The Effect of Antihypertensive Drugs on Severity of Anaphylaxis and Side-effects During Venom Immunotherapy (EADOAS)

Medical University of Graz

Status: Completed

Conditions: Hymenoptera Venom Allergy; Antihypertensive Treatment

Treatments: Drug: Insect Venom

Study type: Observational

Funder types: Other

Identifiers

NCT04269629

26-422 ex13/14 (EADOAS)

Details and patient eligibility

About

There is an ongoing debate whether antihypertensive treatment with beta-blockers and/or angiotensin converting Enzyme (ACE)-inhibitors comprises a risk factor for more severe and more frequent side-effects during venom immunotherapy (VIT). In the literature, data are controversial and originate from case reports or statistically underpowered studies; the number of included patients was usually high but the proportion of patients on antihypertensive treatment was low ranging from 2-11%.

The study was conducted as a prospective, observational, European multicenter study. 1425 patients, aged from 35 to 85 years, with a history of an anaphylactic reaction due to bee or wasp stings, were included. The medical history was recorded as well as laboratory parameters and data of the VIT-updosing phase. One year after reaching the maintenance dose, possible side-effects during VIT as well as the outcome of field stings or sting challenges were documented.

Enrollment: 1,425 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of systemic sting reaction (≥ grade I according the classification by Ring and Messmer)
• age 35 to 85 years

Exclusion criteria

• absolute contraindications for VIT
• pretreatment with Omalizumab

Trial design

1,425 participants in 1 patient group

patients with a history of an anaphylactic sting reaction

Description:

At Visit 1, patients will be included after carefully reviewing all inclusion and exclusion criteria. All data concerning the index sting, laboratory parameters like immunoglobulin E (IgE) and tryptase levels and skin test results will be recorded as well as the concomitant diseases and medication. Visit 2 will be performed after VIT updosing is finished. At this Visit data concerning the immunotherapy - premedication, preparation, updosing protocol, the outcome of possible large, local reactions (LLR) and systemic reactions (SR) and changes in diseases and medication will be recorded. One year after reaching the maintenance dose, Visit 3 will be performed. At this Visit data concerning the maintenance phase like premedication and possible side effects will be recorded as well as the outcome of insect stings.

Treatment:

Drug: Insect Venom