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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005388-30 | EudraCT Number |
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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).
The trial will consist of a single visit, in which the following procedures will be carried out:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extract Q. ilex + extract Q. robur + positive control + negative control | Experimental | There is only one treatment arm. In each subject, one drop of each of the 3 concentrations of each allergenic extract (2 extracts) will be applied in addition to the positive control (histamine 10mg/mL) and the negative control, with prick test. Quercus ilex: 2,500, 500 and 100 μg/mL Quercus robur: 2,500, 500 and 100 μg/mL |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allergenic extract | Other | In each subject a drop of each of the 3 concentrations of both allergenic extracts will be applied in addition to the positive control (histamine) and the negative control. The application will be made in duplicate on the anterior face of the subject's arm. The distance between each application should be approximately 4 cm. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miguel Casanovas, MD | Contact | +34912908942 | mcasanovas@inmunotek.com | |
| Raquel Caballero, BSc | Contact | +34607600638 | rcaballero@inmunotek.com |
| Name | Affiliation | Role |
|---|---|---|
| Javier Subiza, MD | Clinica Subiza, centro de asma y alergia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Subiza, centro de asma y alergia | Recruiting | Madrid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9383897 | Background | Sjoholm I. Standardisation of allergens in Europe. Arb Paul Ehrlich Inst Bundesamt Sera Impfstoffe Frankf A M. 1997;(91):107-10. | |
| 31177492 | Background | Larsen JN, Dreborg S. Standardization of Allergen Extracts. Methods Mol Biol. 2019;2020:63-76. doi: 10.1007/978-1-4939-9591-2_5. |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
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| ID | Term |
|---|---|
| C451253 | grass pollen extract, alum-adsorbed |
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Phase II, open-label, non-randomized trial, with no control group of subjects.
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| 6625583 | Background | 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. No abstract available. |
| D012140 |
| Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |