E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allergy to Chenopodium album |
Alergia frente a Chenopodium album |
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E.1.1.1 | Medical condition in easily understood language |
Allergy to Chenopodium pollen |
Alergia al polen de Chenopodium |
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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 | 15.0 |
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 Chenopodium album 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 Chenopodium album que provoca una pápula de un tamaño equivalente a la producida por una solución de diclorhidrato 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 > and =18 years and < and =60 years at the study inclusion day. -Positive skin prick test with a standardized commercially available preparation of chenopodium album allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm or an area at least 7 mm2. 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 chenopodium album (CAP-RAST major or equal to 2). IgE results are valid if performed within oneyear prior to the inclusion of the subject in the study. -Allergic symptoms during the pollen season of Chenopodium album. -Medical history positive allergy inhalation (rhinitis and /or rhinoconjunctivitis and/or asthma) from Chenopodium album. |
-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 mayor o igual a 18 años y menor o igual a 60 años en el día de la inclusión en el ensayo. -Un prick test positivo ( diámetro medio de la pápula mayor ó igual a 3mm ó área de la pápula mayor o igual a 7 mm2) con un extracto alergénico estandarizado comercial de Chenopodium album. 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 Chenopodium album(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 Chenopodium album -Historia clínica positiva de alergia inhalatoria ( rinitis y/o rinoconjuntivitis y/o asma ) frente a Chenopodium album. |
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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. -Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1 of the protocol -Treatment with any of the following medications: tricyclic or tetracyclic o IMAOs antidepressants,b-blockers or chronic use of corticosteroids or oral or use of corticoids both via oral or parenteral, in repeated patterns and intermittent (> 10 mg/día de prednisone or equivalent). -Women who are pregnant or period of breastfeeding and women with a pregnancy test positive during the visit 2, prior to the 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. |
-Inmunoterapia en los últimos 5 años con preparaciones alergénicas conocidas que puedan interferir con el alérgeno a testar -Uso de fármacos que puedan interferir con la respuesta cutánea (por ejemplo: antihistamínicos) dentro de los plazos establecidos en el apéndice 1 del protocolo. -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 y mujeres con una prueba de embarazo positivo en la visita 2, antes de la realización del prick test. -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. -Pacientes con enfermedades o trastornos que limiten el uso de adrenalina (enfermedades coronarias, HTA grave, ..) -Trastornos psiquiátricos, psicológicos o neurológicos graves -Abuso de alcohol, drogas o medicamentos en el año anterior. |
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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 |
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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 parámetros de control estarán siempre incluidos en cada uno de los sujetos |
Control parameters are always 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 fenolada glic |
Positive control, negative control |
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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
|
The end of the trial is the last visit of the last subject undergoing the trial |
El final del ensayo es la 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 |