Hymenoptera Venom AllergyEADOASNCT04269629
The Effect of Antihypertensive Drugs on Severity of Anaphylaxis and Side-effects During Venom Immunotherapy
An observational study of Hymenoptera Venom Allergy and Antihypertensive Treatment, run by Medical University of Graz at 1 site in Austria.
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). Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Hymenoptera Venom Allergy, Antihypertensive Treatment
- What is being tested?
- Insect Venom
- How many people
- 1,425 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2014to Mar 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with a history of anaphylactic sting reaction
Who may be able to join
- History of systemic sting reaction (≥ grade I according the classification by Ring and Messmer)
- age 35 to 85 years
Who cannot join
- absolute contraindications for VIT
- pretreatment with Omalizumab
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Dermatology and Venerology, Medical University of Graz
Graz, 8036
About this study
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.
- Being tested
- Insect Venom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| patients with a history of an anaphylactic sting reaction | 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. Receives: Drug: Insect Venom |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (8)
Severity of Sting Reactions
To evaluate whether subjects under antihypertensive treatment with beta-blockers and/or ACE-inhibitors have more severe sting reactions.
Measured: duration of first visit (~1hour)
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.
Measured: duration of first visit (~1hour)
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.
Measured: 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
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].
Measured: 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
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
Measured: 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
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.
Measured: depends on the protocol used for venom immunotherapy, a maximum of about 6 months
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.
Measured: 1 year after reaching the maintenance dose; duration of Visit ~1hour
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..
Measured: duration of Visit ~1hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study startAug 2014
- Primary completionJan 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hymenoptera Venom AllergyStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269629
- Sponsor's protocol ID
- 26-422 ex13/14 (EADOAS)
- Acronym
- EADOAS
- Status last verified
- Oct 2020
- First submitted
- 5 Feb 2020
- Last updated
- 20 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sturm GJ, Herzog SA, Aberer W, Alfaya Arias T, Antolin-Amerigo D, Bonadonna P, Boni E, Bozek A, Chelminska M, Ernst B, Frelih N, Gawlik R, Gelincik A, Hawranek T, Hoetzenecker W, Jimenez Blanco A, Kita K, Kendirlinan R, Kosnik M, Laipold K, Lang R, Marchi F, Mauro M, Nittner-Marszalska M, Poziomkowska-Gesicka I, Pravettoni V, Preziosi D, Quercia O, Reider N, Rosiek-Biegus M, Ruiz-Leon B, Schrautzer C, Serrano P, Sin A, Sin BA, Stoevesandt J, Trautmann A, Vachova M, Arzt-Gradwohl L. beta-blockers and ACE inhibitors are not a risk factor for severe systemic sting reactions and adverse events during venom immunotherapy. Allergy. 2021 Jul;76(7):2166-2176. doi: 10.1111/all.14785. Epub 2021 Mar 11.
PubMed 33605465
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Antihypertensive Drugs on Severity of Anaphylaxis and Side-effects During Venom Immunotherapy
- ClinicalTrials.gov ID
- NCT04269629
- Acronym / sponsor ID
- EADOAS / 26-422 ex13/14 (EADOAS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,425 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Posted 20 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with a history of an anaphylactic sting reaction | – | Drug: Insect VenomAt 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. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a history of anaphylactic sting reaction
Key inclusion criteria (2 listed)
- History of systemic sting reaction (≥ grade I according the classification by Ring and Messmer)
- age 35 to 85 years
Key exclusion criteria (2 listed)
- absolute contraindications for VIT
- pretreatment with Omalizumab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insect VenomPatients 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. | Drug | patients with a history of an anaphylactic sting reaction |
Primary outcome
Frequency of Side Effects (=Systemic Reaction, SR) During Venom Immunotherapy (VIT)
Time frame: 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
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.
8 secondary outcomes
Severity of Sting Reactions
Time frame: duration of first visit (~1hour)
Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Severe Systemic Sting Reactions.
Time frame: duration of first visit (~1hour)
Association of Bee Venom With a Higher Frequency of Side-effects (=Systemic Reaction, SR).
Time frame: 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
Correlation of High Specific Immunoglobulin E (sIgE) Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR).
Time frame: 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
Correlation of High Tryptase Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR).
Time frame: 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
Correlation of Quicker Up-dosing Protocols to a Higher Frequency of Side-effects (=Systemic Reaction, SR).
Time frame: depends on the protocol used for venom immunotherapy, a maximum of about 6 months
Efficacy of VIT
Time frame: 1 year after reaching the maintenance dose; duration of Visit ~1hour
Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Frequent Side Effects (=Systemic Reaction, SR) Under VIT.
Time frame: duration of Visit ~1hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33605465Sturm GJ, Herzog SA, Aberer W, Alfaya Arias T, Antolin-Amerigo D, Bonadonna P, Boni E, Bozek A, Chelminska M, Ernst B, Frelih N, Gawlik R, Gelincik A, Hawranek T, Hoetzenecker W, Jimenez Blanco A, Kita K, Kendirlinan R, Kosnik M, Laipold K, Lang R, Marchi F, Mauro M, Nittner-Marszalska M, Poziomkowska-Gesicka I, Pravettoni V, Preziosi D, Quercia O, Reider N, Rosiek-Biegus M, Ruiz-Leon B, Schrautzer C, Serrano P, Sin A, Sin BA, Stoevesandt J, Trautmann A, Vachova M, Arzt-Gradwohl L. beta-blockers and ACE inhibitors are not a risk factor for severe systemic sting reactions and adverse events during venom immunotherapy. Allergy. 2021 Jul;76(7):2166-2176. doi: 10.1111/all.14785. Epub 2021 Mar 11.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hymenoptera Venom Allergy and Antihypertensive Treatment, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Side Effects (=Systemic Reaction, SR) During Venom Immunotherapy (VIT) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04269629, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.