E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allergy to Poa pratensis. |
Alergia frente a Poa Pratensis. |
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E.1.1.1 | Medical condition in easily understood language |
Allergy to grass pollen. |
Alergia al polen de una clase de gramínea. |
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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 | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036019 |
E.1.2 | Term | Pollen allergy |
E.1.2 | System Organ Class | 10021428 - Immune system disorders |
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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 Lolium perenne allergen extract that elicits 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 Poa pratensis que provoca una pápula de un tamaño equivalente a la producida por una solución de dihidroclorhidrato de histamina a 10mg/ml. |
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E.2.2 | Secondary objectives of the trial |
In this study there are no secondary objectives. |
No hay objetivos secundarios en este ensayo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-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 ethnic group. -Age > 18 years and < 50 years at the study inclusion day. -Positive skin prick test with a standardized commercially available preparation of Lolium perenne allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. Positive 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 Lolium perenne (CAP-RAST ? 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study. -Allergic symptoms during the pollen season of Lolium perenne. -Mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ? 3 mm. |
-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 50 años en el día de la inclusión en el ensayo. -Un prick test positivo con un extracto alergénico estandarizado comercial de Poa pratensis. El prick test se considerará positivo si el resultado de la prueba cutánea tiene al menos 3 mm de diámetro medio. 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 Poa pratensis (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 Poa pratensis. -La media de los diámetros medios de la pápula obtenida con el dihidroclorhidrato de histamina (10 mg/ml) en el antebrazo 3 mm. |
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E.4 | Principal exclusion criteria |
-Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (e.g., grass group extracts). -Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1 -Treatment with any of the following medications: tricyclic or tetracyclic antidepressants, ?-blockers or corticosteroids (> 10 mg/day of prednisone or equivalent). -Pregnancy. -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. -Participation in another clinical trial within the last month. -Patients with diseases or conditions that limit the use of adrenaline (heart disease, severe hypertension, ..) |
-Inmunoterapia en los últimos 5 años con preparaciones alergénicas conocidas que puedan interferir con el alérgeno a testar (por ejemplo: extractos del grupo de las gramíneas). -Uso de fármacos que puedan interferir con la respuesta cutánea (por ejemplo: antihistamínicos) dentro de los plazos establecidos en el apéndice 1. -Tratamiento con cualquiera de los siguientes medicamentos: antidepresivos tricíclicos o tetracíclicos, betabloqueantes o corticosteroides (> 10 mg/día de prednisona o equivalente). -Embarazo. -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. -Participación en otro ensayo clínico en el mes previo a la inclusión del sujeto en este ensayo clínico. -Pacientes con enfermedades o trastornos que limiten el uso de adrenalina (enfermedades coronarias, HTA grave, ..) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase. |
El área de la pápula(mm2) que se produce en la piel después de la aplicación del extracto. |
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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 determinará tras la UVUP (fin de estudio). |
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E.5.2 | Secondary end point(s) |
No secondary endpoints in this study |
No hay criterios secundarios de valoración en este estudio. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
No aplica. |
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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 paramentros de control estarán incluidos en cada sujeto |
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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: Dihidroclorhidrato de histamina, Control negativo: Solución salina fenolada glicer |
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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
| 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
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Last patient last visit date was considered as the date of completion of clinical trial. |
La fecha de UVUP( última visita del último paciente) se considerará como la fecha de finalización del ensayo clínico. |
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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 |