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    Summary
    EudraCT Number:2009-016757-18
    Sponsor's Protocol Code Number:CCD-0807-PR-0024
    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:2011-09-02
    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 number2009-016757-18
    A.3Full title of the trial
    A phase III, 12-week, multicentre, multinational, randomised, double-blind, double-dummy, 3 arm-parallel group study to test the efficacy of CHF 1535 50/6 ?g (fixed combination of beclomethasone dipropionate plus formoterol fumarate) versus a free combination of beclomethasone dipropionate 50 ?g plus formoterol fumarate 6 ?g and versus a monotherapy of beclomethasone dipropionate 50 ?g in partly controlled asthmatic children
    Estudio de fase III, multicéntrico, multinacional, aleatorizado, doble ciego, doble enmascarado, de 3 grupos paralelos, de 12 semanas de tratamiento para evaluar la eficacia de CHF 1535 50/6 µg (combinación fija de dipropionato de beclometasona más fumarato de formoterol) en comparación con una combinación libre de dipropionato de beclometasona 50 µg más fumarato de formoterol 6 µg y en comparación con una monoterapia de dipropionato de beclometasona 50 µg en niños asmáticos parcialmente controlados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multinational Clinical Trial of 12 weeks of duration to test the efficacy of a new drug called CHF 1535 50/6 (fixed combination of a corticoteroid and a long-acting Beta 2 agonist) compared to a free combination of the same substances, and to the corticosteroid only in asthmatic children
    Ensayo Clínico multinacional de 12 semanas de duración para probar la eficacia de un nuevo fármaco llamado CHF 1535 50 / 6 (combinación fija de un corticosteroide y un agonista Beta 2 de acción prolongada) en comparación con una combinación libre de las mismas sustancias y con solo el corticosteriode en niños asmáticos
    A.4.1Sponsor's protocol code numberCCD-0807-PR-0024
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/88/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorChesi Farmaceutici SpA
    B.1.3.4CountryFrance
    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 supportChiesi Farmaceutici SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChiesi Farmaceutici SpA
    B.5.2Functional name of contact pointFlorence Zuccaro
    B.5.3 Address:
    B.5.3.1Street Addressavenue Dubonnet 11
    B.5.3.2Town/ cityCourbevoie
    B.5.3.3Post code92407
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)147684812
    B.5.5Fax number+33(0)147684904
    B.5.6E-mailf.zuccaro@chiesifrance.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 nameCHF 1535 50/6 ?g pMDI
    D.3.2Product code CHF 1535 50/6 ?g pMDI
    D.3.4Pharmaceutical form Pressurised inhalation, solution
    D.3.4.1Specific paediatric formulation Yes
    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 INNBECLOMETASONE DIPROPIONATE
    D.3.9.1CAS number 5534-09-8
    D.3.9.2Current sponsor codeBDP
    D.3.9.3Other descriptive nameBECLOMETASONE DIPROPIONATE
    D.3.9.4EV Substance CodeSUB00681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFORMOTEROL FUMARATE
    D.3.9.1CAS number 43229-80-7
    D.3.9.2Current sponsor codeFF
    D.3.9.3Other descriptive nameFORMOTEROL FUMARATE
    D.3.9.4EV Substance CodeSUB02257MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Ventolair® mite 50 ?g pressurised metered-dose inhaler, solution
    D.2.1.1.2Name of the Marketing Authorisation holderIVAX Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Pressurised inhalation, 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 INNBECLOMETASONE DIPROPIONATE
    D.3.9.1CAS number 5534-09-8
    D.3.9.2Current sponsor codeBDP
    D.3.9.3Other descriptive nameBECLOMETASONE DIPROPIONATE
    D.3.9.4EV Substance CodeSUB00681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 ATIMOS 6 mcg pressurised inhalation solution
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Farmaceutici SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Pressurised inhalation, 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 INNFORMOTEROL FUMARATE
    D.3.9.1CAS number 43229-80-7
    D.3.9.2Current sponsor codeFF
    D.3.9.3Other descriptive nameFORMOTEROL FUMARATE
    D.3.9.4EV Substance CodeSUB02257MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    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 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 placeboPressurised inhalation, solution
    D.8.4Route of administration of the placeboInhalation use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPressurised inhalation, 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
    Asthma
    Asma
    E.1.1.1Medical condition in easily understood language
    Asthma
    Asma
    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 14.0
    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 demonstrate that CHF 1535 50/6 ?g pMDI (daily dose: BDP 200 ?g/FF 24 ?g) is superior to the corresponding monotherapy with beclomethasone dipropionate 50 ?g pMDI (daily dose: BDP 200 ?g) and non-inferior relative to the corresponding free combination of beclomethasone dipropionate 50 ?g pMDI (daily dose: BDP 200 ?g) plus formoterol fumarate 6 ?g pMDI (daily dose: FF 24 ?g) (all treatments administered via the AeroChamber Plus? spacer device) in terms of pulmonary function (change from baseline in pre-dose morning FEV1 after a 12-week treatment period) in children patients with ?partly controlled? persistent asthma
    Demostrar que el IDMp de CHF 1535 50/6 µg (dosis diaria: DPB 200 µg/FF 24 µg) es superior a la monoterapia correspondiente al IDMp de dipropionato de beclometasona 50 µg (dosis diaria: DPB 200 µg) y no inferior respecto a la combinación libre correspondiente al IDMp de dipropionato de beclometasona 50 µg (dosis diaria: DPB 200 µg) más IDMp de fumarato de formoterol 6 µg (dosis diaria: FF 24 µg) (todos los tratamientos administrados mediante el dispositivo espaciador AeroChamber Plus?) en términos de función pulmonar (cambio en el estado inicial del VEF1 matinal antes de administrar la dosis, tras un periodo de tratamiento de 12 semanas) en niños con asma persistente "parcialmente controlada".
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of the treatments on additional lung function parameters and on clinical outcome measures;
    - To assess the safety and the tolerability of the administered treatments
    - Evaluar el efecto de los tratamientos sobre parámetros adicionales de la función pulmonar y sobre resultados clínicos;
    - Evaluar la seguridad y la tolerancia de los tratamientos administrados.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained from the parents/legal representatives (according to the local regulation) and written or verbal assent by the patient (when appropriate) prior to any study related procedures.
    For France: only patients registered under a social welfare can be included in the study.
    2. Prepuberal male and female outpatients, aged ? 5 and < 12 years in Tanner stages I and II according to Investigator's assessment.
    3. Clinical diagnosis of asthma (GINA revised 2009) at least six months prior to screening visit.
    4. Evidence of ?partly controlled? asthma during the 2-week run-in period defined as following (GINA revised 2009), i.e. at least one of the following:
    - daytime symptoms more than twice/week,
    - any limitations of activities,
    - any nocturnal symptoms / awakening,
    - need for reliever/rescue treatment more than twice a week.
    5. Treated with inhaled ?2-agonists as required.
    6. Symptomatic asthmatic patients treated with inhaled beclomethasone dipropionate (BDP) up to 400 ?g or equivalent at a stable dose for at least 4 weeks prior to screening visit.
    Equivalence to:
    BDP non-extrafine ? 400 ?g
    BDP extrafine ? 200 ?g
    Budesonide ? 400 ?g
    Ciclesonide ? 320 ?g
    Flunisolide ? 1250 ?g
    Fluticasone ? 500 ?g
    Mometasone ? 400 ?g
    Triamcinolone ?1200 ?g
    Patients under combination ICS-LABA or ICS-LTRA can enter into the study at the corresponding ICS dose, according to GINA guidelines (i.e. maximum 200 ?g of non-extrafine BDP or equivalent).
    7. A documented positive response to the reversibility test, defined as ?FEV1 ? 12% over baseline, 15 minutes after 400 ?g salbutamol pMDI via a Volumatic? spacer device (ATS/ERS taskforce 2005) within 6 months prior to the screening must be provided. If not available, this test must be done at screening.
    8. Forced Expiratory Volume during the first second (FEV1) ? 60% and ? 95% of predicted normal values at the screening visit and at the randomisation visit.
    9. A cooperative attitude/ability and physical capacity to use a pMDI and a spacer device and perform lung functions.
    1. Consentimiento informado por escrito obtenido de los padres / representantes legales (conforme a la regulación local) y conformidad verbal o escrita por parte del paciente (si corresponde) antes de los procedimientos relativos a cualquier estudio.
    Para Francia: solo los pacientes registrados en la seguridad social podrán ser incluidos en el estudio.
    2. Pacientes prepuberales externos de ambos sexos, con edad comprendida entre ? 5 y < 12 años, en etapas I y II de Tanner, conforme a la evaluación del Investigador.
    3. Diagnóstico clínico de asma (revisión GINA en 2009) al menos seis meses antes de la visita de selección.
    4. Indicios de asma "parcialmente controlada" durante el periodo de preinclusión ?run-in? de 2 semanas de duración, definidos del siguiente modo (revisión GINA 2009), es decir, que incluya una de las siguientes:
    - síntomas diurnos más de dos veces a la semana,
    - cualquier limitación de actividad,
    - cualquier síntoma nocturno / despertar,
    - necesidad de un tratamiento de rescate / aliviador más de dos veces a la semana.
    5. Recibe tratamiento de agonistas ?2 inhalados, según sea necesario.
    6. Pacientes asmáticos sintomáticos tratados con dipropionato de beclometasona (DPB) inhalado hasta 400 µg o equivalente, a una dosis estable durante al menos 4 semanas antes de su visita de selección.
    Equivalencia a:
    DPB no extrafino ? 400 µg
    DPB extrafino ? 200 µg
    Budesónida ? 400 µg
    Ciclesonida ? 320 µg
    Flunisolida ? 1250 µg
    Fluticasona ? 500 µg
    Mometasona ? 400 µg
    Triamcinolona ? 1200 µg

    Los pacientes con una combinación ICS-LABA o ICS-LTRA pueden participar en el estudio, a la dosis de ICS correspondiente, conforme a las directrices GINA (es decir, un máximo de 200 µg de DPB no extrafino o equivalente).
    7. Deben presentarse una respuesta positiva documentada a la prueba de reversibilidad, definida como ?VEF1 ? 12% sobre el estado inicial, 15 minutos después del IDMp de salbutamol 400 ?g mediante un dispositivo espaciador Volumatic? (equipo de trabajo de ATS/ERS 2005) en un plazo de 6 meses antes de la selección. Si no está disponible, esta prueba deberá realizarse durante el periodo de selección.
    8. Volumen Espiratorio Forzado durante el primer segundo (VEF1) ? 60% y ? 95% de los valores normales pronosticados durante la visita de selección y la visita de aleatorización.
    9. Una actitud/capacidad de cooperación y una capacidad física para utilizar un IDMp y un dispositivo espaciador y realizar las funciones pulmonares.
    E.4Principal exclusion criteria
    1. Patients with two or more admissions to hospital for asthma exacerbation in the past 12 months or any admission to intensive care ever.
    2. Any concomitant disease requiring additional treatment with systemic glucocorticosteroids.
    3. Regular use of anticholinergics.
    4. Allergy to one component of medications used.
    5. Intolerance or contra-indication to treatment with ?2-agonists and/or inhaled corticosteroids.
    6. Having received an investigational drug within 2 months before the current study.
    7. Patients and/or parents unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments.
    8. Occurrence of acute asthma exacerbations or lower respiratory tract infections in the 4 weeks preceding the screening visit or during the run-in period.
    9. History of cystic fibrosis, bronchiectasis, primary ciliary dyskinesia, bronchopulmonary dysplasia, or previous premature children with less than 36 weeks of gestational age.
    10. History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit).
    11. Diagnosis of restrictive lung disease.
    12. Significant medical history and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient?s safety, compliance, or study evaluations, according to the investigator?s opinion.
    13. QTc interval (Fridericia?s formula) higher than 450 msec (for boys) and 470 msec (for girls) at screening visit and randomisation visit.
    14. Current smokers.
    1. Los pacientes con dos o más ingresos en el hospital debido a una exacerbación asmática en los últimos 12 meses o cualquier ingreso en la unidad de cuidados intensivos en algún momento.
    2. Cualquier enfermedad concomitante que requiriera un tratamiento adicional con glucocorticosteroides sistémicos.
    3. Uso periódico de anticolinérgicos.
    4. Alergia a algún componente de los medicamentos administrados.
    5. Intolerancia o contraindicación al tratamiento con agonistas ?2 y/o corticosteroides inhalados.
    6. Haber sido administrado un fármaco de investigación en un plazo previo de 2 meses al estudio actual.
    7. Pacientes y/o padres que no deseen cumplir el protocolo del estudio o no comprendan la naturaleza y el ámbito del estudio o los posibles beneficios o los efectos no deseados de los tratamientos del estudio.
    8. Presencia de exacerbaciones asmáticas graves o infecciones de las vías respiratorias inferiores en las 4 semanas previas a la visita de selección o durante el periodo de preinclusión ?run-in?.
    9. Historial de fibrosis quística, bronquiectasia, discinesia ciliar primaria, displasia broncopulmonar o haber tenido otros bebés prematuros con menos de 36 semanas de gestación.
    10. Historial de asma casi mortal (Ej. asma frágil, hospitalización por exacerbación asmática en la Unidad de Cuidados Intensivos).
    11. Diagnóstico de una enfermedad pulmonar restrictiva.
    12. Historial médico significativo y/o tratamiento para enfermedades cardíacas, renales, neurológicas, hepáticas, endocrinas, o cualquier anomalía de laboratorio que indique una enfermedad subyacente importante, que pudiera interferir en la seguridad, el cumplimiento o las evaluaciones de estudio del paciente, según la opinión del investigador.
    13. Intervalo QTc (fórmula de Fridericia) superior a 450 ms (para niños) y 470 ms (para niñas) en la visita de selección y la visita de aleatorización.
    14. Fumadores activos.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to end of treatment (Week 12, V5) in pre-dose morning FEV1 (L).
    Cambio del estado inicial hasta el final del tratamiento (Semana 12, V5) del VEF1 matinal antes de administrar la dosis (L).
    E.5.1.1Timepoint(s) of evaluation of this end point
    V2 (week 0) and V5 (week 12)
    V2 (semana 0) y V5 (semana 12)
    E.5.2Secondary end point(s)
    - change from baseline in pre-dose morning FEV1 and FVC at each clinic visit;
    - mean change from baseline in pre-dose morning FEV1 and FVC;
    - change from baseline in pre-dose morning and evening PEF (measured with electronic manual spirometer);
    - change from baseline in daily PEF variability;
    - change from baseline in daytime and night-time asthma symptom scores;
    - change from baseline in percentage of symptom-free days;
    - change from baseline in daytime and night-time use of rescue salbutamol (number of inhalations);
    - change from baseline in percentage of rescue salbutamol-free days;
    - change from baseline in percentage of asthma control days.
    - change from baseline in Standardised Paediatric Asthma Quality of Life Questionnaire (PAQLQ(S)) score;
    - number of asthma exacerbations, number of patients with asthma exacerbations and asthma exacerbation rate;
    - FeNO parameter expressed as percentage of baseline (as explorative evaluation in a subgroup of 10% of patients in pre-selected centres).
    - Adverse events and adverse drug reactions.
    - Heart rate, systolic and diastolic blood pressure in sitting position, pre-dose (V1 to V5) and 30 min post-dose at each visit (V2 to V5).
    - Standard haematology and blood chemistry at V2 and V5.
    - 12-lead ECG (including QTc interval corrected by Fridericia?s formula), pre-dose at V1, pre-dose and 30 min post-dose at V2 and V5.
    - 12-hour overnight urinary free cortisol/creatinine ratio at V2 and V5.
    - cambio desde el estado inicial del VEF1 matinal antes de administrar la dosis al FVC en cada visita clínica;
    - cambio medio desde el estado inicial del VEF1 matinal antes de administrar la dosis al FVC;
    - cambio desde el estado inicial del PEF matinal y vespertino antes de administrar la dosis (medido con el espirómetro manual electrónico);
    - cambio desde el estado inicial de la variabilidad del PEF;
    - cambio desde el estado inicial de la puntuación de los síntomas de asma diurnos y nocturnos.
    - cambio desde el estado inicial en porcentaje de días sin síntomas;
    - cambio desde el estado inicial del uso diurno y nocturno de salbutamol de rescate (número de inhalaciones).
    - cambio desde el estado inicial en porcentaje de días sin salbutamol de rescate;
    - cambio desde el estado inicial en porcentaje de días de asma controlada;
    - cambio desde el estado inicial en la puntuación del Cuestionario Normalizado de Calidad de Vida para Niños con Asma (PAQLQ(S));
    - número de exacerbaciones asmáticas, número de pacientes con exacerbaciones asmáticas e índice de exacerbaciones asmáticas;
    - parámetro FeNO expresado como porcentaje del estado inicial (como evaluación explorativa en un subgrupo de un 10% de pacientes en centro preseleccionados).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy end points will be evaluated at study visits according to the schedule of assessment reported in the study protocol.
    PAQLQ, Routine haematology and blood chemistry and FeNO test will be evaluated at V2 (week 0) and V5 (week12).
    12-lead ECG will be evaluated at V1 (week -2), V2 (week 0) and V5 (week 12)
    Variables secundaria de eficacia serán evaluadas en las visitas de estudio de acuerdo con el calendario de evaluaciones o pruebas registrados en el protocolo del estudio.
    PAQLQ, hematología y química sanguínea de rutina y prueba de FeNO serán evaluados en V2 (semana 0) y V5 (semana 12).
    ECG de 12 derivaciones será evaluado en V1 (semanas -2), V2 (semana 0) y V5 (semana 12)
    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.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 Yes
    E.8.1.7.1Other trial design description
    doble enmascarado
    double dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA79
    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
    Russian Federation
    Ukraine
    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
    Last Visit of the Last Subject
    La última visita del último sujeto
    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 months2
    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 months2
    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 Yes
    F.1.1Number of subjects for this age range: 700
    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: 700
    F.1.1.6Adolescents (12-17 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The participants are under age and are not allowed to decide partricipation themselves. Parents must consent if the child verbally and bodily agree
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 700
    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 participation in the trial the subjects will be treated according to the standard treatment care expected for their condition
    Después de la participación en el ensayo los sujetos serán tratados de acuerdo con el tratamiento estándar esperado para su condición
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation NETSTAP e.V.
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-09-28
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