E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allergy to Artermisia vulgaris |
Alergia a Artemisia vulgaris |
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E.1.1.1 | Medical condition in easily understood language |
Allergy to Artemisia pollen |
Alergia al polen de Artemisia |
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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 | 14.1 |
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 primary objective is to assess the concentration of Artemisia vulgaris allergen extract that elictis a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution. |
El objetivo principal consiste en evaluar la concentración de extracto alergénico de Artemisia vulgaris que provoca una pápula de un tamaño equivalente a la producida por una solución de diclorhidrato de histamina a 10 mg/ml. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to perform the in vitro characterization of the internal reference preparation from subjects' serum, to determine their in vitro biological potency and to guarantee the cosistency of the biological potency of the product batch by batch |
El objetivo secundario es realizar la caracterización in vitro de dicho PRI a partir del análisis de sueros de los sujetos, para determinar su potencia biológica in vitro y poder garantizar la consistencia de la potencia biológica del producto lote a lote |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Positive clinical history of inhalatory allergy to Artemisia vulgaris with (rhinitis and/or rhinoconjunctivitis and / or asthma) -Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable) - Subject can be male or female of any race and ethinic group - Age ? 18 years and ? 60 years at the study inclusion day - A positive prick test with a standardized commercially Artemisia vulgaris allergen extract (Wheal medium diameter ? 3mm or wheal area ? 7 mm2). The skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study - A positive test for specific IgE to Artemisia vulgaris (CAP-RAST major or equal to 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study. - Allergy symptoms during the Artemisia vulgaris pollen season. |
- Historia clínica positiva de alergia inhalatoria (rinitis y/o rinoconjuntivitis y/o asma) frente a Artemisia vulgaris . - El sujeto (y/o su representante legal, si procede) ha otorgado su consentimiento informado por escrito, y lo ha firmado y fechado debidamente. - Sujetos de ambos sexos, de cualquier raza y grupo étnico. - Edad ? 18 años y ? 60 años en el día de la inclusión en el ensayo. - Un prick test positivo (diámetro medio de la pápula ? 3mm o área de la pápula ? 7 mm2) con un extracto alergénico estandarizado comercial de Artemisia vulgaris. Los resultados de la prueba prick-test serán válidos si se realizaron en el año previo a la inclusión del sujeto en el ensayo. - Una prueba positiva de IgE específica de Artemisia vulgaris (CAP-RAST ? 2). Los resultados de la prueba de IgE serán válidos si se realizaron en el año previo a la inclusión del sujeto en el ensayo. - Síntomas alérgicos durante la estación polínica de Artemisia vulgaris. |
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E.4 | Principal exclusion criteria |
-Immunotherapy in the past 5 years with an allergen extract Artemisia vulgaris or other allergen extract that may interfere with the allergene to be tested (for example: Helianthus annuus (sunflower) elatior Ambrosia eiator (ambrosia) or peach. -Use of drugs that may interfere before and after with the skin reactions (for example: antihistamines). See appendix 1 of the protocol. -Treatment with any of the following medications: oral tricyclic or tetracyclic antidepressants, beta-blockers, corticosteroids (major 10 mg/daily of prednisone or equivalent). - Women who are pregnant or breastfeeding period and women with positive pregnancy test at Visit 2, before skin prick test -Dermographism affecting the skin area at the test site at either study visit. -Atopic dermatitis affecting the skin area at the test site at either study visit. -Urticaria affecting the skin area at the test site at either study visit. -Diseases of the immune system relevant clinically, both autoimmune and immunodeficiencies -Serious diseases not controlled that may increase the risk for the safety of the subjects involved in this study, including, but not limited to the following: heart failure, uncontrolled or severe respiratory diseases, endocrine diseases, clinically relevant kidney or liver diseases or hematological diseases. -Participation in any other clinical trial within 30 days (or 5 times the biological half-life of the research of the study product, whichever is longer) prior to the inclusion of the subject in this clinical trial. -Patients with diseases or conditions that limit the use of adrenaline (heart disease, severe hypertension, ..) -Severe psychiatric, psychological or neurological disorders -Abuse of alcohol, drugs or medicines in the previous year. -Subjects who have received anti-IgE (Omalizumab) |
-Inmunoterapia en los últimos 5 años con un extracto alergénico de Artemisia vulgaris u otros extractos alergénicos que puedan interferir con el alérgeno a testar por presentar un alto grado de reactividad cruzada (por ejemplo: Helianthus annuus (girasol), Ambrosia eliator (ambrosía) o melocotón. -Uso de fármacos que puedan interferir con la respuesta cutánea antes y durante el estudio (por ejemplo: antihistamínicos) dentro de los plazos establecidos en el apéndice 1. -Tratamiento con cualquiera de los siguientes medicamentos: antidepresivos tricíclicos, tetracíclicos o IMAOs, betabloqueantes, uso crónico de corticoides orales, o uso de corticoides vía oral o parenteral en pautas repetidas e intermitentes (> 10 mg/día de prednisona o equivalente). -Mujeres que estén embarazadas o en periodo de lactancia -Dermografismo que afecte a la zona de la piel en la que se realiza la prueba, en cualquiera de las dos visitas del ensayo. -Dermatitis atópica que afecte a la zona de la piel en la que se realiza la prueba, en cualquiera de las dos visitas del ensayo. -Urticaria que afecte a la zona de la piel en la que se realiza la prueba, en cualquiera de las dos visitas del ensayo. -Enfermedades del sistema inmunitario relevantes clínicamente, tanto autoinmunes como inmunodeficiencias. -Enfermedades graves no controladas que puedan aumentar el riesgo para la seguridad de los sujetos que participen en este estudio, incluyendo, pero no limitando, las siguientes: insuficiencia cardiaca, enfermedades respiratorias graves o no controladas, enfermedades endocrinas, enfermedades hepáticas o renales clínicamente relevantes o enfermedades hematológicas. -Participación en cualquier otro ensayo clínico en los 30 días (o 5 veces la semivida biológica del producto en investigación del estudio, lo que sea más largo) previos a la inclusión del sujeto en este ensayo clínico. -Sujetos con enfermedades o trastornos que limiten el uso de adrenalina (enfermedades coronarias, HTA grave, etc). -Trastornos psiquiátricos, psicológicos o neurológicos graves. -Abuso de alcohol, drogas o medicamentos en el año anterior. -Sujetos que hayan recibido tratamiento anti-IgE (Omalizumab). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The wheal size area (mm2) which is produced on the skin after application of Artemisia vulgaris allergen extract at various concentrations, along with the wheal area induced by the positive control and the negative by Skin prick Test technique. |
El área de la pápula (mm2) que se produce en la piel después de la aplicación del extracto Artemisia vulgaris a distintas concentraciones, junto con el área de las pápulas inducidas por el control positivo y el negativo, mediante la técnica del Skin Prick-Test. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary endpoint will be determined after the last patient last visit (end of study) |
La variable principal se determinara tras la UVUP (fin de estudio) |
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E.5.2 | Secondary end point(s) |
The power of the PRI in vitro will determinate througth the implementation of inmunoassays, and shall be expressed in units of biolofical activity: -Specific IgE. -Competitive inhibition of specific IgE. |
La potencia del PRI in vitro se determinará mediante la realización de inmunoensayos, y se expresará en unidades de actividad biológica: -Determinación de IgE específica. -Inhibición competitiva de IgE especifica. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The secondary endpoint will be determined after the last patient last visit (end of study) |
La variable secundaria se determinara tras la UVUP (fin de estudio) |
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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 | Yes |
E.8.1.7.1 | Other trial design description |
Los parametros de control estarán siempre incluidos en cada uno de los sujetos |
Control parametres are all ways included in each of the subjects |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Control positivo, (Diclorhidrato de Histamina) y Control negativo (solución salina) |
(Positive Control) and (Negative Control) |
|
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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
|
LPLV |
UVUP. Última visita del último paciente |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |