Table 7.

Summary of RCTs with hen egg

Study (Author, year, country)	Design	Active group vs comparator	Sample size (AG/CG)	Age (yrs) [mean (range)]	Duration desensitization protocol/maintenance dose	Outcomes: desensitization/sustained unresponsiveness	Discontinued due to AEs	SAEs
Burks, 2012, USA [130]	RCT	OIT vs placebo	40/15	7 (5–11)	22 months/1.6 g DEW	After 22 months, 30 (75%) pts in AG passed 10-g- OFC/at 6–8 weeks later only 11 (28%)	5	No reports of severe or life-threatening symptoms or death
Caminiti, 2015, Italy [131]	DBPCRT	OIT vs placebo	17/14	6 (4–11)	4 months/4 g DEW	AG: 16/17 pts (1 dropout) complete OD/AG: After 3-months-HE-avoidance, 31% of these 16 pts remained tolerant. CG: only 1 pt passed the final OFC.	1	3 SAEs: during OD, 1 pt [withdrawal (U, throat pruritus, R, A, vomiting); during HE-containing diet: 1 pt presented U, abdominal pain after exercise (1 cooked HE) and another wheezing and cough during upper respiratory infection (1 cooked HE). [Both tolerant after 3 months of HE containing diet discontinuation]

A asthma, AE adverse event, AG active group, CG control group, DBPRT Double blind placebo controlled randomized trial, DEW, E epinephrine, HE Hens’ egg, OD Oral desensitization, OFC oral food challenge, OFS oropharyngeal symptoms, OIT Oral immunotherapy, OT Oral tolerance, Pt participant, R rhinitis, RCT randomized controlled trial, SAE severe adverse event, U urticaria, wk week