E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of grass pollen induced rhinitis and conjunctivitis in adult patients with clinically relevant symptoms and diagnosed witha positive skin-prick test and / or specific IgE test to grass pollen. |
Tratamiento de la rinitis y de la rinoconjuntivitis 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. |
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E.1.1.1 | Medical condition in easily understood language |
Ocular and nasal symptoms caused by grass allergy in adult patients with relevant symptoms and diagnosed by specific testing. |
Tratamiento de lo síntomas oculares y nasales causados por la alergia al polen de gramíneas en pacientes adultos con síntomas relevantes y diagnosticados mediante pruebas específicas. |
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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 | 15.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001726 |
E.1.2 | Term | Allergic rhinitis due to pollen |
E.1.2 | System Organ Class | 100000004855 |
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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 |
To identify changes in immunological markers measured in grass allergic subjects during treatment with Grazax. |
Identificar cambios en los marcadores inmunológicos medidos en sujetos alérgicos al polen de gramíneas durante el tratamiento con Grazax. |
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E.2.2 | Secondary objectives of the trial |
To identify changes in immunological markers occurring at early time points during immunotherapy treatment. To identify markers which correlate with safety parameters. To identify markers which correlate with perceived efficacy as assessed by a visual analogical scale (VAS). |
Identificar cambios en los marcadores inmunológicos que ocurren durante el inicio del tratamiento con inmunoterapia. Identificar los marcadores que se correlacionan con parámetros de seguridad. Identificar los marcadores que se correlacionan con la eficacia percibida según la evaluación de una escala análogica visual (VAS). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.A history of relevant rhinitis or rhinoconjunctivitis with or without asthma due to grass pollen since at least the pollen season prior to trial entry (GPS 2012). 2.Documented positive specific IgE against Phl p 5 (above or equal to IgE Class 2, above or equal to 0.70 kU/l). 3.Positive Skin Prick Test (SPT) response (wheal diameter above or equal 3 mm) to Phleum pratense (ALK-Abelló). |
1.Historia clínica de alergia (rinoconjuntivitis y / o asma) por sensibilización al polen de gramíneas desde al menos la estación polínica previa (2012). 2.IgE sérica positiva al polen de gramíneas (CAP clase 2 o superior o equivalente). 3.Prueba cutánea positiva a Phleum pratense mediante skin prick test (SPT) con un diámetro de la pápula mayor o igual a 3 mm. |
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E.4 | Principal exclusion criteria |
1.Previous treatment by immunotherapy with grass allergen extracts. 2.Ongoing treatment with any allergen specific immunotherapy product. 3.Previous or ongoing treatment with Omalizumab, mono amine oxidase (MAO) inhibitors or tricyclic antidepressant medication. |
1.Inmunoterapia previa con polen de gramíneas. 2.Estar recibiendo algún tratamiento alérgeno-específico en el momento de la inclusión. 3.Tratamientos previos o en curso con Omazilumab, inhibidores de la enzima mono amino oxidasa (MAO) o antidepresivos tricíclicos. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunological markers: Pre to post treatment change in immunological markers and differences versus placebo. |
Marcadores inmunológicos: Cambio en los marcadores inmunológicos antes y despues del tratamiento y diferencias frente a placebo. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The control time is defined as: Visit 8 (2 years after treatment initiation) |
El momento de evaluación del ensayo se define como: Visita 8 (2 años después del inicio del tratamiento) |
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E.5.2 | Secondary end point(s) |
Pre to 1 month treatment changes in immunological markers. Group comparison in changes in immunological markers in relation to (systemic) adverse reactions and VAS. Safety endpoints: Frequency of: AEs and SAEs. ESIs Vital signs |
Cambio en los marcadores inmunológicos antes y hasta un mes del tratamiento. Comparación en los marcadores inmunológicos en relación a reacciones adversas (sistémicas) y escala visual analógica (EVA) Criterios de valoración de seguridad: Frecuencia de: Efectos adversos y eventos adversos graves. ESIs. Signos vitales |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 4, 9, 12, 21, 24, 25, 28, 33 and 36 months after treatment initiation. |
Después de: 1, 4, 9, 12, 21, 24, 25, 28, 33 y 36 meses del inicio del tratamiento. |
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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 | Yes |
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 |
Inmunological mechanisms of Grazax. |
Mecanismos inmunológicos de 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 | 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) | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 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
|
End of trial is defined as database closure: Approximately 3 months after Last Subject Last Visit. |
El final del ensayo se define como el cierre de la base de datos: aproximadamente 3 meses después de la ultima 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 | 3 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |