CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,425 enrolled
Drug / intervention
Insect Venomdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04269629
NCT04269629N/ACompleted

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

Medical University of Graz·observational·Posted Feb 17, 2020·Updated Nov 20, 2020

In Brief

An observational study evaluating Insect Venom for Hymenoptera Venom Allergy and Antihypertensive Treatment. Completed, enrolled 1,425 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesAustria
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 17, 2020
Enrollment StartAug 1, 2014
Primary CompletionJan 1, 2018
Study CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 6.4 years ago

Interventions

Insect Venomdrug

Patients receive insect venom immunotherapy. The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs.