Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa

NCT ID: NCT02527187

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-11-30

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.

Conditions

Immune System Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

10 HEP/mL Betula verrucosa allergen extract

Intervention Type: 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.

25 HEP/mL Betula verrucosa allergen extract

Intervention Type: 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.

50 HEP/mL Betula verrucosa allergen extract

Intervention Type: 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.

100 HEP/mL Betula verrucosa allergen extract

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

10 HEP/mL Betula verrucosa allergen extract

Intervention Type: 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.

25 HEP/mL Betula verrucosa allergen extract

Intervention Type: 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.

50 HEP/mL Betula verrucosa allergen extract

Intervention Type: 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.

100 HEP/mL Betula verrucosa allergen extract

Intervention Type: 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.

Interventions

10 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.

Intervention Type: BIOLOGICAL

25 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.

Intervention Type: BIOLOGICAL

50 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.

Intervention Type: BIOLOGICAL

100 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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inmunotek S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manuel Boquete, MD

Role: STUDY_DIRECTOR

Locations

Hospital Lucus Augusti

Lugo, Galicia, Spain

Countries

Spain

Other Identifiers

2013-005368-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

T502-SSP-007

Identifier Type: -

Identifier Source: org_study_id