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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005368-24 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10 HEP/mL Betula verrucosa allergen extract | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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. | 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. |
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General inclusion criteria for both groups:
For the group of patients CH+ (true positive to Betula verrucosa): All these patients had a previous diagnosis of allergy to the birch pollen:
Exclusion criteria for both groups:
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-:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Boquete, MD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Lucus Augusti | Lugo | Galicia | 27003 | Spain |
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Screening based on subjects already diagnosed as allergic or not to birch pollen. (See Inclusion criteria section)
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| ID | Title | Description |
|---|---|---|
| FG000 | Allergic Patients to Birch Pollen | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 25 HEP/mL Betula verrucosa allergen extract | Biological | 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. |
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| 50 HEP/mL Betula verrucosa allergen extract | Biological | 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. |
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| 100 HEP/mL Betula verrucosa allergen extract | Biological | 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. |
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| 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. | 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. | 1 hour |
| FG001 |
| Non-allergic Patients to Birch Pollen |
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. |
| COMPLETED |
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| NOT COMPLETED |
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All patients were included for the analysis and tested with the 4 concentrations of the birch extract, negative and positive controls, and with the birch pollen extract used in normal clinical conditons Skin prick test was considered positive when wheal diameter was >3mm and negative when wheal diameter was < 3 mm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Allergic Patients to Birch Pollen | 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. |
| BG001 | Non-allergic Patients to Birch Pollen | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| positive skin prick test (diameter of the wheal > 3mm) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | positive reaction | 1 hour |
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| Primary | 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 | Posted | Number | positive reaction | 1 hour |
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| Primary | 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 | Posted | Number | positive reaction | 1 hour |
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| Primary | 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 | Posted | Number | positive reaction | 1 hour |
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| Primary | 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. | Posted | Number | Negative response | 1 hour |
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| Primary | 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. | Posted | Number | Negative response | 1 hour |
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| Primary | 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. | Posted | Number | Negative response | 1 hour |
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| Primary | 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. | Posted | Number | Negative response | 1 hour |
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Up to 1 hour after performing test and up to 5 days after release from the hospital.
In terms of safety, although skin prick tests are safe and patients were already tested previously in the hospital, the investigator took special care in order to check for the presence of any unwanted reaction. Patients remained in the hospital facilities (around 30 min-1 hour after test) and were instructed to report, to the investigator, any adverse event occurring after leaving the hospital.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Allergic Patients to Birch Pollen | 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. | 0 | 75 | 0 | 75 | 0 | 75 |
| EG001 | Non-allergic Patients to Birch Pollen | 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. | 0 | 126 | 0 | 126 | 0 | 126 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Miguel Casanovas/ Medical Director | Inmunotek | 91 6510010 | mcasanovas@inmunotek.com |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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