Trial Outcomes & Findings for Treatment of Egg Allergy in Children Through Oral Desensitization (EGG OIT) (NCT NCT00597558)

Last Updated: 2018-03-26

Results Overview

Subjects will have a double-blind, placebo-controlled food challenge (DBPCFC) to egg after at least 24 months of egg OIT when the IgE to egg is \< 7 kU/L or 90% of entry level IgE or SPT \<= 5mm with a maximum treatment period of 60 months.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

24-60 months

Results posted on

2018-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	Egg White Protein Powder Egg allergic subjects who ingest oral egg white protein for desensitization and possible tolerance.
Overall Study STARTED	13
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Egg Allergy in Children Through Oral Desensitization (EGG OIT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Egg White Protein Powder n=13 Participants Egg allergic subjects who ingest oral egg white protein for desensitization and possible tolerance.
Age, Continuous	6.6 years n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants

PRIMARY outcome

Timeframe: 24-60 months

Outcome measures

Outcome measures
Measure	Egg White Protein Powder n=9 Participants Egg allergic subjects who ingest oral egg white protein
Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg	9 subjects with no symptoms on DBPCFC

SECONDARY outcome

Timeframe: 24-60 months

Wheal size on egg protein skin prick test at the end of egg OIT treatment compared with at baseline.

Outcome measures

Outcome measures
Measure	Egg White Protein Powder n=9 Participants Egg allergic subjects who ingest oral egg white protein
Egg Protein Skin Prick Test After Egg OIT	1.8 mm Interval 0.0 to 9.0

SECONDARY outcome

Timeframe: 24-60 months

Measure of serum CAP-FEIA to egg from subjects on egg OIT after completion of treatment compared to baseline

Outcome measures

Outcome measures
Measure	Egg White Protein Powder n=9 Participants Egg allergic subjects who ingest oral egg white protein
Serum CAP-FEIA to Egg	4.7 ku/L Interval 0.35 to 8.4

Adverse Events

Egg White Protein Powder

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Egg White Protein Powder n=13 participants at risk Egg allergic subjects who ingest oral egg white protein
Skin and subcutaneous tissue disorders Erythematous rash	46.2% 6/13 • 24-60 months
Skin and subcutaneous tissue disorders Skin itch	7.7% 1/13 • 24-60 months
Skin and subcutaneous tissue disorders Hives	23.1% 3/13 • 24-60 months
Skin and subcutaneous tissue disorders Lip or eye swelling	7.7% 1/13 • 24-60 months
Gastrointestinal disorders Abdominal pain	38.5% 5/13 • 24-60 months
Gastrointestinal disorders Vomiting	30.8% 4/13 • 24-60 months
Gastrointestinal disorders Diarrhea	23.1% 3/13 • 24-60 months
Respiratory, thoracic and mediastinal disorders Sneezing	15.4% 2/13 • 24-60 months
Respiratory, thoracic and mediastinal disorders Nasal itch	0.00% 0/13 • 24-60 months
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/13 • 24-60 months
Respiratory, thoracic and mediastinal disorders Rhinorrhea	7.7% 1/13 • 24-60 months
Respiratory, thoracic and mediastinal disorders Oropharyngeal itch	38.5% 5/13 • 24-60 months
Respiratory, thoracic and mediastinal disorders Wheezing	7.7% 1/13 • 24-60 months
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/13 • 24-60 months
Eye disorders Eye itch	7.7% 1/13 • 24-60 months
Eye disorders Eye tearing	0.00% 0/13 • 24-60 months

Additional Information

Dr. Edwin Kim, Director

University of North Carolina at Chapel Hill

Phone: 919-843-9087

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place