E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allergy to Quercus ilex and Quercus robur pollen |
Alergia al polen de: Quercus ilex y Quercus robur |
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E.1.1.1 | Medical condition in easily understood language |
Allergy to Quercus ilex and Quercus robur pollen |
Alergia al polen de Quercus ilex y Quercus robur |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036019 |
E.1.2 | Term | Pollen allergy |
E.1.2 | System Organ Class | 100000004870 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective is to evaluate the concentration of allergenic extract of Quercus ilex and Quercus robur that elicits a wheal of a size equivalent to that produced by a solution of histamine dihydrochlorohydrochloride at 10 mg/mL. |
El objetivo principal consiste en evaluar la concentración de extracto alergénico de Quercus ilex y Quercus robur que provoca una pápula de un tamaño equivalente a la producida por una solución de dihidroclorhidrato de histamina a 10 mg/mL. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
* Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to Quercus ilex and Quercus robur. * A positive prick-test (mean diameter of the wheal 3 mm) with an extract of the same allergen and/or presence of specific IgE against that allergen. * The mean area of the wheal obtained with Histamine dichlorohydrate at 10 mg/mL should be 7 mm2. * Age: Between 18 and 64 years old. * Must be able to give informed consent. |
* Historia clínica positiva de alergia inhalatoria (rinitis y/o rinoconjuntivitis y/o asma) frente a Quercus ilex y Quercus robur. * Un prick-test positivo (diámetro medio de la pápula mayor o igual a 3 mm) con un extracto del mismo alérgeno y/o presencia de IgE específica frente a dicho alérgeno. * La media del área de la pápula obtenida con diclorhidrato de Histamina a 10 mg/mL debe ser mayor o igual a 7 mm2. * Edad: Comprendida entre 18 y 64 años. ** Deben ser capaces de otorgar el consentimiento informado. |
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E.4 | Principal exclusion criteria |
* Subjects outside the age range. * Subjects who have previously received immunotherapy in the last 5 years for the treatment of asthma or allergic rhinoconjunctivitis induced by allergens that may interfere with Quercus ilex and Quercus robur allergen extracts. * Subjects with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in which the suspension of 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, hypertension, heart disease, etc.). * Subjects in a state in which they are unable to offer cooperation and severe psychiatric disorders. * Pregnant women or women at risk of pregnancy and lactating women. |
* Sujetos fuera del rango de edad. * Sujetos que hayan recibido previamente inmunoterapia en los últimos 5 años para el tratamiento del asma o de la rinoconjuntivitis alérgicas inducidas por alérgenos que pueda interferir con los extractos de Quercus ilex y Quercus robur. * Sujetos con síntomas importantes de rinoconjuntivitis y/o asma bronquial en los cuales la suspensión del tratamiento antihistamínico por vía sistémica sea contraindicada. * Sujetos que hayan presentado previamente una reacción secundaria grave durante la realización de pruebas cutáneas de diagnóstico mediante prick test. * Sujetos en tratamiento con ß-bloqueantes. * Sujetos inestables de punto de vista clínico (asma agudo, febril, etc.). * Sujetos con lesiones de urticaria activa, dermografismo activo severo, dermatitis atópica severa, quemaduras solares, eczema, lesiones de psoriasis en la zona de realización del prick-test (riesgo de falsos positivos). * Sujetos con infección vírica activa por el herpes simplex, o herpes varicela zoster en la zona de realización del prick-test. * Sujetos que tengan alguna patología en la que esté contraindicada la administración de adrenalina (hipertiroidismo, HTA, cardiopatía, etc.). * Estados del sujeto en que no pueda ofrecer cooperación y trastornos psiquiátricos severos. * Mujeres embarazadas o con riesgo de embarazo y mujeres lactantes. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable consists of the measurement of the skin wheal area induced after the application of each of the 3 concentrations of the allergenic extract, as well as those induced by the positive (histamine) and negative controls, by using prick test. |
La variable de eficacia primaria consiste la medición del área de la pápula inducida en la piel al aplicar cada una de las 3 concentraciones del extracto alergénico, así como los inducidos por los controles positivos (histamina) y negativo, mediante la prueba del prick test. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The size of the wheal shall be measured 30 minutes after application of the allergen extracts. The data shall be collected on the CRF of each subject and recorded in the database. |
El tamaño de la pápula se medirá transcurridos 30 minutos después de la aplicación de los extractos alergénicos. El dato se recogerá el el CRD de cada sujeto y se registrará en la base de datos |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Diclorhidrato de histamina |
Histamine dichlorohydrate |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial will end when the database is locked. |
El ensayo finalizará con el cierre de la base de datos |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |