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   44363   clinical trials with a EudraCT protocol, of which   7387   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:2007-000402-67
    Sponsor's Protocol Code Number:MT-03
    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:2007-04-17
    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 number2007-000402-67
    A.3Full title of the trial
    Estudio multicéntrico, randomizado, doble ciego-placebo en Fase I para evaluar la seguridad en niños del liofilizado oral ALK de ácaros
    A.4.1Sponsor's protocol code numberMT-03
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorALK-Abelló 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameLiofilizado oral ALK de ácaros
    D.3.2Product code ALK HDM tablet
    D.3.4Pharmaceutical form Oral lyophilisate
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboOral lyophilisate
    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
    Asma alérgica leve a moderada, mediada por IgE, (con o sin rinoconjuntivitis) a los ácaros del polvo doméstico
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Identificar el rango de dosificación del liofilizado oral ALK de ácaros que muestre un perfil de seguridad que permita una toma diaria (administrada por el propio paciente) a niños de edades comprendidas entre 5-14 años que presenten asma alérgica (con y sin rinitis) ocasionada por acaros del polvo doméstico.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Niños/as de edades 5-14 años
    -Consentimiento informado por escrito previo a la entrada en el ensayo del (de los) padre(s)/tutor y del sujeto cuando éste tenga 12 años o más.
    -Historia clínica de asma leve a moderada inducida por ácaros del polvo doméstico (con o sin presencia simultánea de rinitis) de al menos un año previo a la entrada del ensayo.
    -Necesidad previa de medicación apropiada (según las normas de GINA 2002) para controlar los síntomas del asma.
    -Pruebas cutáneas (SPT) positivas (diámetro de pápula mayor o igual a 3 mm) a Dermatophagoides pteronyssinus o D. farinae (10 HEP).
    -IgE específica a D. pteronyssinus o D. farinae positiva (Clase IgE mayor o igual a 2)
    E.4Principal exclusion criteria
    - VEMS o PEF menor al 70% del valor teórico.
    - Variabilidad del VEMS o PEF myor del 30%
    - Historia clínica de asma y/o rinitis alérgica perenne ocasionada por un alergeno al que el sujeto está habitualmente expuesto y sensibilizado (exceptuando los ácaros del polvo doméstico)
    - En el momento de la randomización, presencia de síntomas de, o tratamiento, para infección respiratoria de vías altas, sinusitis aguda, otitis media aguda u otros procesos infecciosos importantes (la otitis media serosa no es un criterio de exclusión).
    -Alergia alimentaria con síndrome de alergia oral.
    -Historia clínica de sinusitis crónica.
    -Examen físico con hallazgos de relevancia clínica.
    -Dermatitis atópica grave.
    -Inmunoterapia con extractos alergénicos de ácaros del polvo doméstico en los últimos 10 años.
    -Tratamiento previo o concomitante de inmunoterapia con cualquier otro alergeno en los últimos 3 meses.
    -Uso de algún medicamento experimental en los ultimos 30 días o 5 vidas medias, lo que fuese mas largo, previos a la selección.
    -Conocimiento o sospecha de las siguientes enfermedades subyacentes:
    Fibrosis quistica, cancer, dibetes insulino/dependiente, malabsorción o desnutrición, insuficiencia renal o hepática, infección crónica o cualquier evidencia de enfermedad que puedan interferir con el desarrollo del protocolo o dificultar la interpretación de los resultados del protocolo o poner en peligro la seguridad del sujeto (por ejemplo enfermedad cardiovascular clinicamente significativa, enfermedad inmunopatologica grave, inmunodeficiencia adquirida o no, enfermedad hepática, neurológica, psiquiatrica, endocrina o cualquier otra enfermedad sistemica grave.
    -Tratamiento inmunosupresor (excepto corticosteroides para síntomas de alergia)
    -Prueba de embarazo positiva (en mujeres fertiles)
    -Ser familiar cercano del investigador o del personal involucrado en el ensayo
    -Uso de cualquiera de los sigueintes medicamentos antes de la visita de selección:
    Corticosteroides parenterales de accion corta 30 días antes
    Corticosteroides parenterales de acción prolongada (intra-articular o intramuscular) 90 días antes
    Corticosteroides orales 60 días antes
    Antihistamina oral 3 días antes
    Anticuerpos anti-IgE 90 días antes
    Inhibidores de la MAO 21 días antes
    Antidepresivos triciclicos con efecto antihistaminico 14 días antes
    Medicación antipsicótica con efecto antihistaminico 14 días antes
    Pizotifeno 7 días antes
    -Historia de angioedema clínicamente relevante o de shock anafiláctico.
    -Condición mental que impida al padre/tutor entender la naturaleza, ámbito y posibles consecuencias del ensayo y/o evidencia de actitud poco colaboradora.
    - Dificultades para completar el ensayo por cualquier razon posible mudanza o periodos prolongados de viaje durante el tiempo que dure el ensayo.
    -El sujeto o el(los) padre(s)/tutor poco dispuestos a cumplir con los regímenes establecidos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Acontecimientos adversos
    Valoraciones analíticas de seguridad (Parámetros Hematológicos/Bioquímicos)
    Examen físico
    Signos vitales
    Examen oral
    Espirometría
    PEF (registros diarios)
    Análisis inmunológicos
    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 Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Confirmar seguridad en niños
    E.7.2Therapeutic exploratory (Phase II) No
    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 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.8.3 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 Information not present in EudraCT
    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
    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 months4
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Los sujetos menores de 12 años necesitan el consentimiento informado por escrito de al menos uno de los padres o tutor previo a la entrada en el ensayo . En el caso de tener 12 años o más, también el del paciente.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    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)
    Una vez finalizado el estudio, a cada paciente se le ofrecerá 3 años de tratamiento con SLITone de ácaros. El tratamiento se proporcionará de forma gratuita.
    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 Decision2007-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-04-01
    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-Tue Nov 04 02:40:34 CET 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA