E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allergic rhinoconjunctivitis induced by Cupressus arizonica pollen. |
Rinoconjuntivitis alérgica inducida por el polen de Cupressus arizonica. |
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E.1.1.1 | Medical condition in easily understood language |
Allergy to Cupressus arizonica. |
Alergia al polen de Ciprés. |
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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 | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039085 |
E.1.2 | Term | Rhinitis allergic |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
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 assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica. |
Evaluar la tolerabilidad de la fase de incremento de dosis de AVANZ® Cupressus arizonica. |
|
E.2.2 | Secondary objectives of the trial |
To assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica based on the incidence of systemic adverse reactions. To evaluate the changes in IgG4 and IgE for Cupressus arizonica. To evaluate the reduction in immediate skin reactivity for Cupressus arizonica. |
Evaluar la tolerabilidad de la fase de incremento de dosis de AVANZ® Cupressus arizonica basándose en la incidencia de reacciones sistémicas. Evaluar los cambios en la IgG4 e IgE frente a Cupressus arizonica. Evaluar la reducción de la reactividad cutánea inmediata frente a Cupressus arizonica. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and female aged 18-65 years. A documented clinically relevant history of Cupressus arizonica pollen induced allergic rhinoconjunctivitis with or without asthma for at least one year prior to trial entry. Positive Skin Prick Test (SPT) response to Cupressus arizonica pollen (wheal diameter ? 3 mm) . Documenting in the last 5 years a positive specific IgE against Cupressus arizonica pollen (? Class 2; ?0.70 KU/L). |
Sujetos de ambos sexos con edades comprendidas entre 18 y 65 años. Antecedentes clínicos de rinoconjuntivitis inducida por el polen de Cupressus arizonica, con o sin asma, desde al menos un año antes de su inclusión en el ensayo. SPT positivo al extracto alergénico de polen de Cupressus arizonica (diámetro de la pápula ? 3 mm) . IgE específica positiva frente a Cupressus arizonica (? IgE Clase 2; ? 0.70 KU/L) documentada en los últimos 5 años. |
|
E.4 | Principal exclusion criteria |
A clinical history of uncontrolled asthma within 3 months prior to screening . Reduced lung function (FEV1 < 70% of predicted value) after adequate pharmacologic treatment. History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months. Previous treatment with immunotherapy with Cupressus arizonica pollen extract within the last 5 years Ongoing treatment with any allergen-specific immunotherapy product. At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant process. A history of anaphylaxis with cardiorespiratory symptoms. A history of recurrent generalised urticaria during the last 2 years. A history of drug-induced facial angioedema or a family history of hereditary angioedema. Any clinically relevant chronic disease A systemic disease affecting the immune system. |
Antecedentes de asma no controlado en los tres meses previos a la inclusión. Función pulmonar reducida (FEV1 < 70% del valor teórico) tras tratamiento farmacológico adecuado. Antecedentes de exacerbación grave de asma o visita a urgencias por asma en los 12 meses anteriores. Inmunoterapia previa en los 5 años anteriores con extractos de polen de Cupressus arizonica Inmunoterapia específica concomitante con otro alérgeno. En la selección, síntomas de, o tratamiento para: infección del tracto respiratorio superior, sinusitis aguda, otitis media aguda u otra infección importante. Antecedentes de shock anafiláctico con síntomas cardiorrespiratorios. Antecedentes de urticaria generalizada recurrente durante los dos últimos años. Antecedentes de angioedema facial inducido por medicamentos o antecedentes familiares de angioedema hereditario. Cualquier patología crónica clínicamente relevante. Afecciones inmunopatológicas sistémicas. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be the frequency of patients with IMP-related AEs. |
El criterio de valoración principal será la frecuencia de sujetos con acontecimientos adversos relacionados con el IMP. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After updosing phase and one maintenance dose (6 weeks) |
Después de la fase de inicio y de una dosis de mantenimiento (6 semanas) |
|
E.5.2 | Secondary end point(s) |
Incidence of systemic adverse reactions (grade I or higher) occurred after AIT, classified according to the EAACI Immunotherapy Task Force. Changes in Cupressus arizonica specific IgG4 and IgE from baseline to end of treatment. Changes in immediate skin response to Cupressus arizonica from baseline to end of treatment as measured by parallel line assay (PLA). |
Incidencia de reacciones sistémicas (grado I o superior) tras inmunoterapia específica (SIT) con AVANZ® Cupressus arizonica de acuerdo a la clasificación de la EAACI. Cambios en la IgG4 e IgE frente a Cupressus arizonica desde el inicio hasta el final del tratamiento. Cambios en la respuesta cutánea inmediata frente a Cupressus arizonica desde el inicio hasta el final del tratamiento, medido mediante un ensayo de líneas paralelas (PLA). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After updosing phase and one maintenance dose (6 weeks) |
Después de la fase de inicio y de una dosis de mantenimiento (6 semanas) |
|
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 | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | 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 | No |
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 | 7 |
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
|
Trial database lock |
Cierre de la base de datos |
|
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 | 6 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |