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    Summary
    EudraCT Number:2014-001571-31
    Sponsor's Protocol Code Number:6078-PG-PSC-204
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-08-11
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-001571-31
    A.3Full title of the trial
    A randomized (open-label design), parallel group, multicentre study to evaluate the safety and tolerability of two different doses of Depigoid 34% GrassesMix, 33% Olea europaea and 33% Salsola kali a 3000 DPP/ml in subjects with allergic rhinitis or rhinoconjunctivitis, with or without controlled asthma.
    Estudio aleatorizado, abierto, de grupos paralelos, multicéntrico para evaluar la seguridad y tolerabilidad de dos dosis diferentes de Depigoid 34% Mezcla de Gramineas, 33% Olea europaea y 33% Salsola kali a 3000DPP/ml en pacientes con rinitis o rinoconjuntivitis alérgica, con o sin asma controlada.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and tolerability of two different doses of Depigoid , Olea europaea and Salsola kali in subjects with allergic rhinitis or rhinoconjunctivitis, with or without controlled asthma.
    Estudio para evaluar la seguridad y tolerabilidad de dos dosis diferentes de Depigoid Mezcla de Gramineas, Olea europaea y Salsola kali en pacientes con rinitis o rinoconjuntivitis alérgica, con o sin asma controlada.
    A.4.1Sponsor's protocol code number6078-PG-PSC-204
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLaboratorios LETI, S.L. Unipersonal
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLaboratorios LETI S.L.U.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDynamic Science S.L.
    B.5.2Functional name of contact pointLiana de Plasencia Mascuñana
    B.5.3 Address:
    B.5.3.1Street AddressC/ Azcona 31
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28028
    B.5.3.4CountrySpain
    B.5.4Telephone number0034914561105
    B.5.5Fax number0034914561126
    B.5.6E-maill.plasencia@dynasolutions.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDepigoid GrassesMix/Olea europaea/Salsola kali 3000 DPP/ml
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDepigmented modified 34% GrassesMix/33% Olea europaea/33% Salsola kali 3000 DPP/ml
    D.3.9.2Current sponsor codeDP/MG/14-3 GrassesMix/Olea europaea/Salsola kali 3000 DPP/ml
    D.3.9.3Other descriptive namePOLLEN ALLERGEN EXTRACTS
    D.3.9.4EV Substance CodeSUB130721
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with allergic rhinitis or rhinoconjunctivitis, with or without asthma, controlled by triple sensitization to grass pollen, Olea europaea and Salsola kali, susceptible to treatment with immunotherapy.
    Pacientes con rinitis o rinoconjuntivitis alérgica, con o sin asma controlada por triple sensibilización al polen de gramíneas, Olea europaea y Salsola kali, susceptibles de tratamiento con inmunoterapia.
    E.1.1.1Medical condition in easily understood language
    Patients with allergic rhinitis or rhinoconjunctivitis, with or without controlled asthma, to grass pollen, Olea europaea and Salsola kali.
    Pacientes con rinitis o rinoconjuntivitis alérgica, con o sin asma, al polen de gramíneas, Olea europaea y Salsola kali.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10001726
    E.1.2Term Allergic rhinitis due to pollen
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of two different doses of Depigoid 34% GrassesMix, 33% Olea europaea and 33% Salsola kali at 3000 DPP/ml in subjects with allergic rhinitis or rhinoconjunctivitis, with or without controlled asthma.
    Evaluar la seguridad y tolerabilidad de dos dosis diferentes de Depigoid® 34% Mezcla de Gramíneas, 33% Olea europaea y 33% Salsola kali a 3000DPP/ml en pacientes con rinitis o rinoconjuntivitis alérgica, con o sin asma controlada.
    E.2.2Secondary objectives of the trial
    Evaluating the mechanism of action of treatment administered subcutaneously DP/MG/14-13 by measuring immunoserological laboratory parameters: specific IgE and IgG4.
    Evaluar el mecanismo de acción del tratamiento con DP/MG/14-13 administrado por vía subcutánea mediante la medición de los parámetros inmunoserológicos de laboratorio: IgE e IgG4 específicos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who have dated and signed informed consent and are able to comply with study procedures.
    2. Patients aged over 18 years and under 70 years of age at selection visit.
    3. Has an FEV1 or a PEFR value equal or superior to 80% of predicted normal value at selection Visit.
    4. Individuals suffering from allergic rhinitis and/or rhinoconjunctivitis for at least the preceding year, with or without controlled asthma, caused by triple sensitization against Grasses, Olea europaea and Salsola kali.
    - The IgE-mediated sensitization must be verified by the following: Suggestive medical history, and Specific IgE to GrassesMix, Olea europaea and Salsola kali > class II; and positive skin prick test (SPT) to GrassesMix, Olea europaea and
    Salsola kali.
    A SPT will be considered positive when it produces a wheal whose diameter is at least 3 mm.
    - Asthmatic subjects can be included in the trial only if allergic asthma is controlled according to the Global Initiative for Asthma (GINA 2010)
    - Asthmatic subjects must be stable within 3 months prior to Visit 1 and on a stable inhaled steroid dose within 6 weeks prior to Visit 1 and throughout the study.
    5. If a female is of non-childbearing potential, the subject must be postmenopausal for at least 1 year or surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
    6. If a female is of childbearing potential, the subject must be non-lactating and non-pregnant (with a negative pregnancy test result at Visit 1) and must correctly use an effective method of contraception during the study. An effective method of contraception is defined as one that results in a failure rate of less than 1% per year. The following are allowed methods of contraception when used continuously and properly: hormonal contraceptives administered by implant, injection, or orally; complete abstinence; partner?s vasectomy if the female has not more than one partner. Barrier methods (e.g., preservatives) are only considered effective if used together with one of the above.
    1. Sujetos que hayan fechado y firmado el consentimiento informado y con capacidad para cumplir con los procedimientos del estudio.
    2. . Sujetos con edades comprendidas entre 18 y 70 años (ambas inclusive) en la visita de selección o Visita 1 (V1) del estudio.
    3. Presentar un valor de FEV1 superior o igual al 80% del valor normal previsto en la Visita 1.
    4. Sujetos que sufran de rinitis o rinoconjuntivitis alérgica moderada-severa durante al menos el año anterior, con o sin asma controlada, causada por triple sensibilización a polenes de gramíneas, Olea europaea y Salsola kali .
    - Esta sensibilización mediada por IgE debe ser verificada por: Historia clínica sugestiva de sensibilización, e IgE específica ? 0,7 KU/l (clase II) para mezcla de gramíneas, Olea europaea y Salsola kali . Los resultados de IgE son válidos si se realizaron dentro del año previo a la Visita 1, y Prueba positiva de punción cutánea (Skin Prick Test, SPT) para mezcla de gramíneas, Olea europaea y Salsola kali.
    Se considerará positivo un SPT cuando se produzca un habón de diámetro superior los 3 mm.
    - Los sujetos asmáticos pueden ser incluidos en el estudio sólo si el asma está controlado de acuerdo con los criterios de la Global Initiative for Asthma (GINA actualización 2014).
    - Los sujetos asmáticos deben haber permanecido estables durante al menos las 4 semanas previas a la Visita 1 y tratados con una dosis estable de esteroides inhalados durante las 6 semanas previas a la Visita 1, además de a lo largo de todo el estudio.
    5. Si una mujer no tiene capacidad de concebir, este hecho deberá demostrarse en base a una condición postmenopáusica de al menos un año o en base a la existencia de esterilización quirúrgica previa (por ejemplo, ligadura de trompas bilateral, ooforectomía bilateral, o histerectomía).
    6. Si una mujer está en edad fértil, deberá ser no lactante y no estar embarazada (según resultado negativo en la prueba de embarazo realizada en la Visita 1), además de utilizar correctamente un método anticonceptivo eficaz durante el curso del estudio. Los métodos anticonceptivo eficaces se definen como aquellos que resultan en una tasa de fracaso inferior al 1% por año. Los siguientes métodos anticonceptivos están autorizados cuando se utilizan de forma constante y adecuada: anticonceptivos hormonales administrados por implantes, inyecciones o vía oral; abstinencia completa; vasectomía de la pareja si la mujer no tiene más de una pareja. Los métodos de barrera (por ejemplo, preservativos) sólo se considerarán eficaces si se utilizan junto con alguno de los anteriores.
    E.4Principal exclusion criteria
    1. Any contraindication for treatment with allergen immunotherapy.
    2. Subjects with a previous history of anaphylaxis.
    3. Patients with hospital admission due to asthma exacerbations within 1 year prior to V1.
    4. Has uncontrolled allergic asthma, according to Global Initiative for Asthma Guidelines (GINA 2014f).
    5. Acute or chronic infectious conjunctivitis.
    6. Has acute or chronic inflammatory or infectious airways disease.
    7. Has chronic structural diseases of the affected organ (e.g. eye, nose, lung).
    8. History or presence of confirmed or potential diseases of the immune system including autoimmune diseases and immune deficiencies of actual clinical relevance.
    9. Has any disease that prohibits the use of adrenaline (e.g., hyperthyroidism).
    10. Has a severe uncontrolled disease that could increase the risk to the subjects while participating in the study, including but not limited to, the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disorders.
    11. Subjects with chronic urticaria.
    12. Subjects with moderate-severe atopic dermatitis (subjects with a SCORAD value >30 can not participate in the study).
    13. Has had active malignant disease during the previous 5 years.
    14. Has a significant abnormal laboratory parameter or alteration in vital signs that could increase the risk to the study patient.
    15. Has used immunotherapy with allergen extracts from Grasses, Olea europaea or Salsola kali within the last 5 years or is receiving allergen specific immunotherapy with other allergens during the study period.
    16. Has used systemic and/or topical treatment with beta-blocker drugs within 1 week prior to Visit 2 (first IMP administration).
    17. Used psychotropic, tricyclic, tetracyclic and MAOI antidepressants within 1 month prior to Visit 1. It will not be allowed to perform a washout period of psychotropic or antidepressants to enter the study because of the risks of interrupting the treatment.
    18. Used systemic corticosteroids within 3 months prior to Visit 1.
    19. Treatment with substances interfering with the immune system 2 weeks before Visit 2 (first IMP administration).
    20. Immunization with prophylactic (bacterial or viral) vaccines within 7 days prior to Visit 2 (first IMP administration). Prophylactic vaccines are allowed during the administration of IMP period provided they are administered at least one week after immunotherapy and the next immunotherapy dose is administered at least 14 days later.
    21. Exposure to any investigational drug within one month or 6 half lives of the drug (whichever is longer).
    22. Has abused alcohol, drugs or medications within the past year prior to Visit 1.
    23. Lack of cooperation or compliance with study procedures.
    24. Subjects with severe psychiatric, psychological, neurological disorders or mental condition which unable the subject to understand the nature, scope and possible consequences of the study.
    Los sujetos que cumplan uno o más de los siguientes criterios no son elegibles:
    1. Cualquier contraindicación para el tratamiento con inmunoterapia con alérgenos.
    2. Sujetos con historia previa de anafilaxia.
    3. Sujetos con ingreso hospitalario debido a exacerbaciones asmáticas dentro del año anterior a la Visita 1.
    4. Presencia de asma alérgica no controlada, de acuerdo con los criterios de la Global Initiative for Asthma (GINA 2014f)
    5. Diagnóstico de conjuntivitis infecciosa aguda o crónica.
    6. Enfermedades inflamatorias o infecciosas agudas o crónicas en las vías respiratorias.
    7. Enfermedades estructurales crónicas del órgano diana (p.ej. ojos, nariz, pulmón).
    8. Historia previa o presencia de enfermedades confirmadas o potenciales del sistema inmunitario, tanto enfermedades autoinmunes como inmunodeficiencias con relevancia clínica.
    9. Cualquier trastorno que contraindique el empleo de adrenalina (p.ej. el hipertiroidismo).
    10. Enfermedades no controladas graves que impliquen un riesgo incrementado para los sujetos que participen en este estudio, incluyendo las siguientes pero no limitado a: insuficiencia cardiaca, cualquier enfermedad pulmonar grave o inestable, enfermedades endocrinológicas, enfermedades hepáticas, renales, vasculares o hematológicas clínicamente relevantes.
    11. Sujetos con urticaria crónica.
    12. Sujetos con dermatitis atópica moderada o grave (los sujetos con un valor en el índice SCORAD > 30 no pueden participar en el estudio).
    13. Enfermedad maligna con actividad en los últimos 5 años.
    14. Existencia de un parámetro de laboratorio anormal clínicamente relevante o bien alteración de constantes vitales que puedan aumentar el riesgo para el paciente en el estudio.
    15. El uso de inmunoterapia con extractos alergénicos polenes de gramíneas, Olea europea o Salsola kali durante los últimos 5 años o el tratamiento con inmunoterapia específica con otros alérgenos durante el período de estudio.
    16. Tratamiento sistémico o tópico con fármacos betabloqueantes en la semana previa a la visita 2 (correspondiente a la primera administración del PEI).
    17. Uso de antidepresivos psicotrópicos, tricíclicos, tetracíclicos o IMAO dentro del mes previo a la Visita 1. No se permitirá la retirada de antidepresivos o psicotrópicos para participar en el estudio, a causa del riego que supone interrumpir el tratamiento.
    18. Uso de corticosteroides sistémicos en los 3 meses previos a la Visita 1.
    19. Tratamiento con sustancias que interfieren con el sistema inmunitario 2 semanas antes de la Visita 2.
    20. Inmunización con vacunas profilácticas (bacterianas o virales) en los 7 días anteriores a la Visita 1 y en los 7 días anteriores a la Visita 2 (correspondiente a la primera administración de PEI). Las vacunas profilácticas están permitidas durante el período de tratamiento con el PEI siempre que se administren al menos una semana después del PEI, y cuando la siguiente administración del PEI se produzca al menos 14 días después de la vacuna.
    21. Exposición a cualquier fármaco en fase de investigación durante un mes o el equivalente a seis veces la vida media del producto (el período que resulte mayor).
    22. Abuso de alcohol, drogas o fármacos en el año anterior a la Visita 1.
    23. Falta de cooperación o de cumplimiento de los procedimientos del estudio.
    24. Donación de células germinales, sangre, órganos y/o médula ósea durante la duración del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Number of subjects (%) suffering from immediate or delayed systemic ? grade 2 reactions, according to EACCI 2006 classification, along the study.
    Número de sujetos (%) que padecen una reacción sistémica inmediata o tardía de grado 2 o superior, según los criterios de EAACI de 2006.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During study visits.
    Durante las visitas del estudio.
    E.5.2Secondary end point(s)
    Secondary end points:
    - Patients (%) sufering from immediate or delayed local reactions classified by the diameter of induration and dose received
    - Patients (%) suffering from immediate or delayed systemic reactions classified by grade (EACCI classification) and dose received
    - Patients (%) withdrawn from the study due to local reactions classified by dose received
    - Patients (%) withdrawn from the study due to local reactions classified by dose received during the build-up phase
    - Patients (%) withdrawn from the study due to systemic reactions classified by dose received
    - Patients (%) withdrawn from the study due to systemic reactions classified by dose received during the build-up phase
    - Patients (%) with adverse events (AE) classified by dose received
    - Number of immediate or delayed local reactions classified by diameter of induration and dose received
    - Number of immediate or delayed systemic reactions classified by grade (EACCI classification) and dose received
    - Change of lung function parameters before and after each administration of the IMP.
    - Change from baseline to Visit 4 in laboratory parameters

    Exploratory end points:
    - Immunologic response measured by immunology laboratory parameters: specific IgE and IgG4 to the complete allergenic extracts of GrassMix, Olea europaea and Salsola kali.
    Variables secundarias:
    - Número de sujetos (%) que padecen reacciones locales inmediatas o tardías desglosadas por diámetro de induración y dosis recibida.
    - Número de sujetos (%) que padecen reacciones sistémicas inmediatas o tardías, desglosadas por grado (clasificación de EAACI) y dosis recibida.
    - Número de sujetos (%) que abandonaron el estudio debido a reacciones locales desglosadas por la dosis recibida.
    - Número de sujetos (%) que abandonaron el estudio debido a reacciones locales desglosadas por la dosis recibida durante la fase de escalado.
    - Número de sujetos (%) que abandonaron el estudio debido a reacciones sistémicas desglosadas por la dosis recibida.
    - Número de sujetos (%) que abandonaron el estudio debido a reacciones sistémicas desglosadas por la dosis recibida durante la fase de escalado.
    - Número de sujetos (%) con AA desglosados por la dosis recibida.
    - Número de reacciones locales inmediatas o tardías desglosadas por el diámetro de induración y la dosis recibida.
    - Número de reacciones sistémicas inmediatas o tardías desglosadas por grado (clasificación de EAACI) y dosis recibida.
    - Cambio de los parámetros de la función pulmonar antes y después de cada administración del PEI.
    - Cambio en los parámetros de laboratorio desde basal hasta Visita 4.

    Variables exploratorias:
    - Respuesta inmunológica medida mediante parámetros inmunológicos (niveles de IgE e IgG4 específicas) a los extractos alergénicos de Mezcla de Gramíneas, Olea europaea y Salsola kali.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During study visits.
    Durante las visitas del estudio.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Inmunoterapia a 2 dosis distintas: grupo dosis 3.000 DPP vs grupo dosis 2.000 DPP
    Immunotherapy at 2 different doses: 3.000 DPP group vs 2.000 DPP group
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    Last patient last visit.
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 71
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 71
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state71
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the end of the study, patients who completed the clinical trial, will be given the option to benefit from receiving a full course of treatment (3 years) for their allergy for 3 consecutive years with allergenic extracts which are marketed.
    Al final del estudio, a aquellos pacientes que completen el proyecto de investigación, se les ofrecerá la posibilidad de recibir un ciclo completo de tratamiento (3 años) para su alergia con el extracto actualmente comercializado.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-06-22
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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