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    Summary
    EudraCT Number:2014-003204-70
    Sponsor's Protocol Code Number:DOM-STA-2014-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-03-03
    Trial 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 number2014-003204-70
    A.3Full title of the trial
    Pilot study on asthma control in patients with grass- pollen allergic rhinitis treated with 5 grass-pollen sublingual immunotherapy (Staloral®) vs placebo
    Estudio piloto sobre el control del asma en pacientes con rinitis alérgica a polen de gramíneas tratados con inmunoterapia sublingual de 5 gramíneas (Staloral®) vs placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot study on asthma control in patients with grass- pollen allergic rhinitis treated with 5 grass-pollen sublingual immunotherapy (Staloral®) vs placebo
    Estudio piloto sobre el control del asma en pacientes con rinitis alérgica a polen de gramíneas tratados con inmunoterapia sublingual de 5 gramíneas (Staloral®) vs placebo
    A.3.2Name or abbreviated title of the trial where available
    5GRAPS
    5GRAPS
    A.4.1Sponsor's protocol code numberDOM-STA-2014-01
    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 SponsorDr. Javier Domínguez Ortega
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSTALLERGENES IBERICA S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation3D HEALTH RESEARCH SL
    B.5.2Functional name of contact pointCARMEN SANTOS COCA
    B.5.3 Address:
    B.5.3.1Street AddressBALMES 152, 6-1
    B.5.3.2Town/ cityBARCELONA
    B.5.3.3Post code08008
    B.5.3.4CountrySpain
    B.5.6E-mailcsantos@3dhealth.es
    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 Yes
    D.2.1.1.1Trade name Staloral Pollens maintenance 300 IR/ml sublingual solution
    D.2.1.1.2Name of the Marketing Authorisation holderSTALLERGENES S.A., 6 rue Alexis de Tocqueville, 92160 Antony, France
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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.3.4Pharmaceutical form Sublingual spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSublingual spray, solution
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Respiratory Allergy: Asthma and allergic rhinitis due to grass pollen
    Alergia respiratoria: Asma y rinitis alérgicas por polen de gramíneas
    E.1.1.1Medical condition in easily understood language
    Respiratory Allergy
    Alergia respiratoria
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess asthma control by means of the score difference according to the Composite Asthma Severity Index (CASI)10, which measures and assesses in a multidimensional form the nature of the asthma. This difference will be assessed with respect to the baseline value and between the two treatment groups (Staloral® vs placebo), in patients with grass-pollen allergic rhinitis, after two seasons of treatment
    Evaluar la diferencia de puntuación en el índice compuesto de gravedad del asma (Composite Asthma Severity Index (CASI)10 que permite medir y evaluar de una manera multidimensional la naturaleza del asma. Esta diferencia será evaluada con respecto al valor basal al inicio de tratamiento y entre los dos grupos de tratamiento (Staloral® vs placebo), en pacientes con rinitis alérgica a polen de gramíneas, tras dos estaciones de tratamiento.
    E.2.2Secondary objectives of the trial
    Clinical assessment of asthma and rhino-conjunctivitis in the two treatment groups after the first and second seasons of treatment. Assess the percentage of patients who improve in asthma control (those who pass from partially controlled to well controlled or pass from badly controlled to partially controlled) and who, moreover, maintain or improve in the therapeutic stage of asthma treatment (1-6).
    Assessment of quality of life and satisfaction with regard to treatment.
    Evaluate changes in serum markers (baseline and final): IgE and IgG4 against Php p 1, Php p 5, Php p 7 +12 and explore the response to immunotherapy through variation dependent innate immune markers of dendritic cells as Programmed Cell Death Ligand 1 (PD-L1) or Stabilin 1 (STAB1).
    Assess the safety profile of treatment with Staloral®.
    Rating of pollination within the study period and correlation with symptoms and disease control in both groups.
    Valoración clínica del asma y de la rinoconjuntivitis en los dos grupos de tratamiento tras la primera y la segunda estación de tratamiento. Evaluar la proporción de pacientes que mejoran en el control del asma y que además se mantengan o mejoren en el escalón terapéutico de tratamiento de asma (1-6)
    Valoración de la calidad de vida y satisfacción respecto al tratamiento.
    Evaluar cambios en marcadores séricos (basal y final): IgE e IgG4 frente a Php p 1, Php p 5, Php p 7+12 y explorar la respuesta a inmunoterapia a través de variación de marcadores de inmunidad innata dependientes de células dendríticas como el Programed Cell Death Ligand 1 (PD-L1), C1q, Fetuin A o Stabilin 1 (STAB1)
    Evaluar el perfil de seguridad del tratamiento con Staloral®.
    Valoración de la polinización en el periodo del estudio y correlación con los síntomas y el control de la enfermedad en ambos grupos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Patients of both sexes aged at 12 years of age or over.
    ? Patients with rhinitis or allergic rhino-conjunctivitis who, moreover, suffer asthma due to grass?pollen allergy and present clinical manifestations of asthma during grass-pollen pollination periods (May to July).
    ? Patients who have had persistent rhinitis of moderate or severe intensity during the past year, according to the ARIA classification modified by Valero et al.11
    ? Patients with a clinical diagnosis of allergic respiratory disease, asthma and rhinitis or rhino-conjunctivitis, of at least two years evolution.
    ? Patients with persistent, mild or moderate allergic asthma (GEMA 2009 guide), in which an etiological relation is established with allergy to grass-pollen and clinical manifestations of purely seasonal asthma in grass-pollen pollination periods in Madrid (May to July)
    ? Patients with a CASI index of ? 6 points during the last grass-pollen pollination peak (May-June 2015).
    ? Patients with FEV1 ? 60% during the last grass-pollen pollination peak (May-June 2015).
    ? Sensitization to grass-pollens, detected by prick test (wheal greater than 3 mm diameter on average) using standardized extracts. A prick test of no more than one year old will be accepted as valid at the time of study patient inclusion.
    ? Levels of specific IgE antibodies against main grass-pollen allergens (Phl p 1) ? 17.5 U/ml (class 4 RAST). Laboratory tests of no more than one year old will be accepted as valid at the time of study patient inclusion.
    ? Patients eligible for treatment with allergen immunotherapy who have not received such since February 2011.
    ? Patients who agree to participate in a clinical trial of 3 years duration.
    ? Patients must voluntarily accept to take part in the study, while understanding the procedures and risks that may derive from it and sign a written informed consent form.
    ? Patients must be capable of filling out the self-administered patient?s daily record and questionnaires.
    ? Pacientes de ambos sexos de edad igual o superior a 12 años.
    ? Pacientes con rinitis o rinoconjuntivitis alérgica que además tengan asma debido a alergia a polen de gramíneas que presenten manifestaciones clínicas de asma en la época de polinización de las gramíneas (mayo a julio)
    ? Pacientes con rinitis persistente de intensidad moderada o grave durante el último año, según la clasificación ARIA modificada por Valero et al.11
    ? Pacientes con diagnóstico clínico de enfermedad alérgica respiratoria, asma y rinitis o rinoconjuntivitis, de al menos 2 años de evolución.
    ? Pacientes con asma alérgica persistente leve o persistente moderada en (guía GEMA 2009) en los que se establece una relación etiológica con alergia a polen de gramíneas y con manifestaciones clínicas de asma exclusivamente estacionales en la época de polinización de las gramíneas en Madrid (mayo a julio).
    ? Pacientes con un índice CASI ? 6 puntos durante el último pico polínico de gramíneas (mayo-junio de 2015).
    ? Pacientes con un FEV1 ? 60% durante el último pico polínico de gramíneas (mayo-junio de 2015)
    ? Sensibilización a gramíneas, detectada por prick-test (pápula mayor de 3 mm de diámetro medio) utilizando extractos estandarizados. Se aceptará como válido un prick-test de antigüedad no superior a 1 año de antigüedad en el momento de la inclusión del paciente en el estudio.
    ? Niveles de anticuerpos IgE específicos frente a alérgenos principales de gramíneas (Phl p 1) ? 17,5 U/ml (clase 4 RAST) si los pacientes tienen niveles de anticuerpos IgE específicos frente a alérgenos de olivo (Ole e 1 o extracto completo de olivo) >0,35 and <3,5 U / ml (clase 1-2 RAST). Si los pacientes tienen niveles de anticuerpos IgE específicos frente a los principales alérgenos de olivo (Ole e 1 o extracto completo de olivo) <0,35 U/ml (clase 0 RAST), los pacientes podrán ser incluidos con niveles de anticuerpos IgE específicos frente a principales alérgenos de gramíneas (Phl p 1) ? 3,51 U/ml (clase 3 RAST). Se aceptarán como válidos resultados de laboratorio de antigüedad no superior a 1 año en el momento de la inclusión del paciente en el estudio.
    ? Pacientes elegibles para el tratamiento con inmunoterapia con alérgenos y que no la hayan recibido después de Febrero de 2011.
    ? Pacientes que den su conformidad a participar en un ensayo clínico de 3 años de duración.
    ? Los pacientes deben aceptar voluntariamente participar en el estudio, comprender los procedimientos y riesgos que se derivan del estudio y firmar un formulario de consentimiento informado por escrito.
    ? Los pacientes deben ser capaces de rellenar el diario del paciente y los cuestionarios autoadministrados.
    E.4Principal exclusion criteria
    ? Patients with persistent asthma outside grass-pollen pollination periods.
    ? Patients with intermittent asthma due to another allergen different from grass-pollens while presenting symptoms between the 15th of March and the 15th of August.
    ? Patients with rhinitis and /or rhino-conjunctivitis due to another allergen different from grass-pollens while presenting symptoms between the 15th of March and the 15th of August.
    ? Patients with allergy symptoms of perennial allergens.
    ? Patients who have had asthmatic crises outside the grass-pollen season during the last 3 years (since May 2012)
    ? Patients who smoke or are ex-smokers or do not wish to abstain from smoking during the period that the study lasts (3 years).
    ? Patients with other pulmonary diseases different from asthma.
    ? Patients with FEV1 < 60% at the time of screening.
    ? Patients with severe asthma.
    ? Patients with other nasal diseases different from allergic rhinitis.
    ? Patients with levels of specific IgE antibodies against major allergens of olive (Ole e 1or whole olive extract) of > 3.5 U / ml (class 3 RAST). Laboratory test results of no more than one year old will be accepted (following the same criteria as that for grass-pollens).
    ? Women of a childbearing age who wish to become pregnant during the study period, those who are currently pregnant and/or are breast-feeding, or those who do not wish to use an efficient method of contraception.
    ? Patients who have taken part in another clinical trial during the past month.
    ? Patients taking tricyclic antidepressants, imipramine, central antihypertensives (clonidine or reserpine) or beta-blockers.
    ? Patients who cannot tolerate treatment with Staloral®: hypersensitivity to any of the excipients, serious immune -deficiencies, immune complex diseases, cancer, unstable or badly controlled asthma, autoimmune diseases, diseases that do not tolerate adrenalin usage, serious psychological disorders.
    ? Patients incapable of reading or understanding the quality of life questionnaires used in this study.
    ? Patients who refuse to sign the informed consent form.
    ? Pacientes con asma persistente fuera de la época polínica para el polen de gramíneas.
    ? Pacientes con asma intermitente debido a otro alérgeno distinto del polen de gramíneas si presentan síntomas entre el 15 de marzo y 15 de agosto.
    ? Pacientes con rinitis y/o rinoconjuntivitis debido a otro alérgeno distinto del polen de gramíneas si presentan síntomas entre el 15 de Marzo y el 15 de agosto.
    ? Pacientes con síntomas alérgicos a alérgenos perennes.
    ? Pacientes que hayan tenido crisis de asma fuera de la estación polínica de gramíneas en los 3 últimos años (desde Mayo 2012)
    ? Pacientes fumadores o ex-fumadores o que no quieran abstenerse de fumar durante el tiempo que dura el estudio (3 años).
    ? Pacientes con otras enfermedades pulmonares diferentes al asma.
    ? Pacientes con FEV1 < 60% en el momento del cribado
    ? Pacientes con asma grave.
    ? Pacientes con otras enfermedades nasales diferentes de la rinitis alérgica
    ? Pacientes con niveles de anticuerpos IgE específicos frente a alérgenos principales de olivo (Ole e 1 o extracto completo de olivo) > 3,5 U/ml (clase 3 RAST) Se aceptarán como válidos resultados de laboratorio de antigüedad no superior a 1 año (seguiríamos el mismo criterio que para las gramíneas)
    ? Mujeres físicamente fértiles que tengan previsto quedarse embarazadas durante el transcurso del estudio, estén actualmente embarazadas y/o en periodo de lactancia, o bien que no deseen utilizar un método anticonceptivo eficaz.
    ? Pacientes que hayan participado en otro ensayo clínico durante el último mes.
    ? Pacientes en tratamiento con antidepresivos tricíclicos, imipramina, antihipertensivos centrales (clonidina o reserpina) o betabloqueantes.
    ? Pacientes en los que está contraindicado el tratamiento con Staloral®: hipersensibilidad a alguno de los excipientes, inmunodeficiencias graves, enfermedades por inmunocomplejos, cáncer, asma inestable o mal controlada, enfermedades autoinmunes, enfermedades que contraindiquen el uso de adrenalina, trastornos psicológicos graves.
    ? Pacientes incapaces de leer y/o interpretar los cuestionarios de calidad de vida utilizados en el estudio.
    ? Pacientes que no acepten firmar el consentimiento informado
    E.5 End points
    E.5.1Primary end point(s)
    Composite Asthma Severity Index (CASI)
    Índice compuesto de gravedad del asma: Composite Asthma Severity
    Index (CASI)
    E.5.1.1Timepoint(s) of evaluation of this end point
    AT THE END OF THE STUDY
    A la finalización del estudio.
    E.5.2Secondary end point(s)
    Clinical assessment of asthma.
    Clinical assessment of the rhinoconjunctivitis.
    Evaluate changes in serum markers (baseline and final)
    Evaluate the safety profile of the STALORAL® treatment.
    Pollination in the period of the study and correlation with the symptoms
    and control of the disease in both groups
    Valoración clínica del asma.
    Valoración clínica de la rinoconjuntivitis.
    Evaluar cambios en marcadores séricos (basal y final)
    Evaluar el perfil de seguridad del tratamiento con STALORAL®.
    Polinización en el periodo del estudio y correlación con los síntomas y el
    control de la enfermedad en ambos grupos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    AT THE END OF THE STUDY
    A la finalización 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 No
    E.6.5Efficacy Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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
    LVLS
    Última visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 20
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state74
    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)
    NONE
    NINGUNO
    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 Decision2015-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-15
    P. End of Trial
    P.End of Trial StatusOngoing
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