CompletedNCT02527187T502Updated May 5, 2022Results posted

Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa

A Phase 2 interventional study of 10 HEP/mL Betula verrucosa allergen extract and 25 HEP/mL Betula verrucosa allergen extract in Immune System Diseases, sponsored by Inmunotek S.L.. Completed at 1 site in Spain. Open to participants aged 5 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-05.

Sponsored by Inmunotek S.L. · Phase 2, Interventional, and Diagnostic

Phase: Phase 2
Study type: Interventional
Enrollment: 201
Allocation: Non-randomized
Ages: 5 Years to 70 Years
Sex: All

Study 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.

Read the 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 studied

Immune System Diseases

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Immune System Diseases 288

Keywords

Immune System Diseases
Prick Test
Betula verrucosa

In context

Immune System Diseases

288 studies on the registry are indexed under Immune System Diseases; 80 are open to participants now.

This study's enrollment of 201 is above the median of 71 across 194 interventional studies indexed under Immune System Diseases.

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Lead sponsor

Inmunotek S.L. is the lead sponsor of 24 studies on the registry; 11 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 5 Years to 70 Years
Sexes eligible: All
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.

Study design

Phase: Phase 2
Primary purpose: Diagnostic
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 201 participants (actual)

Study arms

Experimental
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.
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
Experimental
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.
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

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.

What researchers measure

Primary outcomes

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
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
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
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
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
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
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
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

Results

Posted May 5, 2022

Participant flow

Screening based on subjects already diagnosed as allergic or not to birch pollen. (See Inclusion criteria section)

Participant flow — Overall Study
Milestone	Allergic Patients to Birch Pollen	Non-allergic Patients to Birch Pollen
Started	75	126
Completed	75	126
Not completed	0	0

Outcome measures

PrimarySensitivity 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
Reported as:: Number · positive reaction

Sensitivity for 100 HEP/mL
positive reaction	Allergic Patients to Birch Pollen	Non-allergic Patients to Birch Pollen
Sensitivity for 100 HEP/mL	75	0

PrimarySensitivity 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
Reported as:: Number · positive reaction

Sensitivity for 50 HEP/mL
positive reaction	Allergic Patients to Birch Pollen	Non-allergic Patients to Birch Pollen
Sensitivity for 50 HEP/mL	74	0

PrimarySensitivity 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
Reported as:: Number · positive reaction

Sensitivity for 25 HEP/mL
positive reaction	Allergic Patients to Birch Pollen	Non-allergic Patients to Birch Pollen
Sensitivity for 25 HEP/mL	63	0

PrimarySensitivity 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
Reported as:: Number · positive reaction

Sensitivity for 10 HEP/mL
positive reaction	Allergic Patients to Birch Pollen	Non-allergic Patients to Birch Pollen
Sensitivity for 10 HEP/mL	58	0

PrimarySpecificity 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
Reported as:: Number · Negative response

Specificity for 100 HEP/mL
Negative response	Allergic Patients to Birch Pollen	Non-allergic Patients to Birch Pollen
Specificity for 100 HEP/mL	0	126

PrimarySpecificity 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
Reported as:: Number · Negative response

Specificity for 50 HEP/mL
Negative response	Allergic Patients to Birch Pollen	Non-allergic Patients to Birch Pollen
Specificity for 50 HEP/mL	0	126

PrimarySpecificity 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
Reported as:: Number · Negative response

Specificity for 25 HEP/mL
Negative response	Allergic Patients to Birch Pollen	Non-allergic Patients to Birch Pollen
Specificity for 25 HEP/mL	12	126

PrimarySpecificity 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
Reported as:: Number · Negative response

Specificity for 10 HEP/mL
Negative response	Allergic Patients to Birch Pollen	Non-allergic Patients to Birch Pollen
Specificity for 10 HEP/mL	16	126

Adverse events

Collected over Up to 1 hour after performing test and up to 5 days after release from the hospital.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Allergic Patients to Birch Pollen	0/75 (0%)	0/75 (0%)	0/75 (0%)
Non-allergic Patients to Birch Pollen	0/126 (0%)	0/126 (0%)	0/126 (0%)

Baseline characteristics

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.

Age, Categorical
Age, Categorical(Participants)	Allergic Patients to Birch Pollen	Non-allergic Patients to Birch Pollen	Total
<=18 years	10	12	22
Between 18 and 65 years	60	104	164
>=65 years	5	10	15

Age, Continuous
Age, Continuous(years)	Allergic Patients to Birch Pollen	Non-allergic Patients to Birch Pollen	Total
Mean	38.2 ± 15.5	40.8 ± 14.3	39.8 ± 14.8

Sex: Female, Male
Sex: Female, Male(Participants)	Allergic Patients to Birch Pollen	Non-allergic Patients to Birch Pollen	Total
Female	42	80	122
Male	33	46	79

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Allergic Patients to Birch Pollen	Non-allergic Patients to Birch Pollen	Total
Hispanic or Latino	0	0	0
Not Hispanic or Latino	0	0	0
Unknown or Not Reported	75	126	201

Region of Enrollment
Region of Enrollment(participants)	Allergic Patients to Birch Pollen	Non-allergic Patients to Birch Pollen	Total
Spain	75	126	201

positive skin prick test (diameter of the wheal > 3mm)
positive skin prick test (diameter of the wheal > 3mm)(Participants)	Allergic Patients to Birch Pollen	Non-allergic Patients to Birch Pollen	Total
Count of participants	75	126	201

Study locations

1 site

Hospital Lucus Augusti
Lugo, Galicia 27003, Spain

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2015, a primary completion of Apr 2016 and a completion of Nov 2016. It does not say whether these dates are actual or estimated.

Results were first posted in May 2022, 6 years 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 17, 2015
First posted: Aug 18, 2015
Start: Sep 2015
Primary completionActual: Apr 2016
CompletionActual: Nov 2016
Results first posted: May 5, 2022
Last update: May 5, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02527187
Lead sponsor: Inmunotek S.L.
Responsible party: Sponsor
First posted: Aug 18, 2015
Start date: Sep 2015
Primary completion: Apr 2016
Completion: Nov 2016
Results posted: May 5, 2022
Last update: May 5, 2022

Study contacts

Manuel Boquete, MD

study director

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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