E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment and diagnosis of allergy to Artemisa vulgaris, Platanus acerifolia and Dermatophagoides farinae. |
Tratamiento y diagnóstico de la alergia a Artemisa vulgaris, Platanus acerifolia y Dermatophagoides farinae. |
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E.1.1.1 | Medical condition in easily understood language |
Treatment and diagnosis of allergy to Artemisa vulgaris, Platanus acerifolia and Dermatophagoides farinae. |
Tratamiento y diagnóstico de la alergia a Artemisa vulgaris, Platanus acerifolia y Dermatophagoides farinae. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
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 | 10021428 - Immune system disorders |
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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 | 10066092 |
E.1.2 | Term | Acaridae allergy |
E.1.2 | System Organ Class | 10021428 - Immune system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10048908 |
E.1.2 | Term | Seasonal 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 |
In-vivo determination of the biological activity of pollen extracts of Artemisa vulgaris, Platanus acerifoia and Dermatophagoides farinae. |
Determinación in vivo de la actividad biológica de los extractos de polen de Artemisa vulgaris, Platanus acerifolia y Dermatophagoides farinae. |
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E.2.2 | Secondary objectives of the trial |
In-vivo determination of the biological activity of pollen extracts of Artemisa vulgaris, Platanus acerifoia and Dermatophagoides farinae. |
Determinación in vivo de la actividad biológica de los extractos de polen de Artemisa vulgaris, Platanus acerifolia y Dermatophagoides farinae. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. History consistent with the allergen to be tested. 2. Subject monosensitized, or clinically relevant sensitization to allergen test only, or primary sensitization (maximum skin reactivity and IgE) to the allergen in question. 3. Wheal diameter to histamine 10 mg / ml ? 3 mm. 4. Age: 18-60 years. 5. Signed written informed consent. 6. Environment correlated with the allergen. 7. Women of childbearing age must submit a urine pregnancy test with negative result at the time of his entering the study Atopic subjects: wheal diameter <3 mm for the pollen of Artemisa vulgaris, Platanus acerifolia and / or Dermatophagoides farinae or other allergens that cross-reactivity with him. Nonatopic subjects: No wheal or papule with a diameter <3 mm for all allergens tested in the baseline visit |
I. Sujetos alérgicos a los extractos alergénicos de polen de Artemisia vulgaris y/o Platanus acerifolia y/o al ácaro de Dermatophagoides farinae,
1. Sujetos con edad entre 18 y 60 años. 2. Los sujetos deben firmar un consentimiento informado. 3. Diámetro de pápula histamina diclorhidrato 10 mg/ml >= 3 mm. 4. Ambiente correlacionado significativamente con el alérgeno. 5. Los pacientes deben haber presentado o presentan en el momento de su inclusión en el estudio sintomatología alérgica debida a su sensibilización al polen de Artemisia vulgaris y/o Platanus acerifolia y/o al ácaro Dermatophagoides farinae 6. Pacientes deben haber obtenido un resultado de prick test >= 3 mm de diámetro para Artemisia vulgaris y/o Platanus acerifolia y/o Dermatophagoides farinae. 7. Paciente que se encuentre en uno de los siguientes grupos: a. Sujeto monosensibilizado a uno de los alérgenos a testar b. Sujeto con sensibilización clínicamente relevante a uno o varios de los alérgenos a testar, c. Sujeto con sensibilización primaria (máxima reactividad cutánea) al polen de Artemisia vulgaris y/o Platanus acerifolia y/o al ácaro de Dermatophagoides farinae 8. Las mujeres en edad fértil deben presentar una prueba de embarazo en orina con resultado negativo en el momento de su incorporación al estudio.
SUJETOS ATÓPICOS: 4. Diámetro de pápula >= 3 mm para: a. Cualquier alérgeno excepto pólenes para el caso de extractos de polen de Artemisia vulgaris y/o Platanus acerifolia b. Cualquier alérgeno excepto ácaros para el caso de Dermatophagoides farinae 5. Para descartar la sensibilización a otros alérgenos, el diámetro de pápula debe ser < 3 mm para: a. Cualquier polen (para el caso de extractos de polen de Artemisia vulgaris y/o Platanus acerifolia) b. Cualquier ácaro (para el caso de Dermatophagoides farinae)
SUJETOS NO ATÓPICOS: No pápula o pápula con un diámetro < 3 mm para todos los alérgenos testados en la visita de basal. |
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E.4 | Principal exclusion criteria |
1. Allergen-specific immunotheraphy in the last 5 years with Artemisa vulgaris and/or Platanus acerifolia and/or Dermatophagoides farinae. 2. Administration of medication that may interfere with the performance or results of testing (prick test). 3. Patients with clinical history of anaphylaxis 4. Patients with chronic urticaria 5. Patients with atopic dermatitis moderate to severe 6. Any medical condition that contraindicates the performance of skin testing by prick test. 7. Pregnant or lactating women. 8. Subjects who participated in another clinical trial 3 months before. |
1. Inmunoterapia específica 5 años antes de su inclusión en el estudio con extracto de polen de Artemisia vulgaris y/o Platanus acerifolia y/o al ácaro de Dermatophagoides farinae 2. Administración de medicación que pueda interferir con la realización o el resultado de la prueba cutánea mediante prick test 3. Pacientes con historia previa de anafilaxias 4. Pacientes con urticaria crónica (dermografismo, ?) 5. Pacientes con dermatitis atópica moderada-severa 6. Cualquier condición clínica que a juicio del investigador contraindique la realización de una prueba cutánea mediante prick test. 7. Mujeres embarazadas o en período de lactancia. 8. Sujetos que hayan participado en otro ensayo clínico 3 meses antes. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Planimetry: The size of the wheal was calculated by planimetry in Bial SA Pharmaceutical Industry and measured in units of mm2. The test is considered positive if the wheal diameter is 3mm, if the diameter is <3 mm the test is considered negative. |
Planimetría: El tamaño de la pápula se calculará mediante planimetría en Bial Industrial Farmacéutica S.A. y se medirá en unidades de mm2. La prueba se considera positiva si el diámetro de la pápula es 3mm; por el contrario, si el diámetro es < 3mm la prueba se considera negativa. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
15 minutes after prick test |
15 minutos tras el prick test |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Standardization of Allergen Extracts of Pollen and acaridae |
Estandarización de extractos alergenicos de polen y ácaros |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Standardization, No first in human and without marketing authorization |
Estandarización. No es una primera administración en humanos y no autorización de comercialización |
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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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Control +: Histamina; Control -:Suero salino |
Control +: Histamina; Control -:Saline |
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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 | 9 |
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 | Information not present in EudraCT |
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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Final review of adverse events of the last subject included in the trialRevisión final de acontecimientos adversos del último sujeto incluido en el trial |
Revisión final de acontecimientos adversos del último sujeto incluido en el ensayo. |
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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 | 3 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |