Immune System Diseases
Conditions
Keywords
Immune System Diseases, Prick Test, Betula verrucosa
Brief 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.
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.
Interventions
BIOLOGICAL10 HEP/mL Betula verrucosa allergen extract
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.
BIOLOGICAL25 HEP/mL Betula verrucosa allergen extract
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.
BIOLOGICAL50 HEP/mL Betula verrucosa allergen extract
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.
BIOLOGICAL100 HEP/mL Betula verrucosa allergen extract
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.
Sponsors
Inmunotek S.L.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
General inclusion criteria for both groups: * Positive skin prick test with the positive control (Histamine HCl at 10 mg/mL). The length of the largest diameter of the wheal induced by this control should be ≥ 3 mm. * Negative skin prick test with the negative control. The length of the largest diameter of the wheal induced by this control should be \< 3 mm. * All ages and both genders. For the group of patients CH+ (true positive to Betula verrucosa): All these patients had a previous diagnosis of allergy to the birch pollen: * A positive case history with inhalant allergy related to exposure to birch pollen. * A positive skin prick test (mean wheal diameter ≥ 3 mm) when tested with a biologically standardized extract prepared from birch pollen. This preparation, from another manufacturer, was the one used in the routine in the Hospital. * Positive test for specific IgE (CAP value \> 0.35 IU/mL). For the group of patients CH- (true negative to Betula verrucosa): All these patients had a previous diagnosis of allergy to agents unrelated to birch pollen. * A negative case history with inhalant allergy related to exposure to birch pollen or to pollen with known cross-reactivity with the birch pollen. These patients could be allergic to other pollen or other allergens, such mites. * A negative prick test (largest diameter of the wheal ≥ 3 mm) when tested with a standardized extract prepared from the allergen source in question. * A negative test for specific IgE (CAP value \< 0.35 IU/mL) to birch pollen or to pollen with known cross-reactivity with birch pollen: Corylus avellana, Quercus verrucosa, Fagus sylvatica, Castanea satavia, Carpinus betelus and Alnus glutinosa.
Exclusion criteria
for both groups: * 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity for 100 HEP/mL | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
Spain
Participant flow
Recruitment details
Screening based on subjects already diagnosed as allergic or not to birch pollen. (See Inclusion criteria section)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 75 |
| 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. | 126 |
| Total | 201 |
Baseline characteristics
| Characteristic | Allergic Patients to Birch Pollen | Non-allergic Patients to Birch Pollen | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 12 Participants | 22 Participants |
| Age, Categorical >=65 years | 5 Participants | 10 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 104 Participants | 164 Participants |
| Age, Continuous | 38.2 years STANDARD_DEVIATION 15.5 | 40.8 years STANDARD_DEVIATION 14.3 | 39.8 years STANDARD_DEVIATION 14.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 75 Participants | 126 Participants | 201 Participants |
| positive skin prick test (diameter of the wheal > 3mm) | 75 Participants | 126 Participants | 201 Participants |
| Region of Enrollment Spain | 75 participants | 126 participants | 201 participants |
| Sex: Female, Male Female | 42 Participants | 80 Participants | 122 Participants |
| Sex: Female, Male Male | 33 Participants | 46 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 126 |
| other Total, other adverse events | 0 / 75 | 0 / 126 |
| serious Total, serious adverse events | 0 / 75 | 0 / 126 |
Outcome results
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
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Allergic Patients to Birch Pollen | Sensitivity for 100 HEP/mL | 75 positive reaction |
| Non-allergic Patients to Birch Pollen | Sensitivity for 100 HEP/mL | 0 positive reaction |
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
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Allergic Patients to Birch Pollen | Sensitivity for 10 HEP/mL | 58 positive reaction |
| Non-allergic Patients to Birch Pollen | Sensitivity for 10 HEP/mL | 0 positive reaction |
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
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Allergic Patients to Birch Pollen | Sensitivity for 25 HEP/mL | 63 positive reaction |
| Non-allergic Patients to Birch Pollen | Sensitivity for 25 HEP/mL | 0 positive reaction |
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
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Allergic Patients to Birch Pollen | Sensitivity for 50 HEP/mL | 74 positive reaction |
| Non-allergic Patients to Birch Pollen | Sensitivity for 50 HEP/mL | 0 positive reaction |
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.
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Allergic Patients to Birch Pollen | Specificity for 100 HEP/mL | 0 Negative response |
| Non-allergic Patients to Birch Pollen | Specificity for 100 HEP/mL | 126 Negative response |
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.
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Allergic Patients to Birch Pollen | Specificity for 10 HEP/mL | 16 Negative response |
| Non-allergic Patients to Birch Pollen | Specificity for 10 HEP/mL | 126 Negative response |
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.
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Allergic Patients to Birch Pollen | Specificity for 25 HEP/mL | 12 Negative response |
| Non-allergic Patients to Birch Pollen | Specificity for 25 HEP/mL | 126 Negative response |
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.
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Allergic Patients to Birch Pollen | Specificity for 50 HEP/mL | 0 Negative response |
| Non-allergic Patients to Birch Pollen | Specificity for 50 HEP/mL | 126 Negative response |