Immune System DiseasesPhase 2T502NCT02527187
Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa
A Phase 2 study testing 10 HEP/mL Betula verrucosa allergen extract, 25 HEP/mL Betula verrucosa allergen extract and 50 HEP/mL Betula verrucosa allergen extract in people with Immune System Diseases, run by Inmunotek S.L. at 1 site in Spain.
Trial summary
The main objective is to evaluate the concentration of allergen extract of Betula verrucosa that elicit a papule equivalent to that produced by a solution of histamine dihydrochloride 10 mg / ml in size. Read more about this study
- Who is it for?
- Ages 5 to 70 years
- Conditions the study is for
- Immune System Diseases
- What is being tested?
- 10 HEP/mL Betula verrucosa allergen extract, 25 HEP/mL Betula verrucosa allergen extract and 50 HEP/mL Betula verrucosa allergen extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to Nov 2016
- Phase
- Phase 2
- 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 5 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients that were using drugs that may interfere with the skin prick tests.
- Patients using the following drugs 24 hours before the test: theophylline, systemic corticosteroids.
- Patients in which the largest diameter of the wheal induced by the positive control was < 3 mm.
- Patients in which the largest diameter of the wheal induced by the negative control was ≥ 3 mm.
- Pregnancy, dermographism, atopic dermatitis (locally at the test site), urticaria.
- Patients who suffer disease in which the use of adrenaline is not allowed.
Show all 11Show fewer
- Patients with any severe psychiatric disease.
- For the patients CH+:
- Patients that received or are treated with immunotherapy with an allergenic extract of birch pollen and/or with allergen extracts with known cross-reactivity to birch pollen (Corylus avellana, Quercus verrucosa, Fagus sylvatica, Castanea satavia, Carpinus betelus and Alnus glutinosa).
- For the patients CH-:
- Patients sensitized to pollen with demonstrated cross-reactivity with the pollen of Betula verrucosa. These pollen included Corylus avellana, Quercus verrucosa, Fagus sylvatica, Castanea satavia, Carpinus betelus and Alnus glutinosa.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extract Allergen From Betula Verrucosa. Test Sensitivity and Specificity of Diagnostic in Prick Test Preparation.
The main objective is to evaluate the concentration of allergen extract of Betula verrucosa that elicit a papule equivalent to that produced by a solution of histamine dihydrochloride 10 mg / ml in size.
Read the detailed description
Open, prospective, unblinded and non-randomized biological assay. Each patient was tested with four concentrations of allergen and with a histamine and saline solution as positive and negative controls, respectively.
- Conditions
- Immune System Diseases
- Being tested
- 10 HEP/mL Betula verrucosa allergen extract, 25 HEP/mL Betula verrucosa allergen extract, 50 HEP/mL Betula verrucosa allergen extract, 100 HEP/mL Betula verrucosa allergen extract
- Keywords
- Immune System Diseases, Prick Test, Betula verrucosa
- Medical subject headings
- Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 HEP/mL Betula verrucosa allergen extractBiological
The investigational product contained 10 HEP/mL Betula verrucosa allergen extract and was tested by administration onto skin. The test was carried out on the forearm following prick test technique.
25 HEP/mL Betula verrucosa allergen extractBiological
The investigational product contained 25 HEP/mL Betula verrucosa allergen extract and was tested by administration onto skin. The test was carried out on the forearm following prick test technique.
50 HEP/mL Betula verrucosa allergen extractBiological
The investigational product contained 50 HEP/mL Betula verrucosa allergen extract and was tested by administration onto skin. The test was carried out on the forearm following prick test technique.
100 HEP/mL Betula verrucosa allergen extractBiological
The investigational product contained 100 HEP/mL Betula verrucosa allergen extract and was tested by administration onto skin. The test was carried out on the forearm following prick test technique.
| Study group | Role | What they receive |
|---|---|---|
| Allergic patients to birch pollen | Experimental | Allergic patients already diagnosed to be "true allergic" to birch pollen.
A mean wheal diameter >3 mm obtained in a prick test with histamine dihydrochloride 10 mg/ml.Also presence of serum specific IgE and clinical history of symptomatology related to exposure to birch pollen.
Patients of both gender aged from 5 up to 70 years. Receives: Biological: 10 HEP/mL Betula verrucosa allergen extract; Biological: 25 HEP/mL Betula verrucosa allergen extract; Biological: 50 HEP/mL Betula verrucosa allergen extract; Biological: 100 HEP/mL Betula verrucosa allergen extract |
| Non-allergic patients to birch pollen | Experimental | Patients already diagnosed to be "true non-allergic" to birch pollen.
Non clinical history of symptomatology related to the exposure to birch pollen. Previous skin prick test negative and absence or undetectable serum specific IgE to Betula verrucosa
Patients of both gender aged from 5 up to 70 years. Receives: Biological: 10 HEP/mL Betula verrucosa allergen extract; Biological: 25 HEP/mL Betula verrucosa allergen extract; Biological: 50 HEP/mL Betula verrucosa allergen extract; Biological: 100 HEP/mL Betula verrucosa allergen extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for 100 HEP/mL
Sensitivity for 100 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test.
It is the proportion of positives that are correctly identified by the test.
Sensitivity: True positives/Total disease
Measured: 1 hour
Sensitivity for 50 HEP/mL
Sensitivity for 50 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test.
It is the proportion of positives that are correctly identified by the test.
Sensitivity: True positives/Total disease
Measured: 1 hour
Sensitivity for 25 HEP/mL
Sensitivity for 25 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test.
It is the proportion of positives that are correctly identified by the test.
Sensitivity: True positives/Total disease
Measured: 1 hour
Sensitivity for 10 HEP/mL
Sensitivity for 10 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test.
It is the proportion of positives that are correctly identified by the test.
Sensitivity: True positives/Total disease
Measured: 1 hour
Specificity for 100 HEP/mL
Specificity for 100 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test.
It is the proportion of negatives that are correctly identified by the test.
Specificity: True negatives/Total no disease.
Measured: 1 hour
Specificity for 50 HEP/mL
Specificity for 50 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test.
It is the proportion of negatives that are correctly identified by the test.
Specificity: True negatives/Total no disease.
Measured: 1 hour
Specificity for 25 HEP/mL
Specificity for 25 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test.
It is the proportion of negatives that are correctly identified by the test.
Specificity: True negatives/Total no disease.
Measured: 1 hour
Specificity for 10 HEP/mL
Specificity for 10 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test.
It is the proportion of negatives that are correctly identified by the test.
Specificity: True negatives/Total no disease.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2016
- Study completionNov 2016
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.
- Other trials for Immune System DiseasesStudies of the same condition, open and under way.
- More trials run by Inmunotek S.L.The 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inmunotek S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manuel Boquete, MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527187
- Sponsor's protocol ID
- T502-SSP-007
- Other IDs
- 2013-005368-24
- Acronym
- T502
- Status last verified
- May 2022
- First submitted
- 17 Aug 2015
- Last updated
- 5 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extract Allergen From Betula Verrucosa. Test Sensitivity and Specificity of Diagnostic in Prick Test Preparation.
- ClinicalTrials.gov ID
- NCT02527187
- Acronym / sponsor ID
- T502 / T502-SSP-007
- Conditions
- Immune System Diseases
- Keywords
- Immune System Diseases, Prick Test, Betula verrucosa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Inmunotek S.L.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Posted 5 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to evaluate the concentration of allergen extract of Betula verrucosa that elicit a papule equivalent to that produced by a solution of histamine dihydrochloride 10 mg / ml in size.
Detailed description
Open, prospective, unblinded and non-randomized biological assay. Each patient was tested with four concentrations of allergen and with a histamine and saline solution as positive and negative controls, respectively.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allergic patients to birch pollen | Experimental | Biological: 10 HEP/mL Betula verrucosa allergen extract, Biological: 25 HEP/mL Betula verrucosa allergen extract, Biological: 50 HEP/mL Betula verrucosa allergen extract, Biological: 100 HEP/mL Betula verrucosa allergen extractAllergic patients already diagnosed to be "true allergic" to birch pollen. A mean wheal diameter >3 mm obtained in a prick test with histamine dihydrochloride 10 mg/ml.Also presence of serum specific IgE and clinical history of symptomatology related to exposure to birch pollen. Patients of both gender aged from 5 up to 70 years. |
| Non-allergic patients to birch pollen | Experimental | Biological: 10 HEP/mL Betula verrucosa allergen extract, Biological: 25 HEP/mL Betula verrucosa allergen extract, Biological: 50 HEP/mL Betula verrucosa allergen extract, Biological: 100 HEP/mL Betula verrucosa allergen extractPatients already diagnosed to be "true non-allergic" to birch pollen. Non clinical history of symptomatology related to the exposure to birch pollen. Previous skin prick test negative and absence or undetectable serum specific IgE to Betula verrucosa Patients of both gender aged from 5 up to 70 years. |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Patients that were using drugs that may interfere with the skin prick tests.
- Patients using the following drugs 24 hours before the test: theophylline, systemic corticosteroids.
- Patients in which the largest diameter of the wheal induced by the positive control was < 3 mm.
- Patients in which the largest diameter of the wheal induced by the negative control was ≥ 3 mm.
- Pregnancy, dermographism, atopic dermatitis (locally at the test site), urticaria.
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 |
|---|---|---|
| 10 HEP/mL Betula verrucosa allergen extractThe investigational product contained 10 HEP/mL Betula verrucosa allergen extract and was tested by administration onto skin. The test was carried out on the forearm following prick test technique. | Biological | Allergic patients to birch pollen, Non-allergic patients to birch pollen |
| 25 HEP/mL Betula verrucosa allergen extractThe investigational product contained 25 HEP/mL Betula verrucosa allergen extract and was tested by administration onto skin. The test was carried out on the forearm following prick test technique. | Biological | Allergic patients to birch pollen, Non-allergic patients to birch pollen |
| 50 HEP/mL Betula verrucosa allergen extractThe investigational product contained 50 HEP/mL Betula verrucosa allergen extract and was tested by administration onto skin. The test was carried out on the forearm following prick test technique. | Biological | Allergic patients to birch pollen, Non-allergic patients to birch pollen |
| 100 HEP/mL Betula verrucosa allergen extractThe investigational product contained 100 HEP/mL Betula verrucosa allergen extract and was tested by administration onto skin. The test was carried out on the forearm following prick test technique. | Biological | Allergic patients to birch pollen, Non-allergic patients to birch pollen |
Primary outcome
Sensitivity for 100 HEP/mL
Time frame: 1 hour
Sensitivity for 100 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of positives that are correctly identified by the test. Sensitivity: True positives/Total disease
Sensitivity for 50 HEP/mL
Time frame: 1 hour
Sensitivity for 50 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of positives that are correctly identified by the test. Sensitivity: True positives/Total disease
Sensitivity for 25 HEP/mL
Time frame: 1 hour
Sensitivity for 25 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of positives that are correctly identified by the test. Sensitivity: True positives/Total disease
Sensitivity for 10 HEP/mL
Time frame: 1 hour
Sensitivity for 10 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of positives that are correctly identified by the test. Sensitivity: True positives/Total disease
Specificity for 100 HEP/mL
Time frame: 1 hour
Specificity for 100 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of negatives that are correctly identified by the test. Specificity: True negatives/Total no disease.
Specificity for 50 HEP/mL
Time frame: 1 hour
Specificity for 50 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of negatives that are correctly identified by the test. Specificity: True negatives/Total no disease.
Specificity for 25 HEP/mL
Time frame: 1 hour
Specificity for 25 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of negatives that are correctly identified by the test. Specificity: True negatives/Total no disease.
Specificity for 10 HEP/mL
Time frame: 1 hour
Specificity for 10 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of negatives that are correctly identified by the test. Specificity: True negatives/Total no disease.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Manuel Boquete, MD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10 HEP/mL Betula verrucosa allergen extract, 25 HEP/mL Betula verrucosa allergen extract and 50 HEP/mL Betula verrucosa allergen extract in people with Immune System Diseases, run by Inmunotek S.L. at 1 site in Spain.
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 0 inclusion and 11 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 5 May 2022. 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 Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2022). 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?
Sensitivity for 100 HEP/mL (time frame: 1 hour). The study lists 8 primary outcomes in all. 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 5 May 2022.