Immune System Diseases Clinical Trial
— T502Official title:
Extract Allergen From Betula Verrucosa. Test Sensitivity and Specificity of Diagnostic in Prick Test Preparation.
Verified date | May 2022 |
Source | Inmunotek S.L. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 201 |
Est. completion date | November 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Lucus Augusti | Lugo | Galicia |
Lead Sponsor | Collaborator |
---|---|
Inmunotek S.L. |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
1 hour | |
Primary | 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 |
1 hour | |
Primary | 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 |
1 hour | |
Primary | 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 |
1 hour | |
Primary | 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. |
1 hour | |
Primary | 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. |
1 hour | |
Primary | 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. |
1 hour | |
Primary | 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. |
1 hour |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03663933 -
Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation
|
Phase 2 | |
Completed |
NCT03563066 -
Effect of Benralizumab in Atopic Dermatitis
|
Phase 2 | |
Recruiting |
NCT04339777 -
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of Immunity
|
Phase 2 | |
Not yet recruiting |
NCT05969821 -
Clonal Hematopoiesis of Immunological Significance
|
||
Completed |
NCT02916888 -
A Study Comparing the Quality of Life of Patients in the Treatment of Eczema by Pediatric Generalists and Specialists
|
N/A | |
Completed |
NCT01441076 -
Anakinra for Behcet s Disease
|
Phase 1/Phase 2 | |
Completed |
NCT01472263 -
Use of Pentoxifylline in Human T-lymphotropic Virus Type-1 (HTLV-1) Diseases
|
Phase 3 | |
Completed |
NCT03720470 -
Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
|
Phase 3 | |
Suspended |
NCT04642066 -
Cold Water Immersion and Atherosclerosis, Inflammation, Fat Accumulation and Lipid Profile Parameters
|
N/A | |
Completed |
NCT02294552 -
Post-transplantation Cyclophosphamide as GVHD Prophylaxis After HSCT
|
Phase 2 | |
Completed |
NCT01727973 -
Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy
|
Phase 1/Phase 2 | |
Completed |
NCT04103099 -
Impact of HLNatural Immune Supplement on Colds
|
N/A | |
Recruiting |
NCT03344094 -
Mechanism of Action of Ocrelizumab in Multiple Sclerosis
|
N/A | |
Active, not recruiting |
NCT05445284 -
Group Education Trial to Improve Transition for Parents of Adolescents With T1D
|
N/A | |
Recruiting |
NCT06104111 -
Epigenetic Memory of Vitamin D Supplementation
|
Phase 1 | |
Not yet recruiting |
NCT05616117 -
Next-generation Effects of Vitamin D Supplementation in Pregnancy
|
||
Completed |
NCT01490177 -
Single Center Food Allergy Oral Immunotherapy Study
|
Phase 1 | |
Completed |
NCT01510626 -
Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center
|
Phase 1 | |
Completed |
NCT03922087 -
No-worry Baby Project
|
||
Completed |
NCT03688074 -
Study to Evaluate Tezepelumab on Airway Inflammation in Adults With Uncontrolled Asthma (CASCADE)
|
Phase 2 |