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    Summary
    EudraCT Number:2016-004363-39
    Sponsor's Protocol Code Number:MT-11
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2017-10-20
    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 number2016-004363-39
    A.3Full title of the trial
    A phase III trial evaluating the efficacy and safety of the house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet in children and adolescents (5-17 years) with HDM allergic asthma
    Ensayo de fase III, para evaluación de la eficacia y la seguridad de unos comprimidos sublinguales de inmunoterapia frente a ácaros del polvo doméstico, en niños y adolescentes (de 5 a 17 años) con asma alérgica inducida por ácaros del polvo doméstico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to check efficacy and safety of house dust mite tablets in children and adolescents with allergic asthma
    Ensayo clinico para comprobar la eficacia y la seguridad de unos comprimidos en niños y adolescentes con asma alérgica inducida por ácaros del polvo doméstico
    A.4.1Sponsor's protocol code numberMT-11
    A.5.4Other Identifiers
    Name:IND NumberNumber:17691
    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-Abelló 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-Abelló A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationALK-Abelló A/S
    B.5.2Functional name of contact pointHead of Clinical Project Management
    B.5.3 Address:
    B.5.3.1Street AddressBØGE ALLÉ 6-8
    B.5.3.2Town/ cityHørsholm
    B.5.3.3Post codeDK-2970
    B.5.3.4CountryDenmark
    B.5.4Telephone number+34917547272
    B.5.6E-mailclinicaltrials@alk.net
    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 ACARIZAX
    D.2.1.1.2Name of the Marketing Authorisation holderALK-Abelló A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameSQ HDM SLIT-tablet
    D.3.4Pharmaceutical form Oral lyophilisate
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDERMATOPHAGOIDES FARINAE EXTRACT
    D.3.9.3Other descriptive nameDERMATOPHAGOIDES FARINAE EXTRACT
    D.3.9.4EV Substance CodeSUB84530
    D.3.10 Strength
    D.3.10.1Concentration unit SQU Standardised Quality Unit(s) (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDERMATOPHAGOIDES PTERONYSSINUS EXTRACT
    D.3.9.3Other descriptive nameDERMATOPHAGOIDES PTERONYSSINUS EXTRACT
    D.3.9.4EV Substance CodeSUB84531
    D.3.10 Strength
    D.3.10.1Concentration unit SQU Standardised Quality Unit(s) (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 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
    House Dust Mite (HDM) Allergic Asthma
    Asma alérgica inducida por ácaros del polvo doméstico
    E.1.1.1Medical condition in easily understood language
    Asthma that is induced by House Dust Mite allergy
    Asma inducida por ácaros del polvo doméstico
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10038738
    E.1.2Term Respiratory, thoracic and mediastinal disorders
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to demonstrate superiority of the HDM SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with HDM allergic asthma based on clinically relevant asthma exacerbations after at least 4 months of treatment.
    El objetivo principal es demostrar la superioridad de los comprimidos de inmunoterapia sublingual (SLIT) frente a placebo como tratamiento complementario en niños y adolescentes (5-17 años) con asma alérgica inducida por ácaros del polvo doméstico, en función de las exacerbaciones clínicamente relevantes del asma tras como mínimo 4 meses de tratamiento.
    E.2.2Secondary objectives of the trial
    The key secondary objectives are to demonstrate superiority of the HDM SLIT-tablet versus placebo after at least 4 months as add-on treatment in children and adolescents with HDM allergic asthma with respect to:
    • Nocturnal awakening due to asthma which require SABA rescue medication
    • Rescue medication use (SABA)
    • Lung function (FEV1)
    Los objetivos secundarios clave son demostrar la superioridad de los comprimidos de SLIT frente a placebo tras como mínimo 4 meses de tratamiento complementario en niños y adolescentes con asma alérgica inducida por ácaros del polvo doméstico en cuanto a:
    - Despertares nocturnos por asma que hayan precisado tratamiento de rescate con agonistas β2 de acción corta
    - Uso de medicación de rescate (agonistas β2 de acción corta)
    - Función pulmonar (FEV1)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I1. Written informed consent obtained from parents/caregivers before any trial related procedures are performed
    I2. Male or female of any race/ethnicity aged ≥4 to ≤17 years on the day informed consent is obtained from the parent/caregiver. The subject must be ≥5 to ≤17 years old at the randomisation visit
    I3. A female subject of childbearing potential must have a negative pregnancy test and be willing to practise appropriate contraceptive methods until the follow-up TC
    I4. A clinical history of HDM allergic asthma of at least 1 year duration diagnosed by a physician
    I5. Use of low daily dose of ICS plus LABA or medium/high daily dose of ICS with or without LABA for the control of asthma symptoms within the past year prior to randomisation. For definition of ICS doses, please see Table 3 and Table 4
    I6. ≥3 clinically relevant asthma exacerbations in the past two years or ≥2 clinically relevant asthma exacerbations in the past year or ≥1 severe asthma exacerbation in the past year prior to randomization while being on asthma controller medication (low dose ICS plus LABA or medium/high dose ICS with or without LABA) . The asthma controller medication at the screening visit must be at a dose equivalent to or below the dose the subject received before the last asthma exacerbation occurred
    I7. One or more of the following within the past 4 weeks prior to randomisation:
    a. Daytime asthma symptoms more than twice/week
    b. Any nocturnal awakening due to asthma which require use of SABA rescue medication
    c. SABA rescue medication needed for treatment of asthma symptoms more than twice/week
    d. Any activity limitation due to asthma
    I8. Lung function measured by FEV1 ≥ 70% of predicted value or according to local requirements while on background treatment following at least a 6-hour washout of SABA at screening and randomisation
    I9. Clinical history of HDM AR within the last year prior to randomisation
    I10. An average TCRS>0 during the baseline period (period 2)
    I11. Positive specific IgE (defined as ≥class 2, ≥0.70 kU/l) against D. pteronyssinus and/or D. farinae at screening
    I12. Positive SPT to D. pteronyssinus and/or D. farinae at screening
    I13. Subject willing and able to comply with trial protocol
    I1. Firma del documento de consentimiento informado por los progenitores/cuidadores antes de la práctica de cualquier procedimiento del ensayo.
    I2. Sujetos de ambos sexos y cualquier raza/grupo étnico de >=4 a <=17 años de edad el día de obtención del consentimiento informado por parte del progenitor/cuidador. En la visita de aleatorización, el sujeto deberá tener >=5 a <=17 años de edad
    I3. Si se trata de una chica potencialmente fertile deberá arrojar un resultado negativo en una prueba de embarazo y estar de acuerdo en practicar métodos anticonceptivos adecuados hasta la llamada telefónica de seguimiento
    I4. Historia clínica de asma alérgica inducida por ácaros del polvo doméstico de como mínimo 1 año de duración, diagnosticada por un médico.
    I5. Uso de dosis diarias bajas de corticosteroides inhalados más agonista beta2 de acción prolongada o de dosis medias/altas de corticosteroides inhalados, con o sin agonista beta2 de acción prolongada, para el control de los síntomas asmáticos en el año anterior a la aleatorización. Para la definición de las dosis de corticosteroides inhalados, véanse la Tabla 3 y la Tabla 4.
    I6. >=3 exacerbaciones asmáticas clínicamente relevantes en los dos años anteriores o >=2 exacerbaciones asmáticas clínicamente relevantes en el año anterior o >=1 exacerbación asmática severa en el año anterior a la aleatorización mientras estaba recibiendo medicación para el control del asma (corticosteroides inhalados a dosis bajas más agonista beta2 de acción prolongada o dosis medias/altas de corticosteroides inhalados, con o sin agonista beta2 de acción prolongada). La medicación para el control del asma en la visita de Selección deberá ser a dosis equivalentes a o menores que la dosis que el sujeto estaba recibiendo antes de que tuviera lugar la última exacerbación asmática
    I7. Uno o más de los siguientes en el plazo de las 4 últimas semanas antes de la aleatorización:
    a. Síntomas asmáticos diurnos más de dos veces a la semana
    b. Cualquier despertar nocturno por asma que haya precisado el uso de medicación de rescate con agonistas beta2 de acción corta
    c. Necesidad de medicación de rescate con agonistas beta2 de acción corta por síntomas asmáticos más de dos veces por semana
    d. Cualquier limitación de la actividad por asma
    I8. Función pulmonar con FEV1 >= 70% del valor predicho o de acuerdo a los requisitos locales mientras estaba recibiendo su tratamiento de base, tras lavado de como mínimo 6 horas de sus agonistas beta2 de acción corta, en la selección y en la aleatorización
    I9. Historia clínica de rinitis alérgica inducida por ácaros del polvo doméstico en el último año antes de la aleatorización11
    I10. Promedio de la puntuación total combinada de rinitis (total combined rhinitis score, TCRS) > 0 durante el periodo basal (período 2)
    I11. Positividad de la inmunoglobulina E (IgE) específica (lo que se define como >= clase 2, >=0,70 kU/l) frente a Dermatophagoides pteronyssinus (D. pteronyssinus) y/o Dermatophagoides farinae (D. farinae) en la selección
    I12. Positividad de la prueba de punción epidérmica (skin prick test, SPT) 12al D. pteronyssinus y/o al D. farinae en la selección
    I13. Sujeto que está dispuesto a y que puede cumplir con el protocolo del ensayo
    E.4Principal exclusion criteria
    E1. Is sensitised and regularly exposed to animal dander, molds, and/or cockroach (e.g., present in the home, job, school, etc.) or other perennial allergen
    E2. Has experienced a life-threatening asthma attack defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia requiring non-invasive ventilator support
    E3. Within the last month before the randomisation visit (visit 3), has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
    E4. Within the last 3 months before the randomisation visit (visit 3) while on high dose ICS treatment, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
    E5. SLIT treatment with D. pteronyssinus or D. farinae for more than 1 month within the last 5 years. In addition, any SLIT treatment with D. pteronyssinus or D. farinae within the previous 12 months
    E6. SCIT treatment with D. pteronyssinus or D. farinae reaching the maintenance dose within the last 5 years. In addition, any SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months
    E7. Ongoing treatment with any allergy immunotherapy product
    E8. Severe chronic oral inflammation
    E9. Any nasal or naso/oropharyngeal condition that could confound the efficacy or safety assessments (e.g., hypertrophy of the pharyngeal/palatine tonsils, clinically relevant nasal polyps, a history of paranasal sinus surgery or surgery of nasal turbinates)
    E10. Any clinically relevant chronic disease incl. malignancy that in the opinion of the investigator would interfere with the trial evaluations or the safety of the subject
    E11. Has a diagnosis of eosinophilic oesophagitis
    E12. A relevant history of systemic allergic reaction e.g. anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial angioedema that in the opinion of the investigator may constitute an increased safety concern
    E13. Active or poorly controlled autoimmune diseases, immune defects, immunodeficiencies, immunosuppression or malignant neoplastic diseases with current disease relevance
    E14. Ongoing treatment with OCS
    E15. Treatment with restricted and prohibited concomitant medication listed in Table 2
    E16. Treatment with an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening
    E17. A history of allergy, hypersensitivity or intolerance to any of the excipients or active substance of the IMP (except D. pteronyssinus and D. farinae) or to any excipient of the rescue medication provided in this trial
    E18. A business or personal relationship with trial staff or sponsor who is directly involved with the conduct of the trial
    E19. A history of alcohol or drug abuse
    E20. Has previously been randomised into this trial, is participating in this trial at another investigational site or is participating or planning to participate in any other clinical trial during the duration of this trial
    E21. Has a history or current evidence of any condition, treatment, laboratory values out of range or other circumstance that in the opinion of the investigator are clinically relevant and might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject’s participation for the full duration of the trial
    E22. Has a condition or treatment that increase the risk of the subject developing severe adverse reactions after adrenaline/epinephrine administration
    E23. Is unable to or will not comply with the use of adrenaline/epinephrine auto-injectors for countries where this is a regulatory requirement
    E1. Sujeto sensibilizado y expuesto regularmente a epitelios de animales, hongos y/o cucarachas (por ejemplo, presentes en el domicilio, trabajo, colegio, etc.) u otros alergenos perennes
    E2. Ha sufrido un ataque asmático de riesgo vital, lo que se define en este protocolo como un episodio asmático que precisó intubación y/o que cursó con hipercapnia que precisó soporte ventilatorio no invasivo
    E3. En el plazo del último mes antes de la visita de aleatorización (visita 3), ha sufrido un deterioro clínico del asma que resultó en tratamiento de urgencia, hospitalización o administración de corticosteroides sistémicos
    E4. En el plazo de los 3 últimos meses antes de la visita de aleatorización (visita 3), mientras estaba en tratamiento con corticosteroides inhalados a dosis altas, ha sufrido un deterioro clínico del asma que resultó en tratamiento de urgencia, hospitalización o administración de corticosteroides sistémicos
    E5. Tratamiento con SLIT con D. pteronyssinus o D. farinae durante más de 1 mes en los últimos 5 años. Además, cualquier tratamiento con SLIT con D. pteronyssinus o D. farinae en los 12 meses previos
    E6. Tratamiento con inmunoterapia subcutánea (subcutaneous immunotherapy, SCIT) con D. pteronyssinus o D. farinae que alcanzó la dosis de mantenimiento en los 5 últimos años. Además, cualquier tratamiento con SCIT con D. pteronyssinus o D. farinae en los 12 meses previos
    E7. Tratamiento actual con cualquier producto de inmunoterapia para la alergia
    E8. Inflamación oral crónica severa
    E9. Cualquier proceso nasal o naso/orofaríngeo que pudiera actuar como factor de confusión en las evaluaciones de la eficacia o la seguridad (por ejemplo, hipertrofia de amígdalas faríngeas/palatinas, pólipos nasales clínicamente importantes, antecedente de cirugía de senos paranasales o de cornetes nasales)
    E10. Toda enfermedad crónica clínicamente relevante, incluidas las malignas, que, en opinión del investigador, pueda interferir con las evaluaciones del ensayo o la seguridad del sujeto
    E11. Diagnóstico de esofagitis eosinofílica
    E12. Historia importante de reacción alérgica sistémica, por ejemplo, anafilaxia con síntomas cardiorrespiratorios, urticaria generalizada o angioedema facial severo, que, en opinión del investigador, pueda aumentar los riesgos en cuanto a la seguridad
    E13. Enfermedades autoinmunitarias activas o mal controladas, defectos inmunitarios, inmunodeficiencias, inmunosupresión o neoplasias malignas actualmente relevantes
    E14. Tratamiento actual con corticosteroides orales
    E15. Tratamiento con cualquiera de los medicamentos concomitantes restringidos o prohibidos que se señalan en la Tabla 2
    E16. Tratamiento con un fármaco en fase de investigación en el plazo de 30 días/5 semividas del fármaco en cuestión (eligiéndose el mayor de estos plazos) antes de la selección
    E17. Antecedentes de alergia, hipersensibilidad o intolerancia a cualquiera de los excipientes o al principio activo del medicamento en investigación (excepto a D. pteronyssinus y D. farinae) o a cualquier excipiente de la medicación de rescate facilitada en este ensayo
    E18. Relación empresarial o personal con el personal del ensayo o del promotor directamente interviniente en el desarrollo del ensayo
    E19. Antecedentes de abuso de alcohol o drogas
    E20. Aleatorización previa en este ensayo, participación actual en este ensayo en otro centro o participación o programación de participación en otro ensayo clínico durante la duración del presente
    E21. Antecedente o evidencia actual de cualquier proceso, tratamiento, valores anormales de laboratorio u otra circunstancia que, en opinión del investigador, sean clínicamente relevantes y puedan poner al sujeto en riesgo por su participación en el ensayo, confundir los resultados del ensayo o interferir con la participación del sujeto en toda la duración del ensayo
    E22. Proceso o tratamiento que aumenta el riesgo de que el sujeto desarrolle reacciones adversas severas tras la administración de adrenalina/epinefrina
    E23. Incapacidad o no deseo de utilizar los autoinyectores de adrenalina/epinefrina en aquellos países en los que lo requieran las autoridades reguladoras
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the trial is the annualised rate of clinically relevant asthma exacerbations calculated as the number per year per subject during the efficacy evaluation period (period 4).
    A clinically relevant asthma exacerbation must be medically confirmed and is defined as asthma worsening leading to at least one of the following criteria:
    • Doubling of ICS dose compared to background treatment
    • Systemic corticosteroids for treatment of asthma symptoms for at least 3 days
    • Emergency room visit due to asthma, requiring systemic corticosteroids
    • Hospitalisation (admission not required) for more than 12 hours due to asthma.
    El criterio principal de valoración del ensayo es la tasa anualizada de exacerbaciones asmáticas clínicamente relevantes, calculada como su número por año y por sujeto, durante el periodo de evaluación de la eficacia (periodo 4).
    Las exacerbaciones asmáticas clínicamente relevantes, que deberán confirmarse médicamente, se definen como un deterioro del asma que resulta en como mínimo uno de los siguientes criterios:
    - Duplicación de la dosis de corticosteroides inhalados en comparación con el tratamiento de base
    - Corticosteroides sistémicos para el tratamiento de síntomas asmáticos durante como mínimo 3 días
    - Visita a Urgencias por asma que haya precisado corticosteroides sistémicos
    - Hospitalización (no es imprescindible el ingreso) durante más de 12 horas por asma
    E.5.1.1Timepoint(s) of evaluation of this end point
    According to protocol.
    De acuerdo al protocolo
    E.5.2Secondary end point(s)
    The key secondary endpoints are:
    • Proportion of days with nocturnal awakenings due to asthma requiring SABA rescue medication during the 14 days eDiary recording every 4 months after randomisation
    • The average daily dose of SABA during the 14 days eDiary recording every 4 months after randomisation
    • Percentage predicted FEV1 assessed every 4 months after randomisation

    Additional secondary efficacy endpoints are:
    • Time to first clinically relevant asthma exacerbation
    • Time to recurrent clinically relevant asthma exacerbation
    • Rate of severe asthma exacerbation during the efficacy period (period 4), defined as asthma worsening leading to at least one of the following criteria:
    o Systemic corticosteroids for treatment of asthma symptoms for at least 3 days
    o Emergency room visit due to asthma, requiring systemic corticosteroids
    o Hospitalisation (admission not required) for more than 12 hours due to asthma
    • Time to first severe asthma exacerbation
    • Time to recurrent severe asthma exacerbations
    • ACQ or ACQ-IA
    Endpoints derived from the two week daily diary collected every 4 months after treatment initiation include:
    • The average TCRS (TCRS is the sum of the rhinitis daily symptom score (DSS) and the rhinitis daily medication score (DMS)).
    • Average rhinitis DSS
    • Average rhinitis DMS
    • Average rhinoconjunctivitis total combined score (TCS)
    • Average rhinoconjunctivitis DSS
    • Average rhinoconjunctivitis DMS
    • The average combined symptom and medication score (CSMS)
    • Average asthma DSS
    • Global evaluation of allergic asthma
    • Global evaluation of AR
    Los criterios secundarios de valoración clave son:
    - Porcentaje de días con despertares nocturnos por asma que precisen medicación de rescate con agonistas Beta2 de acción corta durante los 14 días de registro en el eDiary cada 4 meses después de la aleatorización
    - Dosis diaria promedio de agonistas Beta2 de acción corta durante los 14 días de registro en el eDiary cada 4 meses después de la aleatorización
    - Porcentaje del FEV1 predicho, en evaluación cada 4 meses después de la aleatorización

    Los criterios secundarios adicionales de valoración de la eficacia son:
    - Tiempo hasta la primera exacerbación asmática clínicamente relevante
    - Tiempo hasta la aparición de exacerbaciones asmáticas clínicamente relevantes recurrentes
    - Tasa de exacerbaciones asmáticas severas durante el periodo de eficacia (periodo 4), que se definen como el deterioro del asma que resulta en como mínimo uno de los siguientes criterios:
    o Corticosteroides sistémicos para el tratamiento de los síntomas asmáticos durante como mínimo 3 días
    o Visita a Urgencias por asma que precisó corticosteroides sistémicos
    o Hospitalización (no es imprescindible el ingreso) durante más de 12 horas por asma
    - Tiempo hasta la primera exacerbación asmática severa
    - Tiempo hasta la aparición de exacerbaciones asmáticas severas recurrentes
    - ACQ o ACQ-IA
    Los criterios de valoración derivados de los datos recogidos todos los días en el diario durante dos semanas cada 4 meses después del inicio del tratamiento son:
    - Promedio de TCRS (TCRS es la suma de la puntuación diaria de síntomas de rinitis (daily symptom score, DSS) y de la puntuación diaria de medicación para la rinitis (daily medication score, DMS)).
    - Promedio de DSS de la rinitis
    - Promedio de DMS de la rinitis
    - Promedio de puntuación combinada total (total combined score, TCS) de la rinoconjuntivitis
    - Promedio de DSS de la rinoconjuntivitis
    - Promedio de DMS de la rinoconjuntivitis
    - Promedio de puntuación combinada de síntomas y de medicación (combined symptom and medication score, CSMS)
    - Promedio de DSS del asma
    - Evaluación global del asma alérgica
    - Evaluación global de la rinitis alérgica
    E.5.2.1Timepoint(s) of evaluation of this end point
    According to protocol.
    De acuerdo al protocolo
    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 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 trial2
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Denmark
    France
    Germany
    Hungary
    Poland
    Russian Federation
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LPLV
    Ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    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: 600
    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.1.1.5.1Number of subjects for this age range: 270
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 330
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children in age range 5-17 years.
    Niños de 5 a 17 años
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 600
    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)
    After the end of the trial, the investigator must advise trial subjects on access to appropriate and available treatment. Such treatment will not be sponsored by ALK.
    Después del final del ensayo, el investigador deberá informar a los pacientes del ensayo acerca del acesso a los tratamientos approbados y disponibles. Estos tratamientos no estarán patrocinados por ALK.
    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 Decision2017-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-04
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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