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    EudraCT Number:2014-005084-32
    Sponsor's Protocol Code Number:D6230C00001
    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:2015-07-31
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-005084-32
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, parallel group, multi-centre Phase IIa study in asthma patients comparing the efficacy and safety of once daily inhaled Interferon beta-1a to placebo, administered for 14 days after the onset of symptoms of an upper respiratory tract infection for the prevention of severe exacerbations
    Ensayo de fase IIa, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos, en pacientes asmáticos, para comparar la eficacia y la seguridad de interferón beta-1a inhalado, una vez al día, con un placebo, administrados durante 14 días después del comienzo de los síntomas de una infección respiratoria de vías altas para la prevención de las exacerbaciones graves
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate if inhaled Interferon beta-1a is safe, and could prevent or reduce the severity of asthma attacks when administered to asthma patients at the onset of a virus affecting their airways (e.g. common cold or influenza)
    Un estudio para investigar si la inhalación de Interferon beta-1a es segura, y si podría prevenir o reducir la severidad de los ataques de asma cuando se administra en pacientes en el inicio de un virus que afecta a sus vías respiratorias ( por ejemplo, resfriado común o gripe)
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD6230C00001
    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 SponsorAstraZeneca AB
    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 supportAstraZeneca AB
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmacéutica Spain, S.A.
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache, 56; Parque Norte
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.4Telephone number0034900200444
    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 nameInterferon beta-1a Nebuliser solution 48 ?g/mL
    D.3.2Product code Interferon beta-1a Nebuliser solution 48 ?g/mL
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInterferon beta-1a
    D.3.9.1CAS number 145258-61-3
    D.3.9.2Current sponsor codeInterferon beta-1a
    D.3.9.3Other descriptive nameIFN beta-1a
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number48
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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 placeboNebulisation solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term 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
    To evaluate the efficacy of inhaled Interferon beta-1a compared to placebo in preventing severe exacerbations during the 14 days of treatment following onset of an upper respiratory tract infection in asthmatic patients, on top of their regular asthma maintenance treatment.
    Evaluar la eficacia del interferón beta-1a inhalado, en comparación con un placebo, para prevenir exacerbaciones graves durante los 14 días de tratamiento tras el comienzo de una infección de las vías respiratorias altas en pacientes asmáticos, sumado a su tratamiento de mantenimiento del asma habitual.
    E.2.2Secondary objectives of the trial
    To evaluate the preventive or attenuating effect of inhaled Interferon beta-1a compared to placebo on deterioration of secondary efficacy endpoints during and after upper respiratory tract infection. Analysed variables will include:
    - Occurrence of severe exacerbations with onset during day 1-30 after start of treatment
    - Occurrence of moderate exacerbations with onset during day 1-30 after start of treatment
    - Time to severe exacerbation
    - Time to moderate exacerbation
    - Change from treatment baseline in Patient reported outcomes
    - (a) Asthma control as measured by ACQ-6
    - (b) Day-time and night-time asthma symptom score and night-time awakenings as determined by area under the curve (AUC) over day 1-14
    - (c) Health-related quality of life as measured by AQLQ(S)
    - Day-time and night-time reliever medication use as determined by AUC over day 1-14 as change from the treatment baseline level
    - Lung function, ie morning and evening PEF and FEV1
    Evaluar el efecto preventivo o atenuante del interferón beta-1a inhalado, en comp. con placebo, del deterioro de los crit. de valorac. de la efic. secund. durante y desp. de una infecc. de las vías resp. altas. Las vbles analiz.:
    -Aparición de exacerb. graves iniciadas durante los días 1-30 después del inicio del tto.
    -Aparición de exacerb. moderadas iniciadas durante los días 1-30 después del inicio del tto.
    -Tiempo hasta la exacerb. grave.
    -Tiempo hasta la exacerb. moderada.
    -Cambio de los result. comunic. por los ptes respecto al momento basal del tto.
    (a)El control del asma,medido por el ACQ-6
    (b)La puntuación de los sínt.diurnos y nocturnos de asma y los despertares nocturnos,determ. mediante el AUC durante los días 1-14.
    (c)La calidad de vida relacionada con la salud, medida por el AQLQ[S].
    -Uso diurno y nocturno de med.de rescate,deter. mediante el AUC durante los días 1-14 como el cambio respecto al nivel basal con el tto.
    -Función pulmonar,es decir,el PEF,el FEV1.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study patients should fulfil the following criteria:

