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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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).

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    Summary
    EudraCT Number:2011-000120-15
    Sponsor's Protocol Code Number:AV-G-02
    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:2011-07-21
    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 number2011-000120-15
    A.3Full title of the trial
    Dosis de mantenimiento de Avanz Phleum pratense
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dosis de mantenimiento de Avanz Phleum pratense
    A.4.1Sponsor's protocol code numberAV-G-02
    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 SponsorALK-Abello A/S
    B.1.3.4CountryDenmark
    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 supportALK-Abello A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationALK-Abello A/S
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street AddressBoege Allé 6-8
    B.5.3.2Town/ cityHorsholm
    B.5.3.3Post code2970
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4545747576
    B.5.5Fax number+4545748697
    B.5.6E-mailMWRDK@alk-abello.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 nameAVANZ Phleum pratense
    D.3.2Product code AVANZ Phleum pratense
    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 INNPhleum pratense extracto de polen
    D.3.9.2Current sponsor code225
    D.3.9.3Other descriptive namePhleum pratense
    D.3.10 Strength
    D.3.10.1Concentration unit SQU Standardised Quality Unit(s) (Deprecated)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number300 to 15000
    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 placeboSuspension 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
    Rinoconjuntivitis alérgica con o sin asma inducida por polen de gramíneas.
    E.1.1.1Medical condition in easily understood language
    Rinoconjuntivitis alérgica con o sin asma inducida por polen de gramíneas.
    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
    Evaluar la eficacia de dos pautas de administración de Avanz Phleum pratense en comparación con placebo en sujetos con rinoconjuntivitis alérgica inducida por polen de gramíneas con o sin asma. La evaluación se basará en la combinación (suma) de la puntuación diaria de medicación de rinoconjuntivitis durante toda la estación polínica de gramíneas.
    E.2.2Secondary objectives of the trial
    Comparar la eficacia entre las dos pautas de administración de Avanz Phleum pratense y placebo respecto a la puntúación diaria de síntomas de rinoconjuntivitis y de la puntuación diaria de medicación de rinoconjuntivitis durante toda la estación polinica de gramíneas.
    Evaluar la seguridad de Avanz Phleum pratense.
    Comparar las dos pautas de administración de Avanz Phleum pratense y placebo en cuanto a parámetros inmunológicos, parámetros farmacoeconómicos, calidad de vida (QOL) y síntomas y medicación de asma en la estación polínica de gramíneas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adultos con antecedentes documentados clínicamente relevantes de rinoconjuntivitis alérgica inducida por polen de gramíneas con o sin asma a pesar de haber recibido tratamiento sintomático durante las estaciones polínicas de gramíneas de 2010 y 2011.
    Historia clínica de rinoconjuntivitis grave que interfiera en las actividades diarias o sueño y que hayan presentado antes de la aleatorización un grado mínimo adecuado de síntomas de rinoconjuntivitis (definido como una puntuación de síntomas diarios de al menos 10 en el peor día de la estación polínica de gramíneas previa.
    SPT positivo a Phleum pratense.
    IgE específica positiva frente a Phleum pratense.
    E.4Principal exclusion criteria
    Antecentes clínicamente relevantes de rinoconjuntivitis alérgica estacional causada por un alérgeno diferente de gramíneas que solape con la estación polínica de gramíneas.
    Asma con una función pulmonar reducida definida como un FEV1 < 70% del valor teorico tras tratamiento farmacológico adecuado.
    Síntomas o tratamiento de una infección de las vías respiratorias superiores, sinusitis aguda, otitis aguda u otro proceso infeccioso relevante en el momento de la aleatorización.
    E.5 End points
    E.5.1Primary end point(s)
    Puntuación diaria combinada (suma) de síntomas y medicación de rinoconjuntivitis promediados durante toda la estacion de polinización.
    La puntuación combinada para cada sujeto se calculará como la suma de las puntuaciones diarias de síntomas y medicación de rinoconjuntivitis durante toda la estación polínica de gramíneas dividida por el número de días con registros en el diario durante toda la estación polínica de gramíneas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cierre de la base de datos.
    E.5.2Secondary end point(s)
    Puntuación diaria de síntomas de rinoconjuntivitis promediada durante toda la estación polínica, calculada para cada sujeto como la suma de la puntuación diaria de síntomas de rinoconjuntivitis durante toda la estación polínica dividida por el número de días con registros en el diario durante toda la estación polínica.
    Puntuación diaria de medicación de rinoconjuntivitis promediada durante toda la estación polínica, calculada para cada sujeto como la suma de la puntuación diaria de medicación de rinoconjuntivitis durante toda la estación polínica dividida por el número de días con registros en el diario durante toda la estación polínica.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cierre de la base de datos.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) 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 No
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Cierre de la base de datos cuando todas las queries se hayan resuelto.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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 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: 450
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 450
    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)
    Al finalizar el ensayo el investigador debe asegurarse de que los pacientes del ensayo tienen acceso a un tratamieno adecuado y disponible para ello. (Sección del protocolo 5.5.8).
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-08
    P. End of Trial
    P.End of Trial StatusCompleted
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