Allergic Reaction Clinical Trial
Official title:
Quercus Ilex and Quercus Robur Allergen Extracts. Determination of the in Vivo Allergenic Potency in Histamine Equivalent Units (HEP).
The objective of this study is to determine the biological activity of Quercus illex and Quercus robur allergen extracts in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | April 30, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: - Subjects must live in a geographical area where allergic problems caused by Quercus ilex and Quercus robur are relevant. - Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to asthma) to Quercus ilex and Quercus robur. - A positive prick-test (mean papule diameter = 3 mm) with an extract of the same allergen and/or presence of specific IgE against that allergen. - The mean papule area obtained with Histamine dichlorhydrate at 10 mg/mL should be = 7 mm2. - Age: Between 18 and 64 years old. - Subjects must be able to give informed consent. Exclusion Criteria: - Subjects should not be excluded in terms of low or high sensitivity to Quercus ilex and Quercus robur. - Subjects outside the age range. - Subjects who have previously received immunotherapy in the last 5 years for the treatment of asthma or rhinoconjunctivitis for the treatment of asthma or allergic rhinoconjunctivitis induced by allergens that may interfere with Quercus ilex and Quercus robur extracts. - Subjects with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in which the suspension of the systemic antihistamine treatment is contraindicated. - Subjects who have previously presented a severe secondary reaction during the performance of diagnostic skin tests by prick test. - Subjects under treatment with ß-blockers. - Subjects clinically unstable (acute asthma, febrile, etc.). - Subjects with active urticaria lesions, severe active dermographism, severe atopic dermatitis, sunburn, eczema, psoriasis lesions in the area where the prick test is performed (risk of false positives). - Subjects with active viral infection by herpes simplex or herpes varicella zoster in the area where the prick test is performed. - Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HTA, cardiopathy, etc.). - States of the subject in which he/she cannot offer cooperation and severe psychiatric disorders. - Pregnant women or women at risk of pregnancy and lactating women. |
Country | Name | City | State |
---|---|---|---|
Spain | Clínica Subiza, centro de asma y alergia | Madrid |
Lead Sponsor | Collaborator |
---|---|
Inmunotek S.L. |
Spain,
Arntzen FC. Progress in common Nordic Guidelines for the Registration of Allergen Preparations. Arb Paul Ehrlich Inst Georg Speyer Haus Ferdinand Blum Inst Frankf A M. 1983;(78):25-8. — View Citation
Larsen JN, Dreborg S. Standardization of Allergen Extracts. Methods Mol Biol. 2019;2020:63-76. doi: 10.1007/978-1-4939-9591-2_5. — View Citation
Sjöholm I. Standardisation of allergens in Europe. Arb Paul Ehrlich Inst Bundesamt Sera Impfstoffe Frankf A M. 1997;(91):107-10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Size of the induced papule on the skin | Size of the induced papule on the skin when applying each of the concentrations of the allergenic extracts and the positive (histamine) and negative controls, using the prick test. | 15 minutes | |
Primary | Adverse reactions | Mild secondary reactions such as pruritus, erythema, local edema, etc. There is a risk, infrequent and exceptional, of systemic reactions, sometimes severe (urticaria, asthma, anaphylactic shock, etc.). | 30 minutes |
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