Background Placebo control in allergen immunotherapy (AIT) trials presents ethical and blinding concerns. We tested a trial design with an “active allergen placebo,” as proposed by ARIA‐GA2LEN, to investigate in a double‐blind trial the efficacy and safety of AIT in dual‐allergic patients (grass and birch pollen) using active untargeted treatments as controls. Methods We randomized 95 patients to receive either grass (N = 47) or birch AIT (N = 48). Patients were exposed to both allergens in an allergen challenge chamber (ACC) before and after 9 months of AIT. Targeted (ACC‐allergen = AIT‐allergen) and untargeted (ACC‐allergen ≠ AIT‐allergen) treatment effects were assessed. Results Immunotherapy reduced significantly the mean (95% confidence interval) area under the curve of total nasal symptom score (targeted effects) by −13.55 (−17.56, −9.54; P < 0.001) after grass and −9.81 (−14.13, −5.50; P < 0.001) after birch AIT. Differences in targeted vs untargeted effects between AIT groups (utility of control group) were statistically significant for both grass (P = 0.02) and birch (P = 0.02) allergens. Targeted vs untargeted differences within‐treatment groups (specificity of ACC measurement) were significant for grass AIT (P < 0.001) but not significant for birch AIT group (P = 0.24). Specific immunoglobulin G4 to both allergens increased significantly (P < 0.001) after targeted treatment, while remained unchanged for untargeted treatments. Both treatments were well tolerated. Conclusions Immunotherapies for both grass and birch allergens were efficacious and safe. The study confirms the specificity of AIT. Untargeted treatment groups could serve as controls in future AIT trials.

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Our study suggests poor adherence in patients and caregivers to anaphylaxis guidelines recommending more than 1 EAI available at all times and implies that this can result in adverse outcomes.

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RATIONALE: Food allergy affects 3-6% of school age children. Consensus guidelines on the management of food allergy in the school setting recommend food allergic students have an individualized emergency care plan (ECP) as well as epinephrine available at all times. This study examined whether food allergic children (K-12) had ECPs and epinephrine at school. METHODS: Data regarding ECPs, epinephrine auto injectors, and type of food allergies was collected for the 2015-2016 school year from the school nurses at each school in the district. RESULTS: Data was available for 5,015 of 5,738 students in the district. 418 (8.33%) students reported food allergies. From kindergarten through 7th grade, the percentage of students with ECPs was 71.8% (171/238), and the percentage of students with epinephrine auto-injectors was 83.6% (199/ 238). From 8-12 grade, the rate of students with ECPs decreased to 5.0% (9/ 180), and the rate of epinephrine auto-injectors decreased to 47.2% (85/ 180). These figures accounted for students who had documentation of permission to self-carry epinephrine in the district, including grades 8-12. CONCLUSIONS: In this suburban school district, there was a significant decrease in the percentage of students with ECPs and epinephrine autoinjectors from grades 8-12 compared to grades K-7. Adolescence and delayed administration of epinephrine are risk factors for poor outcomes from food allergy anaphylaxis. This data highlights a gap in anaphylaxis preparedness in the school setting, and suggests an opportunity for targeted educational efforts towards this high risk population.