Trial Outcomes & Findings for Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa (NCT NCT02527187)

NCT ID: NCT02527187

Last Updated: 2022-05-05

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 201 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2022-05-05

Participant Flow

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

Participant milestones

Measure	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.	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.
Overall Study STARTED	75	126
Overall Study COMPLETED	75	126
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa

Baseline characteristics by cohort

Measure	Allergic Patients to Birch Pollen n=75 Participants 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 n=126 Participants 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.	Total n=201 Participants Total of all reporting groups
Age, Categorical <=18 years	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants	104 Participants n=7 Participants	164 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	38.2 years STANDARD_DEVIATION 15.5 • n=5 Participants	40.8 years STANDARD_DEVIATION 14.3 • n=7 Participants	39.8 years STANDARD_DEVIATION 14.8 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	80 Participants n=7 Participants	122 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	46 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	75 Participants n=5 Participants	126 Participants n=7 Participants	201 Participants n=5 Participants
Region of Enrollment Spain	75 participants n=5 Participants	126 participants n=7 Participants	201 participants n=5 Participants
positive skin prick test (diameter of the wheal > 3mm)	75 Participants n=5 Participants	126 Participants n=7 Participants	201 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Allergic Patients to Birch Pollen n=75 Participants 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 n=126 Participants 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.
Sensitivity for 100 HEP/mL	75 positive reaction	0 positive reaction

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Allergic Patients to Birch Pollen n=75 Participants 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 n=126 Participants 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.
Sensitivity for 50 HEP/mL	74 positive reaction	0 positive reaction

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Allergic Patients to Birch Pollen n=75 Participants 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 n=126 Participants 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.
Sensitivity for 25 HEP/mL	63 positive reaction	0 positive reaction

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Allergic Patients to Birch Pollen n=75 Participants 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 n=126 Participants 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.
Sensitivity for 10 HEP/mL	58 positive reaction	0 positive reaction

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Allergic Patients to Birch Pollen n=75 Participants 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 n=126 Participants 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.
Specificity for 100 HEP/mL	0 Negative response	126 Negative response

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Allergic Patients to Birch Pollen n=75 Participants 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 n=126 Participants 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.
Specificity for 50 HEP/mL	0 Negative response	126 Negative response

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Allergic Patients to Birch Pollen n=75 Participants 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 n=126 Participants 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.
Specificity for 25 HEP/mL	12 Negative response	126 Negative response

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Allergic Patients to Birch Pollen n=75 Participants 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 n=126 Participants 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.
Specificity for 10 HEP/mL	16 Negative response	126 Negative response

Adverse Events

Allergic Patients to Birch Pollen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-allergic Patients to Birch Pollen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Miguel Casanovas/ Medical Director

Inmunotek

Phone: 91 6510010

Email: mcasanovas@inmunotek.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place