Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-024440-15
    Sponsor's Protocol Code Number:DIA-ALT-0111
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-30
    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 number2010-024440-15
    A.3Full title of the trial
    Multicentre, double-blind, randomized, placebo-controlled, parallel-group, clinical trial to evaluates the clinical efficacy and safety of immunotherapy with purified major allergen Alt a 1 in patients with allergic rhinoconjunctivitis with or without mild to moderate asthma, sensitized the fungus Alternaria alternata
    Ensayo clínico multicéntrico, doble ciego, aleatorizado y controlado con placebo, en grupos paralelos, que evalúa la eficacia clínica y seguridad de la inmunoterapia con el alérgeno mayor purificado Alt a 1, en pacientes con rinoconjuntivitis alérgica con o sin asma leve o moderada, sensibilizados al hongo Alternaria alternata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicentre, double-blind, randomized, placebo-controlled, parallel-group, clinical trial to evaluates the clinical efficacy and safety of immunotherapy with purified major allergen Alt a 1 in patients with allergic rhinoconjunctivitis with or without mild to moderate asthma, sensitized the fungus Alternaria alternata
    Ensayo clínico multicéntrico, doble ciego, aleatorizado y controlado con placebo, en grupos paralelos, que evalúa la eficacia clínica y seguridad de la inmunoterapia con el alérgeno mayor purificado Alt a 1, en pacientes con rinoconjuntivitis alérgica con o sin asma leve o moderada, sensibilizados al hongo Alternaria alternata
    A.4.1Sponsor's protocol code numberDIA-ALT-0111
    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 SponsorDIATER Laboratorio de Diagnostico y Aplicaciones Terapéuticas S.A.
    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 supportDIATER Laboratorio de Diagnostico y Aplicaciones Terapéuticas S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDIATER Laboratorio de Diagnostico y Aplicaciones Terapéuticas S.A.
    B.5.2Functional name of contact pointJulian Campos Fernandez
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Gregorio Peces Barba, 2, Leganés
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28918
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491 496 60 13
    B.5.5Fax number+3491 496 60 12
    B.5.6E-mailj.campos@diater.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 nameAlt a 1
    D.3.2Product code Alt a 1
    D.3.4Pharmaceutical form Powder for 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 INNAlérgeno mayor Alt a 1 del hongo de la especie Alternaria alternata
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number0.4
    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 placeboPowder for suspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Allergic rhinoconjunctivitis with or without associated mild or moderate asthma.
    Rinoconjuntivitis alérgica con o sin asma leve o moderada asociada.
    E.1.1.1Medical condition in easily understood language
    Allergic rhinoconjunctivitis with or without associated mild or moderate asthma.
    Rinoconjuntivitis alérgica con o sin asma leve o moderada asociada.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level HLGT
    E.1.2Classification code 10021505
    E.1.2Term Immunology and allergy investigations
    E.1.2System Organ Class 10022891 - Investigations
    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 efficacy of specific immunotherapy with purified major allergen Alt a 1 of the fungus Alternaria alternata administered subcutaneously
    Evaluar la eficacia de la inmunoterapia específica con el alérgeno mayor purificado Alt a 1 del hongo Alternaria alternata administrada por vía subcutánea
    E.2.2Secondary objectives of the trial
    To evaluate the safety of specific immunotherapy with purified major allergen Alt a 1 of the fungus Alternaria alternata administered subcutaneously
    Evaluar la seguridad de la inmunoterapia específica con el alérgeno mayor purificado Alt a 1 del hongo Alternaria alternata administrada por vía subcutánea.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes con edades comprendidas entre los 12 y 55 años.
    2. Paciente que haya otorgado su consentimiento informado para participar en el estudio así como los tutores o representantes legales, si es menor de edad.
    3. Demostración de sensibilidad a la fuente alergénica:
    -Presencia de IgE específica a Alt a 1 0.7 KU/L (CAP) y
    -Pruebas cutáneas alérgeno-específicas positivas (Alternaria alternata y a Alt a 1), al menos con una pápula de 3 mm con respecto al control negativo.
    4. Demostración clínica de patología concordante con cuadros de rinitis o rinoconjuntivitis con o sin asma leve o moderada asociada.
    5. Paciente capaz de cumplir con el tratamiento y de completar una tarjeta diario del paciente durante el desarrollo del estudio, para la autoevaluación de la puntuación de síntomas y registro de medicación sintomática.
    6. Las mujeres en edad fértil deben presentar una prueba de embarazo en orina con resultado negativo en los 7 días previos a la inclusión en el ensayo.
    Además, las mujeres en edad fértil, deben comprometerse a utilizar un método anticonceptivo adecuado durante el estudio si son sexualmente activas.
    7. Pacientes que responda a los criterios anteriores y que considere el investigador que se ha mantenido estable en un periodo de 6 meses previos a la entrada en el estudio.
    1. Pacientes con edades comprendidas entre los 12 y 55 años.
    2. Paciente que haya otorgado su consentimiento informado para participar en el estudio así como los tutores o representantes legales, si es menor de edad.
    3. Demostración de sensibilidad a la fuente alergénica:
    -Presencia de IgE específica a Alt a 1 0.7 KU/L (CAP) y
    -Pruebas cutáneas alérgeno-específicas positivas (Alternaria alternata y a Alt a 1), al menos con una pápula de 3 mm con respecto al control negativo.
    4. Demostración clínica de patología concordante con cuadros de rinitis o rinoconjuntivitis con o sin asma leve o moderada asociada.
    5. Paciente capaz de cumplir con el tratamiento y de completar una tarjeta diario del paciente durante el desarrollo del estudio, para la autoevaluación de la puntuación de síntomas y registro de medicación sintomática.
    6. Las mujeres en edad fértil deben presentar una prueba de embarazo en orina con resultado negativo en los 7 días previos a la inclusión en el ensayo.
    Además, las mujeres en edad fértil, deben comprometerse a utilizar un método anticonceptivo adecuado durante el estudio si son sexualmente activas.
    7. Pacientes que responda a los criterios anteriores y que considere el investigador que se ha mantenido estable en un periodo de 6 meses previos a la entrada en el estudio.
    E.4Principal exclusion criteria
    1. Coexisting autoimmune diseases
    2. In polysensitized that are relevant allergen and uncontrolled.
    3. Having received immunotherapy with Alternaria in the 3 years prior to the commencement of the trial.
    4. Patients with severe asthma.
    5. Malignancies.
    6. Cardiovascular disorders, which may be aggravated by the use of adrenaline.
    7. Active tuberculosis.
    8. Patients treated with beta blockers.
    9. Impossibility of proper enforcement of immunotherapy program.
    10. Pregnant or nursing mothers or women of childbearing age who do not commit to use adequate contraception if sexually active and have not proven to have been surgically sterilized or who have some form of inability to play.
    11. Simultaneous participation in other clinical trials.
    1. Enfermedades inmunológicas coexistentes
    2. En polisensibilizados que lo sean a alérgenos relevantes y no controlados.
    3. Que hayan recibido inmunoterapia a Alternaria en los 3 años previos al comienzo del ensayo.
    4. Pacientes con asma grave.
    5. Enfermedades malignas.
    6. Trastornos cardiovasculares, que puedan ser agravados por el uso de adrenalina.
    7. Tuberculosis activa.
    8. Pacientes en tratamiento con betabloqueantes.
    9. Imposibilidad de adecuado cumplimiento del programa de inmunoterapia.
    10. Mujeres embarazadas o en periodos de lactancia o mujeres en edad fértil que no se comprometan a utilizar métodos anticonceptivos adecuados si son sexualmente activas y no hayan demostrado haber sido esterilizadas quirúrgicamente o que presenten alguna otra forma de incapacidad para la reproducción.
    11. Participación simultánea en otros ensayos clínicos.
    E.5 End points
    E.5.1Primary end point(s)
    A combined index of frequency, severity of symptoms and symptomatic medication use
    Un indice combinado de frecuencia, severidad de síntomas y consumo de medicación sintomática
    E.5.1.1Timepoint(s) of evaluation of this end point
    throughout all the study
    A lo largo de todo el estudio
    E.5.2Secondary end point(s)
    -Frequency and severity of symptoms as a whole or separately.
    -Consumption of symptomatic medication.
    -Assessment of clinical and immunological markers (inflammatory biomarkers: Ee Ig, IgG Ge, IGI G4e)
    -Safety Assessment.
    -Quality of Life Questionnaire rhinitis (15 items).
    -Frecuencia y severidad de sintomas en su conjunto o por separado.
    -Consumo de medicación sintomática.
    -Valoración de marcadores clínicos e inmunológicos (Biomarcadores Inflamatorios: Ig Ee, IgG Ge, IgI G4e)
    -Valoración de la seguridad.
    -Cuestionario de calidad de vida de rinitis (15 items).
    E.5.2.1Timepoint(s) of evaluation of this end point
    throughout all the study
    A lo largo de todo el 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 Yes
    E.6.4Safety Yes
    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) Yes
    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 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 trial3
    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 concerned15
    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
    The end of the trial is the last visit of the last subject undergoing the trial
    El final del estudio es la última visita del último paciente que participe en el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 132
    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: 132
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 132
    F.1.3Elderly (>=65 years) No
    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 state153
    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)
    The treatment or care after the subject has ended the particiation is the expected normal treatment of that condition.
    Tras la finalización del estudio el paciente continuará con los cuidados y tratamientos habituaes de la enfermedad.
    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 Decision2011-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed Apr 24 01:01:25 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA