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    Summary
    EudraCT Number:2018-002225-26
    Sponsor's Protocol Code Number:280789
    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:2019-06-11
    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 number2018-002225-26
    A.3Full title of the trial
    EVALUATION OF THE COFACTORS IN THE MAINTENANCE PHASE REACTIONS AFTER MILK AND EGG ORAL IMMUNOTHERAPY
    EVALUACIÓN DEL PAPEL DE LOS COFACTORES EN LAS REACCIONES DE FASE DE MANTENIMIENTO TRAS LA DESENSIBILIZACIÓN A LECHE Y HUEVO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EVALUATION OF THE COFACTORS IN THE MAINTENANCE PHASE REACTIONS AFTER MILK AND EGG ORAL IMMUNOTHERAPY
    EVALUACIÓN DEL PAPEL DE LOS COFACTORES EN LAS REACCIONES DE FASE DE MANTENIMIENTO TRAS LA DESENSIBILIZACIÓN A LECHE Y HUEVO
    A.4.1Sponsor's protocol code number280789
    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 SponsorHOSPITAL UNIVERSITARIO FUNDACION ALCORCON
    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 supportHOSPITAL UNIVERSITARIO FUNDACION ALCORCON
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPITAL UNIVERSITARIO FUNDACION ALCORCON
    B.5.2Functional name of contact pointHOSPITAL UNIVERSITARIO FUNDACION AL
    B.5.3 Address:
    B.5.3.1Street AddressC/BUDAPEST 1
    B.5.3.2Town/ cityALCORCON
    B.5.3.3Post code28922
    B.5.3.4CountrySpain
    B.5.6E-mailagonzalezm@fhalcorcon.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 Aspirina - Tablet - Acetylsalicylic acid 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBayer SA
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACETYLSALICYLIC ACID
    D.3.9.1CAS number 50-78-2
    D.3.9.2Current sponsor code712884
    D.3.9.3Other descriptive nameenzoic acid, 2-(acetyloxy)-; Salicylic acid acetate; o-Acetoxybenzoic acid; o-Carboxyphenyl acetate; A.S.A.; A.S.A. Empirin; Acenterine; Acesal; Acetal; Aceticyl; Acetilum Acidulatum; Acetisal; Acetol; Acetophen; Acetosal; Acetosalic acid; Acetosalin; Acetylin; Acetylsal; Acetylsalicylic acid; Acidum acetylsalicylicum; Acisal; Acylpyrin; Asagran; Aspro; Asteric; AC 5230; ASA; Benaspir; Bialpirina; Colfarit; Dolean PH 8; Duramax; Ecotrin; Empirin; Endydol; Enterophen; Enterosarein; Enterosarine;
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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) No
    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 placeboConcentrate for oral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Investigate the role of the drug in the possible allergic reactions as a cofactor
    Investigar el papel de los AINEs en las reacciones en fase de mantenimiento (3 años) en pacientes desensibilizados a leche y huevo
    E.1.1.1Medical condition in easily understood language
    Investigate the role of the drug in the possible allergic reactions as a cofactor
    Investigar el papel de los AINEs en las reacciones en fase de mantenimiento (3 años) en pacientes desensibilizados a leche y huevo
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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
    Analyze if the exercise or treatment with NSAIDs increases the risk of reaction in children desensitized to milk and eggs with three or more years in maintenance phase that have not presented reactions after food in the last year.
    Analizar si el ejercicio o el tratamiento con AINES aumenta el riesgo de reacción en niños desensibilizados a leche y huevo con tres o más años en fase de mantenimiento que no hayan presentado reacciones tras el alimento en el último año.
    E.2.2Secondary objectives of the trial
    - Evaluate if there is a relationship between the severity of symptoms at diagnosis or at the beginning of desensitization with non-tolerance of cofactors.
    - Evaluate if there are differences between the IgE specific values ​​and prick test to cow and egg milk proteins, at the beginning of desensitization and at the beginning of the study, between children who tolerate cofactors and those who do not tolerate them.
    - Evaluate the quality of life before and after knowing the tolerance or not to the taking of NSAIDs and the performance of exercise immediately after the ingestion of milk and / or egg
    - Evaluar si existe relación entre la gravedad de los síntomas al diagnóstico o al inicio de la desensibilización con la no tolerancia de los cofactores.
    - Evaluar si existen diferencias entre los valores específicos de prick test e IgE a proteínas de leche de vaca y huevo, al inicio de la desensibilización y al inicio del estudio, entre los niños que toleran los cofactores y los que no los toleran.
    - Evaluar la calidad de vida antes y después de conocer la tolerancia o no a la toma de AINEs y la realización de ejercicio inmediatamente después tras la ingesta de leche y/o huevo.
     
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients seen in our Allergy Unit since 2008 to 2014, that meet all the inclusion criteria:

    • Patients desensitized to milk and / or egg ≥ 12 years, who have 3 years in maintenance phase who have not had reactions in the last year in relation to the food intake (milk or egg) or derivatives; that have been informed and that they sign the corresponding informed consent.
    Se incluirán en el estudio a todo paciente visto en las consultas de Alergología en el período de 2008-2014, que cumplan todos los criterios siguientes:

    •Pacientes desensibilizados a leche y/o huevo ≥ 12 años, que lleven 3 años en fase de mantenimiento que no hayan presentado reacciones en el último año en relación a la toma del alimento al que el paciente esté desensibilizado (leche o huevo) ni derivados; que hayan sido informados tanto los pacientes como los padres o tutores legales de los pacientes y que firmen el consentimiento informado correspondiente.
    E.4Principal exclusion criteria
    • Patients desensitized to milk and / or egg that do not meet the inclusion criteria
    • Patients with a history of severe or moderate uncontrolled asthma
    • Patients who have presented a reaction in relation to the foods or derivatives in the last year
    • Patients who are taking premedication in the maintenance phase
    • Patients diagnosed with hypersensitivity to NSAIDs
    • Patients diagnosed with asthma induced by exercise
    • Pacientes desensibilizados a leche y/o huevo que no cumplen los requisitos previos
    • Pacientes con antecedentes de asma grave o moderada no controlada
    • Pacientes que hayan presentado reacción en relación con la toma de dichos alimentos o derivados en el último año
    • Pacientes que estén tomando premedicación en la fase de mantenimiento
    • Pacientes diagnosticados de hipersensibilidad a AINEs
    • Pacientes diagnosticados de asma inducida por el ejercicio
    E.5 End points
    E.5.1Primary end point(s)
    The tolerance or not to exercise or the taking of NSAIDs after taking the food to which the child is desensitized.
    Las variables principales son la tolerancia o no a la realización de ejercicio o la toma de AINEs tras la toma del alimento al que el niño esta desensibilizado.
    E.5.1.1Timepoint(s) of evaluation of this end point
    In the moment of the drug provocation test
    En el momento de la provocación
    E.5.2Secondary end point(s)
    The secondary variables that will be measured will be the size of the skin test and the values ​​of the specific IgE at the beginning of the desensitization and at the beginning of the study. IgG4 values ​​will also be assessed at the beginning of the study. It will be evaluated if these variables depend on the tolerance or not of the cofactors.
    The impact on the quality of life that gives the tolerance of the cofactors at the beginning, at 3, 6 and 9 months after the provocation will also be valued.
    Las variables secundarias que se medirán serán el tamaño de la prueba cutánea y los valores de la IgE específica al inicio de la desensibilización y al inicio del estudio. También se valorará los valores de IgG4 al inicio del estudio. Se valorará si estas variables dependen de la tolerancia o no de los cofactores.
    Se valorará también el impacto en la calidad de vida que da la tolerancia de los cofactores al inicio, a los 3, 6 y 9 meses tras la provocación.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Skin tests and IgE and IgG4 values ​​will be assessed at the beginning of desensitization and subsequently before the study.
    The impact of quality of life will be assessed before starting the study, at 3, 6 and 9 months.
    Las pruebas cutáneas y los valores de IgE e IgG4 se valorarán al inicio de la desensibilización y posteriormente antes del estudio.
    El impacto de la calidad de vida se valorará antes de iniciar el estudio, a los 3, 6 y 9 meses.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To analyze if the treatment with NSAIDs increases the risk of reaction in children desensitized to milk and egg
    Analizar si el tratamiento con AINES aumenta el riesgo de reacción en niños desensibilizados a leche y huevo
    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 No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 32
    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: 32
    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 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 state32
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 32
    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
    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 Decision2019-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-07
    P. End of Trial
    P.End of Trial StatusOngoing
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