    1.Provision of signed and dated written informed consent prior to any study specific procedures

    2.Male or female aged 18 and above at the time of screening

    3.History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250 ?g fluticasone dry powder formulation equivalents total daily dose, as defined in GINA 2014; see Appendix Chapter 5) and a second controller medication (eg, LABA or leukotriene receptor antagonist). The medium or high dose ICS plus LABA can be any combination inhaler or 2 separate inhalers. Patients must have taken ICS (>250 ?g fluticasone or the equivalent daily) plus second controller medication for at least 12 months prior to the date the informed consent is obtained, with or without another controller such as OCS, theophylline, tiotropium, or leukotriene receptor antagonists

    4.Proof of post-bronchodilator reversibility in FEV1 of ?12% and ?200 mL (Pellegrino et al 2005) documented within 5 years prior to Visit 1, or proof of a positive response to a methacholine or histamine challenge (a decrease in FEV1 by 20% [PC20] at ?8 mg/mL) performed according to ATS/ERS guidelines (American Thoracic Society 2000) documented within 5 years prior to Visit 1. If historical documentation is not available, reversibility or proof of a positive response to a methacholine challenge must be demonstrated and documented at Visit 1

    5.Must answer ?Yes? to the question ?Does a cold or flu make your asthma worse??

    6.To have had at least two documented severe asthma exacerbations within the last
    24 months that were suspected by the patient to have been caused by a cold or flu
    To have had at least one documented severe asthma exacerbation within the last
    12 months that was suspected by the patient to have been caused by a cold or flu

    A severe asthma exacerbation is defined as worsening of asthma symptoms and:

    -Use of systemic corticosteroids (or a temporary increase of at least 2-fold in a stable oral corticosteroid background dose) for at least three days and/or

    - An unscheduled visit or emergency room visit due to asthma symptoms that requires at least one dose of systemic corticosteroids and/or

    - An in-patient hospitalization due to asthma requiring at least one dose of systemic corticosteroids

    The below defines what is acceptable to document exacerbations in this study:

    - Discharge summaries from a hospital, emergency department, or an urgent care facility indicating that a subject was hospitalized/treated with systemic steroids for an asthma exacerbation.

    - Signed and dated notes from a referring physician, including information regarding diagnosis and treatment of an exacerbation with systemic steroids.

    -Patients can provide evidence of prescriptions for systemic steroids used during an exacerbation.

    -A documented conversation between the treating/referral physician or nurse/nurse practitioner certifying that a patient was treated for an exacerbation with steroids at their clinic or under their supervision. The dates (month/year)
    of the exacerbations and verbal confirmation that appropriate prescriptions
    were provided is necessary. This option should be used only if reasonable attempts to procure patient records have been unsuccessful.

    A combination of the above is acceptable to document the two required exacerbations. However, it is necessary for the Investigator to document how they obtained confirmation of the patient?s asthma exacerbations. It is the Investigator?s responsibility to ensure patient eligibility into the clinical study. In cases where the Investigator feels that alternative records to the above constitutes acceptable documentation, the Study Physician will be contacted for their assessment of eligibility prior to enrolment. Every attempt should be made to obtain appropriate source documentation of medical records.

    7.Negative pregnancy test (urine) for female patients of childbearing potential to communicate well with the Investigator and be capable of understanding the nature of the research and its treatment including its risks and benefits

    9.Ability to read and write and use the electronic devices

    For participation in the optional genetic research

    10.Provision of signed and dated written informed consent for optional genetic research. If a patient declines to participate in the optional exploratory genetic research there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study
    Para participar en el ensayo, los pacientes deben cumplir los crit. siguientes:
    1.Entrega del consentimiento inf. por escrito, firmado y fechado, antes de realizar cualquier procedimiento específ. del ensayo
    2.Varón o mujer de 18 o más años de edad en el momento del reclutamiento
    3.Antecedentes de asma diagnostic. por un médico que exige tto con CI en dosis medias o altas (dosis diaria total equivalente a >250 ?g de formulación de fluticasona en polvo seco, según la definición en GINA 2014; véase el capítulo 5 del apéndice) y una segunda medic. de control (p. ej., ABAP o antagonista de receptores de leucotrienos). El CI en dosis media o alta y el ABAP pueden darse en un inhalador combinado o en dos separados. Las pacientes deberán haber tomado CI (>250 ?g de fluticasona o su equivalente diarios) más la segunda medic. de control durante al menos 12 meses antes de la fecha de obtención del consent. inf., con o sin otro fármaco de control como corticosteroides orales (CO), teofilina, tiotropio o antagonistas de los receptores de leucotrienos.
    4.Demostración de reversibilidad tras el broncodilatador en la FEV1 de > o =12 % y > o =200 ml (Pellegrino y cols., 2005) documentada en los 5 años previos a la visita 1, o demostración de una respuesta positiva a provocación con metacolina o histamina (descenso de la FEV1 del 20 % [CP20] con < o =8 mg/ml) realizada de acuerdo con las pautas de la ATS/ERS (American Thoracic Society 2000) documentada en los 5 años previos a la visita 1. Si no se dispone de documentación histórica, deberá demostrarse y documentarse en la visita 1 la reversibilidad o la respuesta positiva a una provocación con metacolina.
    5.Deberá contestar "Sí" a la pregunta "¿Empeora su asma por un resfriado o la gripe?".
    6.Aparición de al menos dos exacerb. graves del asma document. en los últimos 24 meses que el paciente sospechó que habían sido causadas por un resfriado común o la gripe y Aparición de al menos una exacerb. grave del asma documentada en los últimos 12 meses que el paciente sospechó que había sido causada por un resfriado común o la gripe.
    Una exacerb. grave del asma se define como el empeoramiento de los síntomas del asma y:
    - El uso de corticosteroides sistémicos (o un aumento temporal al menos al doble de una dosis de base de corticosteroides orales estable) durante al menos tres días y/o
    - Una visita no programada o una visita a urgencias debida a sínt. de asma que exige al menos una dosis de corticosteroides sistémicos y/o
    - Una hospitaliz. a causa del asma que exige al menos una dosis de corticosteroides sistémicos
    Se define a continuación lo que es aceptable para documentar las exacerb. en este estudio:
    - Los resúmenes de alta de un hospital, servicio de urgencias o centro asistencial de urgencia que indiquen que se hospitalizó/trató con esteroides sistémicos a un sujeto por una exacerb. del asma.
    - Las notas firmadas y fechadas de un médico remitente, incluida la información sobre el diagnóstico y el tto de una exacerb. con esteroides sistémicos.
    - Los pacientes pueden aportar pruebas de prescripciones de esteroides sistémicos utilizados durante una exacerb.
    - Una conversación documentada entre el médico a cargo o remitente o la enfermera que certifique que se trató a un paciente por una exacerb. con esteroides en su centro o bajo su supervisión. Se necesitan las fechas (mes/año) de las exacerb. y la confirmación verbal de que se entregaron las prescripciones apropiadas. Esta opción sólo debe usarse si no han tenido éxito los intentos razonables de obtener los registros de los pacientes.
    Es aceptable una combinación de los anteriores para documentar las dos exacerbaciones exigidas. No obstante, es preciso que el investigador haga constar cómo obtuvo la confirmación de las exacerbaciones del asma del paciente. El investigador es responsable de asegurarse de la elegibilidad del paciente para el estudio clínico. En los casos en que el investigador considere que registros alternativos a los anteriores suponen una document. aceptable, se contactará con el médico del estudio para que valore la elegibilidad antes del reclutamiento. Debe hacerse todo lo posible para obtener documentación original apropiada de los registros médicos.
    8.Prueba de embarazo (en orina) negativa en las mujeres en edad fértil.
    9.Motivación (en opinión del investigador) para acudir a todas las visitas del estudio y capacidad para comunicarse bien con el investigador y comprender la naturaleza de la investigación y su tratamiento, incluidos sus riesgos y efectos beneficiosos.
    10. Capacidad para leer y escribir y utilizar los dispositivos electrónicos.
    Para la participación en la investigación genética opcional
    11. Consentimiento informado por escrito firmado y fechado para la investigación genética opcional. Si un paciente se niega a participar en la investigación genética exploratorio opcional, no será penalizado ni perderá sus beneficios. Tampoco se le excluirá de otros aspectos del ensayo.
    E.4Principal exclusion criteria
    Patients should not enter the study if any of the following exclusion criteria are fulfilled:
    1.Involvement in the planning and/or conduct of the study (applies to both
    AstraZeneca staff and staff at third party vendors or staff at the study sites)
    2.Previous randomization to treatment in the present study
    3.Any condition, including findings in the medical history or in the pre-study assessments that, in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the patient in the study or that could interfere with the study objectives, conduct or evaluation
    4.Lung disease other than asthma (eg, chronic obstructive pulmonary disease, cystic fibrosis, allergic bronchopulmonary aspergillosis)
    5.Patients with ?4 severe exacerbations during the last 12 months that the patient suspected were triggered by something else than an upper respiratory tract infection
    6.Current participation in another clinical trial or participation in a clinical trial where the patient has received a dose of a test product (IMP) within 12 weeks prior to
    entry into the study for small molecules and within 12 months prior to entry into the study for biologicals
    7.Patients who currently have, or have had within the past 3 months, any significant underlying medical condition(s) that could impact interpretation of results eg, infections, haematological disease, malignancy, renal, hepatic, coronary heart disease or other cardiovascular disease, including arrhythmias, endocrinological or gastrointestinal disease
    8.Abnormal vital signs, after at least 10 minutes supine rest, defined as any of the following:
    -In patients > 60 years old, systolic blood pressure <90 mmHg or ?160 mmHg
    -Diastolic blood pressure <50 mmHg or ?100 mmHg
    -HR <45 or >95 beats per minute
    9.Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, as considered by the Investigator, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology (particularly in the protocol defined primary lead) or left ventricular hypertrophy
    10.Prolonged QTcF >450 ms (for both gender) or shortened QTcF <340 ms or family history of long QT syndrome
    11.PR(PQ) interval shortening <120ms (PR<120 ms but >110 ms is acceptable if there is no evidence of ventricular pre-excitation).
    12.PR(PQ) interval prolongation (>240ms), intermittent second or third degree AV
    block, or AV dissociation
    13.QRS duration >120ms including persistent or intermittent bundle branch block
    14.Patients with implantable cardiac defibrillator (ICD) or a permanent pacemaker and patients with symptomatic ventricular and / or atrial tachyarrhythmias
    15.Patients with unstable angina pectoris or stable angina pectoris classified higher than Canadian Cardiovascular Society (CSS) class II or a myocardial infarction or stroke within 6 months
    16.History of hospitalization within 12 months caused by heart failure or a diagnosis of heart failure higher than New York Heart Association (NYHA) class II
    17.History of hypersensitivity to natural or recombinant Interferon beta-1a or to any of the drug preparation excipients
    18.Received any marketed biologic agent (eg, omalizumab) within 12 months or
    5 times the half-life (whichever is the longer) of the agent prior to enrolment
    19.Significant history of depressive disorder or suicidal ideation. Specifically; individuals with current severe depression (ie, a low mood, which pervades all aspects of life and an inability to experience pleasure in activities that formerly were enjoyed); individuals with a past history of depression that required
    hospitalization or referral to psychiatric services in the past 5 years; individuals who
    currently feel suicidal or have attempted suicide in the past
    20.History of epilepsy or seizures after the age of 5 years, other than febrile childhood seizure(s)
    21.History of drug or alcohol abuse within 12 months prior to screening enrolment
    22.Patients who have hepatic serum enzyme levels ?2.5 times the normal range
    23.Positive test for serum hepatitis B surface antigen, hepatitis C antibody, or HIV
    24.Patients with a smoking history of ?20 pack-years (1 pack year = 20 cigarettes smoked per day for one year)
    25.Female who is breast-feeding, pregnant (verified by urine dipstick pregnancy test)
    or intends to become pregnant during the study
    26.Patients who are unable to demonstrate an acceptable spirometry technique
    27.Patients that have previously been included in studies evaluating the investigational medicinal product
    For participation in the optional genetic research
    Any of the following is regarded as a criterion for exclusion from the genetic research:
    28.Previous bone marrow transplant
    29.Non-leukocyte depleted whole blood transfusion within 120 days of the date of the
    PGx sample collection
    No deben entrar en el ensayo los pacientes que cumplan cualquiera de los crit. de excl. sig.:
    1.Particip. en la planif. o la realiz. del ensayo (se aplica tanto al personal de AZ como al de los proveedores terceros o de los ctros de estudio).
    2.Aleatoriz. previas al tto en este est.
    3.Cualquier circunst., incluidos hallazgos en la hist. clínica o en las valorac. previas al estudio, que, en opinión del invest., suponga un riesgo o una contraindic. de la particip. del paciente en el ensayo o pueda interferir en los obj., el desarrollo o la evaluac. del ensayo.
    4.Enf. pulmonar distinta del asma (p. ej., enf. pulm. obstructiva crónica, fibrosis quística, aspergilosis broncopulmonar alérgica).
    5.Pacientes con > o = 4 exacerb. graves durante los últimos 12 meses que el paciente sospechó desencad. por algo distinto de una infecc. resp. alta.
    6.Particip. en curso en otro ensayo clínico o particip. en un ensayo clínicos en el que el paciente haya recibido una dosis de un producto en ensayo (PMI) en las 12 semanas previas a la entrada en el estudio si es una molécula pequeña y en los 12 meses previos a la entrada en el estudio si se trata de un biológico.
    7.Pacientes que tienen, o han tenido en los 3 últimos meses, cualquier proceso médico subyacente imp. que pueda influir en la interpret. de los result.,como infecc., enf.hematológica,proceso maligno, enf. renal,hepática,coronaria o cardiovascular de otro tipo,incluidas arritmias,o enf.endocrinológica o digestiva.
    8.Anomalías de las const. vitales desp. de al menos 10 min. de reposo en tendido supino, a saber:
    En los pacientes de < 60 años, pres. arterial sistólica <90 mm Hg o > o = 150 mm Hg.
    En los pacientes de > 60 años, pres. arterial sistólica <90 mm Hg o > o = 160 mm Hg.
    Pres. arterial diastólica <50 mm Hg o > o = 100 mm Hg.
    FC <45 o >95 latidos por min.
    9.Cualquier anomalía de imp. clínica del ritmo, la conducción o la morfología del ECG en reposo y cualquier anomalía del ECG de 12 derivaciones que el invest.considere que puede interf. en la interpret. de los camb. del intervalo QTc, incluidas la morfología anómala de la onda ST-T (sobre todo en la derivación principal definida en el prot.) o la hipertrofia del ventrículo izdo.
    10.Prolong. del QTcF >450 ms (en ambos sexos) o acortamiento del QTcF <340 ms o antecedentes fam. de síndrome de QT largo.
    11.Acort. del interv.RP(PQ) <120 ms (es aceptable un PR<120 ms pero >110 ms si no hay indicios de preexcitación ventricular).
    12.Prolong. del interv.PR(PQ) (>240 ms), bloqueo AV de segundo o tercer grado intermit. o disociación AV.
    13.Durac.del QRS >120 ms, incluido bloqueo de rama persistente o intermit.
    14.Pacientes con desfibrilador cardíaco implantable (DCI) o marcapasos permanente y pac. con taquiarritmias ventriculares o auriculares sintomáticas.
    15.Pac. con angina de pecho inestable o estable con clasific. sup. a la clase II de la CSS o infarto de miocardio o ictus en los últ.6 meses.
    16.Antec. de hospitaliz. en los últ.12 meses por insuf.cardíaca o un diagnóstico de insuf.cardíaca calif. como sup. a la clase II de la NYHA.
    17.Antec. de hipersensib.al interferón beta-1a natural o recombinante o a cualquier excipiente usado para prep. el fármaco.
    18.Administrac. de cualquier fármaco biológ. comercializ. (p. ej., omalizumab) en los 12 meses o 5 semividas previos (lo que sea mayor) del fármaco antes del reclutamiento.
    19.Anteced. imptes de trastorno depresivo o ideas suicidas. En concreto: personas con depresión intensa en curso (es decir, estado de ánimo bajo que impregna todos los aspectos de la vida y incap. para sentir placer en act. que antes de disfrutaban); personas con antec.de depresión que necesitaron hospitaliz. o remisión a servicios psiquiátricos en los últimos 5 años; personas con tendencia suicida actual o que han intentado suicidarse previam.
    20.Anteced.de epilepsia o crisis convulsivas después de los 5 años de edad (se exceptúan las convulsiones febriles de la niñez).
    21.Anteced. de abuso de abuso de drogas o fármacos o alcohol en los 12 meses previos al reclutamiento.
    22.Pac. con concentraciones séricas de enzimas hepáticas ?2,5 veces sup. al interv.normal.
    23.Prueba + para el antígeno de sup.del virus de la hepatitis B, los antic. contra el virus de la hepatitis C o el VIH.
    24.Pac. con anteced. de tabaquismo de >o=20 paquetes-año (>o=1 paquete-año = 20 cigarrillos fumados al día durante un año).
    25.Mujeres lactantes, embarazadas (com. mediante prueba de embarazo por tira reactiva en orina) o que pretendan quedarse embarazadas durante el estudio.
    26.Pac. incap. de demostrar una técnica espirométrica aceptable.
    27.Pac. incluidos prev. en est. de eva. del mto en invest.,
    Para la particip. en la invest. genética opcional
    Cualquiera de los siguientes se considera crit. de exc. de la invest. genética:
    28.Alotrasplante de médula ósea previo.
    29.Transf. de sangre entera sin depleción de leucocitos en los 120 días previos a la fecha de recogida de muestras para FG.
    E.5 End points
    E.5.1Primary end point(s)
    Number of severe exacerbations (during 14 days of treatment)
    Duration of severe exacerbation
    Número de exacerbaciones graves (durante 14 días de tratamieto)
    Duración de las exacerbaciones graves
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the 14 days of treatment
    Durante 14 días de tratamiento
    E.5.2Secondary end point(s)
    Number of moderate exacerbations (during 14 days of treatment)
    Number of severe exacerbations (during day 1-30 after start of treatment)
    Number of moderate exacerbations (during day 1-30 after start of treatment)
    Time to sever exacerbation
    Time to exacerbation (moderate or severee)

    Change from treatment baseline in Patient reported outcomes in the following variables:
    - Asthma control as measured by ACQ-6
    - Day-time and night-time asthma symptom score and night-time awakenings as determined by area under the curve (AUC) over day 1-14
    - Health-related quality of life as measured by AQLQ(S)

    Day-time and night-time reliever medication use as determined by AUC over day 1-14 as change from the treatment baseline level

    Lung function ie, PEF, FEV1
    Morning and evening peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1) measured daily at home, as determined by AUC over day 1-14 as change from the baseline level
    -Número de exacerbaciones moderadas durante los primeros 14 días de tratamiento.
    -Número de exacerbaciones graves durante los días 7-30 después del inicio del tto.
    -Número de exacerbaciones moderadas durante los días 1-30 después del inicio de tto.
    -Tiempo hasta la exacerb. grave.
    -Tiempo hasta la exacerb. (moderada o grave)
    -Cambio de los result. comunic. por los ptes respecto al momento basal del tto.
    (a)El control del asma,medido por el ACQ-6
    (b)La puntuación de los sínt.diurnos y nocturnos de asma y los despertares nocturnos,determ. mediante el AUC durante los días 1-14.
    (c)La calidad de vida relacionada con la salud, medida por el AQLQ[S].
    -Uso diurno y nocturno de med.de rescate,deter. mediante el AUC durante los días 1-14 como el cambio respecto al nivel basal con el tto.
    -Función pulmonar,es decir,el PEF,el FEV1.
    - El PEF y el FEV1 matinales y nocturnos, medidos a diario en el domicilio, determinados mediante el AUC durante los días 1-14 como el cambio respecto al nivel basal con el tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the 14 days of treatment and for some up to 30 days after start of treatment
    Durante los 14 días de tratamiento y para algunos pacientes hasta 30 días después del inicio del tratamiento
    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 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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    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.8.2.4Number 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Korea, Democratic People's Republic of
    United Kingdom
    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 years1
    E.8.9.1In the Member State concerned months7
    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 months7
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 220
    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)
    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 Decision2015-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-18
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