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

Hymenoptera Venom Allergy Clinical Trial

— EADOAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04269629
• Other study ID #: 26-422 ex13/14 (EADOAS)
• Status: Completed
• Start date: August 2014
• Est. completion date: March 2019

Study information

• Verified date: October 2020
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1425
• Est. completion date: March 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anaphylaxis
• Antihypertensive Treatment
• Hymenoptera Venom Allergy

Intervention

Drug:
• Insect Venom
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.

Locations

Country	Name	City	State
Austria	Department of Dermatology and Venerology, Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Side Effects (=Systemic Reaction, SR) During Venom Immunotherapy (VIT)	The primary objective of this study is to evaluate whether subjects under antihypertensive treatment with beta-blockers and/or angiotensin converting enzyme (ACE)-inhibitors show more side effects during VIT compared to subjects with no antihypertensive treatment.	after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour
Secondary	Severity of Sting Reactions	To evaluate whether subjects under antihypertensive treatment with beta-blockers and/or ACE-inhibitors have more severe sting reactions.	duration of first visit (~1hour)
Secondary	Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Severe Systemic Sting Reactions.	To correlate the prevalence of cardiovascular diseases and/or hypertension with the risk for more severe systemic sting reactions.	duration of first visit (~1hour)
Secondary	Association of Bee Venom With a Higher Frequency of Side-effects (=Systemic Reaction, SR).	To evaluate whether bee venom is associated with a higher frequency of side-effects.	after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour
Secondary	Correlation of High Specific Immunoglobulin E (sIgE) Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR).	To evaluate whether high specific immunoglobulin E (sIgE) levels are correlated to a higher frequency of side-effects.; sIgE levels are expressed in kilo units/liter [kU/L].	after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour
Secondary	Correlation of High Tryptase Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR).	To evaluate whether high tryptase levels are correlated to a higher frequency of side-effects	after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour
Secondary	Correlation of Quicker Up-dosing Protocols to a Higher Frequency of Side-effects (=Systemic Reaction, SR).	To evaluate whether quicker up-dosing protocols are correlated to a higher frequency of side-effects.	depends on the protocol used for venom immunotherapy, a maximum of about 6 months
Secondary	Efficacy of VIT	The outcome (systemic reaction to sting or not) of sting challenges and/or field stings will be recorded to identify patients who will not tolerate but react to future stings. These results will be compared between patients not taking antihypertensive (AHT) drugs and patients taking AHT drugs.	1 year after reaching the maintenance dose; duration of Visit ~1hour
Secondary	Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Frequent Side Effects (=Systemic Reaction, SR) Under VIT.	To correlate the prevalence of cardiovascular diseases and/or hypertension with the risk for more frequent side effects (=systemic reaction, SR) under VIT..	duration of Visit ~1hour