Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa

Phase 2

Completed

• Conditions: Immune System Diseases
• Interventions: 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

• Registration Number: NCT02527187
• Lead Sponsor: Inmunotek S.L.

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.

Study Timeline

• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-18
• Study Start: 2015-09
• Primary Completion: 2016-04
• Study Completion: 2016-11
• Results First Submitted: 2020-06-10
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-04
• Last Update Submitted: 2022-05-04
• Results First Posted: 2022-05-05
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-allergic patients to birch pollen	10 HEP/mL Betula verrucosa allergen extract	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.
Allergic patients to birch pollen	100 HEP/mL Betula verrucosa allergen extract	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.
Non-allergic patients to birch pollen	100 HEP/mL Betula verrucosa allergen extract	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.
Allergic patients to birch pollen	10 HEP/mL Betula verrucosa allergen extract	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.
Allergic patients to birch pollen	25 HEP/mL Betula verrucosa allergen extract	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.
Non-allergic patients to birch pollen	50 HEP/mL Betula verrucosa allergen extract	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.
Allergic patients to birch pollen	50 HEP/mL Betula verrucosa allergen extract	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.
Non-allergic patients to birch pollen	25 HEP/mL Betula verrucosa allergen extract	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.

Primary Outcome Measures

Name	Time	Method
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.
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 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
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
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 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.

Trial Locations

Locations (1)

Hospital Lucus Augusti; 🇪🇸 Lugo, Galicia, Spain