Phase 2
N=201
Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa
Immune System Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02527187 ↗Enrolled (actual)
201
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Sensitivity for 100 HEP/mL — 75; 0 positive reaction
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 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 (Biological)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- Inmunotek S.L.
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity for 100 HEP/mL |
75; 0 | — |
| PRIMARY Sensitivity for 50 HEP/mL |
74; 0 | — |
| PRIMARY Sensitivity for 25 HEP/mL |
63; 0 | — |
| PRIMARY Sensitivity for 10 HEP/mL |
58; 0 | — |
| PRIMARY Specificity for 100 HEP/mL |
0; 126 | — |
| PRIMARY Specificity for 50 HEP/mL |
0; 126 | — |
| PRIMARY Specificity for 25 HEP/mL |
12; 126 | — |
| PRIMARY Specificity for 10 HEP/mL |
16; 126 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT02527187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.