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Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa (T502)

Primary Purpose

Immune System Diseases

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
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
Sponsored by
Inmunotek S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Immune System Diseases focused on measuring Immune System Diseases, Prick Test, Betula verrucosa

Eligibility Criteria

5 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Lucus Augusti

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Allergic patients to birch pollen

Non-allergic patients to birch pollen

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 17, 2015
Last Updated
May 4, 2022
Sponsor
Inmunotek S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT02527187
Brief Title
Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa
Acronym
T502
Official Title
Extract Allergen From Betula Verrucosa. Test Sensitivity and Specificity of Diagnostic in Prick Test Preparation.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inmunotek S.L.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune System Diseases
Keywords
Immune System Diseases, Prick Test, Betula verrucosa

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allergic patients to birch pollen
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-allergic patients to birch pollen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
10 HEP/mL Betula verrucosa allergen extract
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
25 HEP/mL Betula verrucosa allergen extract
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
50 HEP/mL Betula verrucosa allergen extract
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
100 HEP/mL Betula verrucosa allergen extract
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity for 100 HEP/mL
Description
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
Title
Sensitivity for 50 HEP/mL
Description
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
Title
Sensitivity for 25 HEP/mL
Description
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
Title
Sensitivity for 10 HEP/mL
Description
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
Title
Specificity for 100 HEP/mL
Description
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
Title
Specificity for 50 HEP/mL
Description
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
Title
Specificity for 25 HEP/mL
Description
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
Title
Specificity for 10 HEP/mL
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Boquete, MD
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Lucus Augusti
City
Lugo
State/Province
Galicia
ZIP/Postal Code
27003
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa

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