E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allergic rhinoconjunctivitis with/without asthma due to sensitization to Olea europaea (olive) pollen |
Rinoconjuntivitis alérgica con/sin asma por sensibilización a polen de Olea europaea (olivo) |
|
E.1.1.1 | Medical condition in easily understood language |
Allergy to olive pollen |
Alergia a polen de olivo |
|
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 | 14.1 |
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 Olive. |
Valorar la tolerabilidad de la fase de incremento de dosis de AVANZ Olivo |
|
E.2.2 | Secondary objectives of the trial |
Increase in IgG4 and in IgE and reduction in immediate skin reactivity |
Aumento de IgG4 y de IgE y reducción de la reactividad cutánea inmediata |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male and female patients 18-65 years of age.
2. A clinical history of olive pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry.
3. Positive SPT to olive pollen (wheal diameter ? 3 mm).
4. A positive specific IgE against olive pollen (?Class 2; ?0.70 KU/L) documented in the last 5 years |
1. Pacientes de ambos sexos con edades comprendidas entre 18 y 65 años.
2. Antecedentes clínicos de rinoconjuntivitis inducida por el polen de olivo, con o sin asma, al menos un año antes de participar en el ensayo.
3. SPT positivo al extracto del alérgeno de polen de olivo (diámetro de la pápula ? 3 mm).
4. IgE específica positiva frente a polen de olivo (? IgE Clase 2; ?0.70 KU/L) documentada en los últimos 5 años. |
|
E.4 | Principal exclusion criteria |
1. FEV1 < 70% of predicted value at screening after adequate pharmacologic treatment.
2. Uncontrolled or severe asthma.
3. A clinically relevant history of symptomatic perennial allergic rhinitis and/or conjunctivitis caused by an allergen to which the subject is regularly exposed and sensitized.
4. History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
5. At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infection (serous otitis media is not an exclusion criterion).
6. Treatment with parenteral corticosteroids, oral corticosteroids or anti-IgE, angiotensin converting enzyme inhibitors, tricyclic antidepressants, ?-blockers, mono amine oxidase inhibitors and any other drug containing alum taken on a daily basis.
7. Previous treatment by other allergen concomitant IT or immunotherapy with Olea europaea extracts within the previous 5 years
8. History of anaphylactic shock or of severe and recurrent angioedema. |
1. FEV1 <70% del valor teórico en la selección tras un tratamiento farmacológico adecuado.
2. Asma severo o no controlado.
3. Antecedentes de rinitis alérgica perenne sintomática y/o conjuntivitis causada por un alérgeno, al que el paciente está regularmente expuesto o está sensibilizado, excepto polen de olivo.
4. Antecedentes de exacerbación grave de asma o visita a urgencias por asma en los 12 meses anteriores.
5. En la selección, síntomas de, o tratamiento para: infección del tracto respiratorio superior, sinusitis aguda, otitis media aguda u otra infección importante
6. Tratamiento con corticosteroides parenterales, orales, anti-IgE, inhibidores de la enzima convertidora de la angiotensina, antidepresivos tricíclicos, betabloqueantes, inhibidores de la mono amino oxidasa y cualquier otro medicamento que contenga aluminio tomados diariamente o uso de un medicamento en investigación en los 30 días previos a la selección.
7. Tratamiento previo con inmunoterapia concomitante con otros alérgenos o inmunoterapia con extractos de Olea europaea en los 5 años anteriores
8. Antecedentes de shock anafiláctico o de angioedema severo y recurrente. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Frequency of patients with adverse reactions |
Frecuencia de pacientes con reacciones adversas |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After up-dosing phase and one maintenance dose (6 weeks) |
Después de la fase de inicio y una dosis de mantenimiento (6 semanas) |
|
E.5.2 | Secondary end point(s) |
Difference in olive IgE and IgG4 levels from baseline to end of trial. Changes in immediate skin response to olive allergens from baseline to end of trial by parallel line assay |
Diferencia entre valores basales y final de tratamiento en los niveles de IgE e IgG4 específicos de olivo. Cambio en la reactividad cutánea inmediata a olivo desde antes de iniciar el tratamiento hasta el final de tratamiento, medida por ensayo de lineas paralelas |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After up-dosing phase and one maintenance dose (6 weeks) |
Después de la fase de inicio y 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 | 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) | Yes |
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 | No |
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 | 10 |
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
|
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 |