Birch Pollen AllergyMADMAXNCT04435678
Diagnostic Accuracy of the MADx Multi Array Xplorer (MAX 45k) Automated Laboratory System and the MADx Allergy Explorer Version 2 (ALEX²) - IgE Multiplex Test for the Diagnosis of Pre-defined Groups of Specific High-priority Allergens
A study testing ALEX² test using the MAX 45k automated laboratory system in people with Birch Pollen Allergy and Grass Pollen Allergy, run by MacroArray Diagnostics GmbH at 2 sites in Austria.
Trial summary
About 20% of the general population are affected by an allergy - with an upward trend. Quite often, allergic people do not consider their disease as serious and suffer from subsequent complications, like allergic asthma, later in their life. Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- Birch Pollen Allergy, Grass Pollen Allergy, House Dust Mite Allergy
- What is being tested?
- ALEX² test using the MAX 45k automated laboratory system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 839 participants
- Where
- 2 sitesAustria
- Study dates
- 22 Jul 2020to 12 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 0 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female subjects with suspicion of allergy
- Written consent of the participant (and/or his/her parent or legal representative) after being informed
Who cannot join
- Oral treatment with corticosteroids (>5mg/day)
- Treatment with antihistamines (histamine (H1) receptor blockers)
- Hematological disease (coagulation disorders, anemia)
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Department of Dermatology and Venerology, Medical University of Graz
Graz, 8036
Allergy Outpatient Clinic Reumannplatz
Vienna, 1100
About this study
About 20% of the general population are affected by an allergy - with an upward trend. Quite often, allergic people do not consider their disease as serious and suffer from subsequent complications, like allergic asthma, later in their life. The sooner the allergen source is identified, the sooner the therapeutic intervention (e.g. dietary recommendations, allergen avoidance, anti-inflammatory treatment or allergen immunotherapy) can be started. Cross-reactivity may also play an important role. Therefore, a comprehensive allergy test is essential for an optimal treatment of patients.
Modern multiplex testing is an individualized diagnostic approach, which may help to identify eligible patients for allergen immunotherapy and may identify risk groups by analyzing the sIgE profile. Until now, published data on the clinical usability of multiplex allergy diagnostic test systems are often limited. Even though, available studies show a good correlation between conventionally used multiplex or singleplex assays (ISAC or ImmunoCAP) and the new multiplex assay (ALEX and ALEX²), the results are often based on small sample sizes investigating many different allergens.
Therefore, this clinical performance study is conducted to evaluate the diagnostic accuracy of the ALEX² IgE multiplex test using the Multi Array Explorer (MAX 45k, MacroArray Diagnostics) automated laboratory system in comparison to a conventional IgE singleplex test system as well as clinical symptoms and skin prick test results in a total of 826 patients. Patients with the most common inhalant allergies (e.g. grass pollen, house dust mite or cat allergy) will be included as well as patients suffering from Hymenoptera venom allergy, which is the major cause of anaphylaxis.
- Conditions
- Birch Pollen Allergy, Grass Pollen Allergy, House Dust Mite Allergy, Cat Allergy, Bee Venom Allergy, Vespid Venom Allergy
- Being tested
- ALEX² test using the MAX 45k automated laboratory system
- Medical subject headings
- Dust Mite Allergy, Venom Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALEX² test using the MAX 45k automated laboratory systemDiagnostic test
The ALEX² test system is a quantitative in vitro diagnostic (IVD) test for the measurement of allergen specific IgE (sIgE) and a semi-quantitative in vitro diagnostic test for the measurement of total IgE (tIgE) in human serum or plasma (exception EDTA plasma).
The MAX 45k analyzer is intended for an automated in-vitro diagnostics use for quantitative determination of allergen specific Immunoglobulin E and semi-quantitative determination of total IgE. The MAX 45k is suitable for human serum or plasma (Heparin, Citrat, but no EDTA). MAX 45k is intended to be used only in conjunction with RAPTOR SERVER analysis software and ALEX based technology arrays.
| Study group | Role | What they receive |
|---|---|---|
| birch pollen allergy | Other | 106 patients with suspicion of birch pollen allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed.
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system). Receives: Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system |
| grass pollen allergy | Other | 106 patients with suspicion of grass pollen allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed.
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system). Receives: Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system |
| house dust mite allergy | Other | 148 patients with suspicion of house dust mite allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed.
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system) Receives: Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system |
| cat allergy | Other | 106 patients with suspicion of cat allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed.
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system). Receives: Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system |
| bee venom allergy | Other | 106 patients with suspicion of bee venom allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and an intradermal test will be performed.
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system). Receives: Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system |
| vespid venom allergy | Other | 106 patients with suspicion of vespid venom allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and an intradermal test will be performed.
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system). Receives: Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system |
| non-allergic individuals | Other | 148 non-allergic individuals will be included in the study. They should have no symptoms that could be related to inhalant allergy or Hymenoptera venom allergy, negative skin test results and undetectable IgE levels.
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system). Receives: Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy (sensitivity, specificity) of the MAX 45k/ALEX² IgE multiplex test
Sensitivity and specificity of the sIgE status determined by the MAX 45k/ALEX² IgE multiplex test (positive, if ≥0.30 kUA/L) compared to allergy status according to clinical symptoms.
Measured: 1 day
Secondary outcomes (1)
Skin test
Sensitivity and specificity of the sIgE status determined by the MAX 45k/ALEX² IgE multiplex test compared to allergy status according to skin test results (specific for suspected allergy)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start22 Jul 2020
- Primary completion12 Apr 2022
- Study completion12 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birch Pollen AllergyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 839 participants (actual)
Sponsor and investigators
- Lead sponsor
- MacroArray Diagnostics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435678
- Sponsor's protocol ID
- 32-332 ex 19/20
- Acronym
- MADMAX
- Status last verified
- Feb 2022
- First submitted
- 15 Jun 2020
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of the MADx Multi Array Xplorer (MAX 45k) Automated Laboratory System and the MADx Allergy Explorer Version 2 (ALEX²) - IgE Multiplex Test for the Diagnosis of Pre-defined Groups of Specific High-priority Allergens
- ClinicalTrials.gov ID
- NCT04435678
- Acronym / sponsor ID
- MADMAX / 32-332 ex 19/20
- Conditions
- Birch Pollen Allergy, Grass Pollen Allergy, House Dust Mite Allergy, Cat Allergy, Bee Venom Allergy, Vespid Venom Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 839 participants (actual)
- Lead sponsor
- MacroArray Diagnostics GmbHIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 12 Apr 2022 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
About 20% of the general population are affected by an allergy - with an upward trend. Quite often, allergic people do not consider their disease as serious and suffer from subsequent complications, like allergic asthma, later in their life. The sooner the allergen source is identified, the sooner the therapeutic intervention (e.g. dietary recommendations, allergen avoidance, anti-inflammatory treatment or allergen immunotherapy) can be started. Cross-reactivity may also play an important role. Therefore, a comprehensive allergy test is essential for an optimal treatment of patients.
Modern multiplex testing is an individualized diagnostic approach, which may help to identify eligible patients for allergen immunotherapy and may identify risk groups by analyzing the sIgE profile. Until now, published data on the clinical usability of multiplex allergy diagnostic test systems are often limited. Even though, available studies show a good correlation between conventionally used multiplex or singleplex assays (ISAC or ImmunoCAP) and the new multiplex assay (ALEX and ALEX²), the results are often based on small sample sizes investigating many different allergens.
Therefore, this clinical performance study is conducted to evaluate the diagnostic accuracy of the ALEX² IgE multiplex test using the Multi Array Explorer (MAX 45k, MacroArray Diagnostics) automated laboratory system in comparison to a conventional IgE singleplex test system as well as clinical symptoms and skin prick test results in a total of 826 patients. Patients with the most common inhalant allergies (e.g. grass pollen, house dust mite or cat allergy) will be included as well as patients suffering from Hymenoptera venom allergy, which is the major cause of anaphylaxis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| birch pollen allergy | Other | Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system106 patients with suspicion of birch pollen allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed. Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system). |
| grass pollen allergy | Other | Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system106 patients with suspicion of grass pollen allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed. Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system). |
| house dust mite allergy | Other | Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system148 patients with suspicion of house dust mite allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed. Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system) |
| cat allergy | Other | Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system106 patients with suspicion of cat allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed. Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system). |
| bee venom allergy | Other | Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system106 patients with suspicion of bee venom allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and an intradermal test will be performed. Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system). |
| vespid venom allergy | Other | Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system106 patients with suspicion of vespid venom allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and an intradermal test will be performed. Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system). |
| non-allergic individuals | Other | Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system148 non-allergic individuals will be included in the study. They should have no symptoms that could be related to inhalant allergy or Hymenoptera venom allergy, negative skin test results and undetectable IgE levels. Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system). |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female subjects with suspicion of allergy
- Written consent of the participant (and/or his/her parent or legal representative) after being informed
Key exclusion criteria (3 listed)
- Oral treatment with corticosteroids (>5mg/day)
- Treatment with antihistamines (histamine (H1) receptor blockers)
- Hematological disease (coagulation disorders, anemia)
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 |
|---|---|---|
| ALEX² test using the MAX 45k automated laboratory systemThe ALEX² test system is a quantitative in vitro diagnostic (IVD) test for the measurement of allergen specific IgE (sIgE) and a semi-quantitative in vitro diagnostic test for the measurement of total IgE (tIgE) in human serum or plasma (exception EDTA plasma). The MAX 45k analyzer is intended for an automated in-vitro diagnostics use for quantitative determination of allergen specific Immunoglobulin E and semi-quantitative determination of total IgE. The MAX 45k is suitable for human serum or plasma (Heparin, Citrat, but no EDTA). MAX 45k is intended to be used only in conjunction with RAPTOR SERVER analysis software and ALEX based technology arrays. | Diagnostic test | bee venom allergy, birch pollen allergy, cat allergy, grass pollen allergy, house dust mite allergy, non-allergic individuals, vespid venom allergy |
Primary outcome
diagnostic accuracy (sensitivity, specificity) of the MAX 45k/ALEX² IgE multiplex test
Time frame: 1 day
Sensitivity and specificity of the sIgE status determined by the MAX 45k/ALEX² IgE multiplex test (positive, if ≥0.30 kUA/L) compared to allergy status according to clinical symptoms.
1 secondary outcome
Skin test
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALEX² test using the MAX 45k automated laboratory system in people with Birch Pollen Allergy and Grass Pollen Allergy, run by MacroArray Diagnostics GmbH at 2 sites 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 3 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 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
diagnostic accuracy (sensitivity, specificity) of the MAX 45k/ALEX² IgE multiplex test (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2022.