifier: Consortium of Food Allergy Research )
First Submitted: April 30, 2013
First Posted: May 3, 2013
Results First Submitted: September 24, 2018
Results First Posted: October 30, 2018
Last Update Posted: July 26, 2019