E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Tratamiento de la rinitis y conjuntivitis inducida por polen de gramíneas en pacientes adultos con síntomas clínicamente relevantes y diagnosticados mediante prueba cutánea de prick positiva y/o test de IgE específica a polen de gramíneas. Treatment of grass pollen induced rhinitis and conjunctivitis in adult patients with clinically relevant symptoms and diagnosed with a positive Skin-prick test and/or specific IgE test to grass pollen. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001726 |
E.1.2 | Term | Allergic rhinitis due to pollen |
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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 |
Determinar los marcadores biológicos relacionados con la tolerancia y la respuesta clínica al tratamiento con GRAZAX®. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Consentimiento Informado por escrito antes de entrar en el estudio. 2.Varón o mujer entre 18 y 65 años de edad. 3.Historia clínica de alergia (rinoconjuntivitis y/o asma) por sensibilización a polen de gramíneas de al menos 1 año de evolución. 4.IgE sérica positiva a polen de gramíneas (CAP clase 2 o superior o equivalente) documentada en los 5 años previos. 5.Prueba cutánea positiva a Phleum pratense mediante (SPT) con un diámetro de pápula ≥ 3 mm. 6.Prueba de embarazo negativa en mujeres potencialmente fértiles. 7.Deseo de cumplir con el presente protocolo |
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E.4 | Principal exclusion criteria |
1.Inmunoterapia previa con polen de gramíneas. 2.Historia clínica de asma y/o rinitis alérgica perenne. 3.Pacientes con contraindicaciones para tratamiento con inmunoterapia de acuerdo a lo establecido por el subcomité de IT de EAACI o la ficha técnica de GRAZAX®. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Determinar los marcadores biológicos que pueden estar relacionados con la tolerancia y repuesta clínica al tratamiento con GRAZAX®. Se realizarán las siguientes determinaciones, series completas de inmunoglobulinas específicas, citoquinas, diagnóstico molecular, análisis poblacional y repuesta linfoproliferativa a los alergenos.Se relacionará con los resultados del tratamiento de GRAZAX® durante 3 años, en cuanto a tolerancia y beneficio clínico. La tolerancia será evaluada, teniendo en cuenta los efectos adversos y el beneficio clínico se basará en una evaluación subjetiva global de los síntomas de rinoconjuntivitis |
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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 | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Mecanismos moleculares y celulares durante el tratamiento con GRAZAX. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |