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    Summary
    EudraCT Number:2005-005636-28
    Sponsor's Protocol Code Number:E04/05/PP-M
    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:2006-06-26
    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 number2005-005636-28
    A.3Full title of the trial
    Valoración de la eficacia a corto plazo de un extracto de Dermatophagoides pteronyssinus, valorado en unidades de masa y administrado por vía subcutánea, en el tratamiento del asma alérgico. Estudio randomizado, doble ciego controlado con placebo
    A.4.1Sponsor's protocol code numberE04/05/PP-M
    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 Yes
    D.2.1.1.1Trade name PANGRAMIN PLUS
    D.2.1.1.2Name of the Marketing Authorisation holderALK-ABELLO
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namePangramin PLUS Dermatophagoides pteronyssinus
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameExtractos alergénicos para administración por vía subcutánea
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3mcgDer1,2mcgDer2
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboSolution 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
    Asma alérgico perenne, con/sin síntomas de rinitis o rinoconjuntivitis, por sensibilización a Dermatophagoides pteronyssinus.
    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
    Evaluar la eficacia a corto plazo e un extracto de D. pteronyssinus administrado por vía subcutánea, basando la eficacia en el porcentaje de pacientes en los que es posible mantener el asma controlado sin necesidad de medicación de fondo o con dosis inferiores a las utilizadas antes de iniciar la inmunoterapia.
    E.2.2Secondary objectives of the trial
    •Diferencias entre grupo activo y placebo en la frecuencia de síntomas asmáticos y el uso de la medicación de rescate necesaria para su control

    •Diferencias entre grupo activo y placebo en la frecuencia de síntomas de rinitis y el uso de la medicación de rescate necesaria para su control

    •Diferencias entre grupo activo y placebo en la frecuencia de días libre de síntomas

    •Diferencias entre grupo activo y placebo en la aparición de exacerbaciones asmáticas

    •Diferencias entre grupo activo y placebo en el número de días escolares/laborales perdidos

    •Diferencias entre grupo activo y placebo en la evolución de la sensibilidad cutánea mediante el uso de pruebas cutáneas por prick-test

    •Diferencias entre grupo activo y placebo en la evolución de la IgG4 e IgE específicas a Dermatophagoides pteronyssinus.

    •Tolerancia de la pauta cluster empleada durante la fase de incremento de dosis y dosis de mantenimiento.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    -Pacientes con asma leve/moderado persistente, con/sin rinoconjuntivitis, por sensibilización a Dermatophagoides pteronyssinus.

    -Edad: 14-55 años (varón o mujer)

    -Pruebas cutáneas positivas a Dermatophagoides pteronyssinus (prick-test ALK-ABELLÓ, S.A., 30 HEP/ml, diámetro de la pápula ≥ 3 mm) y/o IgE específica positiva a Dermatophagoides pteronyssinus (CAP Pharmacia ≥ Clase 2)

    -Obtención del consentimiento informado antes de la inclusión del sujeto en el ensayo

    -Prueba de embarazo negativa en mujeres potencialmente fértiles y que se comprometan a adoptar medidas anticonceptivas durante la duración del estudio.
    E.4Principal exclusion criteria
    -Enfermedades inmunopatológicas o inmunodeficiencias severas

    -Sospecha o presencia de cualquiera de las siguientes enfermedades subyacentes:
    Fibrosis quística, cancer, diabetes insulinodependiente, hipoabsorción o desnutrición, insuficiencia renal o hepática, infección crónica, adicción a drogas o alcoholismo.
    Cardiopatía isquémica o angina que requieran medicación diaria

    -Tratamiento con β-bloqueantes, incluso cuando se administran de forma tópica

    -Trastornos psicológicos severos

    -Dermatitis atópica severa

    -FEV1 < 70% del valor teórico tras el adecuado tratamiento farmacológico

    -Asma severo no controlado con medicación

    -Asma leve intermitente controlado exclusivamente con medicación de rescate

    -Historia de hipersensibilidad a los excipientes de la medicación en ensayo o de cualquier otra medicación a utilizar por protocolo

    -Historia de alergia, hipersensibilidad o intolerancia a la medicación en ensayo o de cualquier otra medicación a utilizar por protocolo

    -Imposibilidad de realizar adecuadamente las pruebas diagnósticas o el tratamiento

    -Fumador habitual (10 ó más cigarrillos al día)

    -Sensibilización a otros alérgenos inhalados (perennes o estacionales) con relevancia clínica para l sujeto

    -Tratamiento con inmunoterapia con ácaros en los 5 años anteriores a su inclusión en el estudio

    -Pacientes que necesiten una dosis de corticoides superior a 800 μg de budesonida o equivalente (500 μg de fluticasona o 1000 μg de beclometasona)
    E.5 End points
    E.5.1Primary end point(s)
    Porcentaje de pacientes en los que se controla la enfermedad asmática, una vez estabilizada, sin necesidad de medicación de control o con dosis inferior a la utilizada antes de iniciar el tratamiento con inmunoterapia
    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 Information not present in EudraCT
    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.8.3 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.8.5The 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 Information not present in EudraCT
    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
    El final del ensayo se producirá cuando al sujeto se le administre la cuarta dosis de mantenimiento de inmunoterapia (segunda dosis mensual), tras dos meses en los que se habrá llevado a cabo la reducción de medicación de fondo para el control del asma.
    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 months6
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state90
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 90
    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 Decision2006-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-05-13
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