E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rinoconjuntivitis alérgica con o sin asma debido a la sensibilidad al polen de gramineas. |
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E.1.1.1 | Medical condition in easily understood language |
Rinoconjuntivitis alérgica con o sin asma debido a la sensibilidad al polen de gramineas. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
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 | 10001728 |
E.1.2 | Term | Allergic rhinoconjunctivitis |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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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 | 10001705 |
E.1.2 | Term | Allergic asthma |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal 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 |
Valorar la tolerabilidad de la fase de incremento de dosis de AVANZ. La frecuencia de pacientes con reacciones sistémicas será el criterio de valoración principal. |
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E.2.2 | Secondary objectives of the trial |
Aumento de la Inmunglobulina G4 y del factor bloqueante de Inmunoglobulina E; reducción de la reactividad cutanea inmediata. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Pacientes de ambos sexos entre 18 y 65 años. 2.Antecedentes clínicos de rinoconjuntivitis inducida por pólen de gramíneas, con o sin asma, al menos desde la estación anterior de polinización de las gramíneas. 3. SPT positiva al extracto del alérgeno de Phleum pratense. 4.Ig4 específica positiva frente a Phleum pratense documentada 5.Ig E positiva frente a los alergenos del Phleum pratense 6. Exploración física sin hallazgos 7. Las mujeres fértiles deberán tener resultado de embarazo negativo y utilizar métodos anticonceptivos 8. Paciente dispuesto a cumplir en el estudio |
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E.4 | Principal exclusion criteria |
1. FVE menor del 70 % del valor previsto en la selección. 2. Asma no controlada o asma severo. 3. Antecedentes de exacerbación grave del asma o visita a urgencias por asma en los 12 meses anteriores. 4. Sintomas o tratamientos para: infección del tracto respiratorio superior, sinusitis aguda, otitis media aguda u otra infección importante. 5. Tratamiento con corticoides parenterales, orales o IgE en los tres meses anteriores o durante el estudio (excepto medicación de rescate). 6. Tratamiento con IECAS, betabloqueantes (incluídos colirios), antidepresivos tricíclicos, IMAO y otros medicamentos que contengan aluminio tomados diariamente. 7. Tratamiento previo con inmunoterapia con alérgenos del polen de gramíneas en los 5 años anteriores. 8. Antecedentes de choque anafíláctico causado por alimentos, veneno de insectos, ejercicio o medicamentos. 9. Antecedentes de agioedema intenso y recurrentel. 10. Cualquier contraindicación indicada en e1 manua1 del investigador 11. Uso de un medicamento experimental en los 30 días previos a la selección 12. Incapacidad para comprender la naturaleza, alcance y posibles consecuencias del estudio 13. Improbabilidad de completar el estudio 14. Ser un investigador, personal del estudio o familiares inmediatos de estos |
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E.5 End points |
E.5.1 | Primary end point(s) |
La frecuencia de pacientes con reacciones sistémicas durante la fase de incremento de dosis de AVANZ. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Cierre de la base de datos |
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E.5.2 | Secondary end point(s) |
Aumento de IgG4 y del factor bloqueante de IgE |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Cierre de la base de datos |
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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 | Yes |
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 | No |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 20 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |