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    Summary
    EudraCT Number:2013-002483-84
    Sponsor's Protocol Code Number:CNVA237A3401
    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:2013-12-27
    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 number2013-002483-84
    A.3Full title of the trial
    Multicenter, randomized, blinded, two-period cross-over study to assess the effect of glycopyrronium (44 micrograms QD) versus tiotropium (18 micrograms QD) on morning symptoms and pulmonary function in patients
    with moderate to severe COPD.
    Estudio multicéntrico, aleatorizado, ciego y con grupos cruzados y dos
    periodos, para evaluar el efecto de glicopirronio (44 ?g 1 v/d) comparado
    con tiotropio (18 ?g 1 v/d) en los síntomas matinales y la función
    pulmonar en pacientes con EPOC de moderada a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the effect of glycopyrronium versus tiotropium on morning symptoms and pulmonary function in patients with moderate to severe COPD.
    Estudio para evaluar el efecto de glicopirronio frente a tiotropio sobre los síntomas matinales y la función pulmonar en pacientes con EPOC de moderada a grave.
    A.4.1Sponsor's protocol code numberCNVA237A3401
    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 SponsorNovartis Farmacéutica, S. A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S. A.
    B.5.2Functional name of contact pointDepartamento Médico (HOR-MK)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34900353036
    B.5.5Fax number34932479903
    B.5.6E-maileecc.novartis@novartis.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 Yes
    D.2.1.1.1Trade name Seebri Breezhaler
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm, Ltd.
    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 Inhalation powder, hard capsule
    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 INNGLYCOPYRRONIUM BROMIDE
    D.3.9.1CAS number 596-51-0
    D.3.9.2Current sponsor codeNVA237
    D.3.9.4EV Substance CodeSUB07951MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number44
    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 Yes
    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 Spiriva Handihaler
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim
    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 Inhalation powder, hard capsule
    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 INNTiotropium Bromide Monohydrate
    D.3.9.1CAS number 139404-48-1
    D.3.9.4EV Substance CodeSUB21897
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 Yes
    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 placeboInhalation powder, hard capsule
    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 placeboInhalation powder, hard capsule
    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
    Chronic Obstructive Pulmonary Disease (COPD)
    Enfermedad Pulmonar Obstructiva Crónica (EPOC)
    E.1.1.1Medical condition in easily understood language
    COPD is a cronic condition of the lungs which causes people to suffer symtoms such as shortness of breath and coughing.
    La EPOC es un trastorno pulmonar que se caracteriza por la existencia de una obstrucción de las vías aéreas generalmente progresiva y no reversible.
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 100000004855
    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 glycopyrronium QD is superior to tiotropium QD in terms of FEV1 AUC0-4h after first dose of treatment.
    Demostrar que glicopirronio 1 v/d es superior a tiotropio 1 v/d en el AUC 0-4 h del VEF1 después de la primera dosis de tratamiento.
    E.2.2Secondary objectives of the trial
    ? To compare glycopyrronium QD versus tiotropium QD on symptoms, through the PROMorning COPD Symptoms Questionnaire measurement in the morning at 3 hours post
    inhalation on Day 1 and Week 4 of treatment.
    To compare glycopyrronium QD versus tiotropium QD:
    - efficacy in terms of FEV1 AUC0-4h after dose given at 4 weeks of treatment.
    - efficacy in terms of the AUC0-4h for inspiratory capacity (IC) after first dose and after dose given at 4 weeks of treatment.
    - with regard to the IC and forced vital capacity (FVC) after first dose and after dose given at 4 weeks of treatment.
    - with regard to the peak IC value (defined as maximum value within 4 hours post inhalation) after first dose and after dose
    given at 4 weeks of treatment.
    - on activities of daily living after 4 weeks of treatment, measured by the London Chest Activity of Daily Living (LCADL) questionnaire.
    ?Comparar glicopirronio 1 v/d con tiotropio 1 v/d en los síntomas, a través de la puntuación por las mañanas en el cuestionario de PRO de síntomas matinales de la EPOC, 3 horas después de la inhalación el día 1 y en la semana 4 de tratamiento.
    Comparar la eficacia de glicopirronio 1 v/d frente a tiotropio 1 v/d en lo que respecta al:
    - AUC0-4 h del VEF1 después de la dosis administrada a las 4 semanas de tratamiento.
    - AUC0-4 h para la capacidad inspiratoria (CI) después de la primera dosis y después de dosis administrada a las 4 semanas de tratamiento.
    - CI y la capacidad vital forzada (CVF) después de la primera dosis y después de la dosis administrada a las 4 semanas de tratamiento.
    - Valor máximo de la CI (definida como valor máximo en las 4 horas posteriores a la inhalación) después de la primera dosis y después de la dosis administrada a las 4 semanas de tratamiento.
    - Actividades de la vida diaria después de 4 semanas de tratamiento, según el cuestionario LCADL.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who have signed an Informed Consent Form before any assessment is performed.
    2. Male and female adults aged ? 40 years.
    3. Co-operative outpatients with a clinical diagnosis of moderate to severe COPD confirmed by spirometry according to GOLD criteria 2013 and including all of the following:
    a. Current or ex-smokers who have a smoking history of at least 10 pack years (e.g.10 pack years = 1 pack /day x 10 years or ½ pack/day x 20 years). An ex-smoker may be defined as a subject who has not smoked for ? 6 months at Screening.
    b. Patients with airflow limitation indicated by a post-bronchodilator FEV1 < 80% and ? 40% of the predicted normal value at Visit 2 (Post- bronchodilator refers to within 10-
    15 min of inhalation of 400 ?g (4x100 ?g) of salbutamol).
    c. Post-bronchodilator FEV1/FVC < 0.7 at Visit 2 (Post- bronchodilator refers to within 10-15 min of inhalation of 400 ?g (4x100 ?g) of salbutamol).
    4. Patients with a COPD Assessment Test (CAT) score ? 10 at Visit 2.
    1.Pacientes que hayan firmado un formulario de consentimiento informado antes de realizarles cualquier evaluación
    2.Hombres y mujeres adultos de ? 40 años de edad.
    3.Pacientes ambulatorios colaboradores con un diagnóstico clínico de EPOC de moderada a grave confirmado mediante espirometría según los criterios GOLD 2013 y que cumplan todos los criterios siguientes:
    a.Fumadores o exfumadores con antecedentes de tabaquismo de al menos 10 paquetes-años (p. ej., 10 paquetes-años = 1 paquete/día x 10 años o ½ paquete/día x 20 años). Un exfumador podría definirse como una persona que no ha fumado durante ? 6 meses en el momento de la selección.
    b.Pacientes con limitación del flujo de aire indicado por un VEF1 post-broncodilatador < 80 % y ? 40% del valor normal previsto en la visita 2 (post-broncodilatador se refiere a 10 - 15 minutos después de la inhalación de 400 µg [4 x 100 µg] de salbutamol).
    c.VEF1/CVF post-broncodilatador < 0,7 en la visita 2 (post-broncodilatador se refiere a 10-15 minutos después la inhalación de 400 µg [4 x 100 µg] de salbutamol).
    4.Pacientes con una puntuación ? 10 en el Cuestionario de evaluación de la EPOC (CAT) en la visita 2.
    E.4Principal exclusion criteria
    1. Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to Visit 1. In the event of an exacerbation occurring during the Screening period (Visits 1-2), the patient must be discontinued from the study.
    2. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection between Visit 1 and Visit 2 must discontinue from the trial, but may be permitted to re-enrol at a later date once the inclusion/exclusion criteria have been met.
    3. Patients on any long-acting bronchodilator therapy. Those patients may enter the study after bronchodilator withdrawal during a 10-day wash-out period (only rescue salbutamol
    allowed as bronchodilator therapy during wash-out). Patients on fixed combination of long acting ?2-agonists/inhaled corticosteroid (LABA/ICS) therapy before screening must be switched to the equivalent dose of ICS monotherapy and salbutamol as rescue.
    4. Patients receiving any other prohibited COPD-related medications specified in Table 5-1 must undergo the required wash-out period prior to Visit 2.
    5. Patients who have had a clinical history of asthma.
    6. Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis or clinically significant bronchiectasis.
    7. Patients with alpha-1-antitrypsin deficiency.
    8. Patients with contraindications for LAMA treatment including medical history of symptomatic prostatic hypertrophy, bladder neck obstruction, narrow-angle glaucoma and severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2) documented in the previous 6 months.
    9. Patients with a history of unstable cardiovascular disease or arrhythmias including atrial fibrillation/flutter or long QT syndrome or whose resting QTcF (calculated according to Fridericia QT correction formula preferred, but Bazett acceptable) is prolonged (? 450 msec for males and ? 460 msec for females) at screening (Visit 1) or baseline (Visit 2, baseline 1).
    10. Concomitant use of agents known to prolong the QT interval unless it can be permanently discontinued for the duration of study.
    11. Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof:
    ? anticholinergic agents
    ? long and short acting ?2-agonists
    ? sympathomimetic amines
    ? excipients of the trial medication (lactose monohydrate and/or magnesium estearate)
    12. Patients whose body mass index (BMI) is less than 15 or greater than 40 kg/m2.
    13. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
    14. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin (hCG) laboratory test (> 5 mIU/mL).
    15. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods include:
    ? Total abstinence
    ? Female sterilization
    ? Male sterilization
    ? Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository
    ? Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%)
    ? Placement of an intrauterine device or intrauterine system.
    Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been
    confirmed by follow up hormone level assessment is she considered not of child bearing potential.
    16. Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements.
    17. Patients unable to fill a self-questionnaire.
    18. Use of other investigational drugs within 5 half-lives of enrollment or within 30 days, whichever is longer.
    1.Pacientes que han sufrido una exacerbación de EPOC que requiera tratamiento sistémico con glucocorticosteroides o antibióticos y/u hospitalización en las 6 semanas anteriores a la visita 1. En caso de que se produzca una exacerbación durante el periodo de selección (visitas 1 - 2), el paciente será retirado del estudio. Se podrá incluir de nuevo al paciente cuando cumpla los criterios de inclusión/exclusión. Solo se permite volver a someter a los pacientes a los exámenes de selección una vez.
    2.Pacientes que hayan sufrido una infección de las vías respiratorias en las 6 semanas previas a la visita 1. Los pacientes que desarrollen una infección de las vías respiratorias entre la visita 1 y la visita 2 deben interrumpir su participación en el estudio, pero se puede permitir volver a someterlos a los exámenes de selección en una fecha posterior una vez se cumplan los criterios de inclusión/exclusión. Solo se permite volver a someter a los pacientes a los exámenes de selección una vez.
    3.Pacientes que reciban cualquier tratamiento broncodilatador de acción prolongada. Estos pacientes pueden ser incluidos en el estudio después de la retirada del broncodilatador durante un periodo de lavado de 10 días (solo se permite salbutamol de rescate como tratamiento broncodilatador durante el periodo de lavado). A los pacientes en tratamiento de combinación fija de agonistas beta2 de acción prolongada/corticosteroide inhalado (LABA/CSI) antes de la selección se les cambiará a la dosis equivalente de CSI en monoterapia y salbutamol como rescate.
    4.Los pacientes que reciban cualquier otro medicamento relacionado con la EPOC prohibido según se especifica en la Tabla 5-1 deben someterse a un periodo de lavado antes de la visita 2.
    5.Pacientes con antecedentes clínicos de asma.
    6.Pacientes con patologías pulmonares concurrentes, por ejemplo, tuberculosis pulmonar o bronquiectasia clínicamente significativa.
    7.Pacientes con déficit de alfa-1-antitripsina.
    8.Pacientes con contraindicaciones por tratamiento con LAMA incluidos antecedentes médicos de hipertrofia prostática sintomática, obstrucción del cuello vesical, glaucoma de ángulo cerrado o deterioro renal grave (tasa de filtración glomerular estimada inferior a 30 ml/min/1,73 m2) registrado en los últimos 6 meses.
    9.Pacientes con antecedentes de enfermedad cardiovascular inestable o arritmias como fibrilación auricular/aleteo auricular o síndrome de QT prolongado o con un QTcF en reposo (calculada preferentemente conforme a la fórmula del intervalo QT con corrección de Fridericia, aunque Bazett es aceptable) prolongado (? 450 ms en hombres y ? 460 ms en mujeres) en la selección (visita 1) o en el periodo basal (visita 2, periodo basal 1).
    10.Uso concomitante de fármacos conocidos por prolongar el intervalo QT, salvo que pueda suspenderse permanentemente durante todo el estudio.
    11.Pacientes en los que esté contraindicado el tratamiento con cualquiera de los siguientes fármacos inhalados, fármacos de una clase similar o cualquier componente de los mismos, o con antecedentes de reacciones/hipersensibilidad a ellos:
    ?anticolinérgicos
    ?agonistas beta2 de acción corta y prolongada
    ?aminas simpaticomiméticas
    ?excipientes de la medicación del ensayo (lactosa monohidrato y/o estearato de magnesio)
    12.Pacientes con un índice de masa corporal (IMC) inferior a 15 o superior a 40 kg/m2.
    13.Antecedentes de neoplasias malignas en cualquier sistema orgánico (aparte de carcinoma basocelular de piel localizado), tratados o no tratados, en los últimos 5 años, independientemente de que haya indicios de recidiva local o metástasis.
    14.Mujeres embarazadas o en periodo de lactancia, definiéndose el embarazo como el estado de la mujer después de la concepción y hasta el fin de la gestación, confirmado por un resultado positivo (> 5 mUI/ml) en las pruebas analíticas de gonadotropina coriónica humana (hCG).
    15.Mujeres fértiles, definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas, a menos que utilicen métodos anticonceptivos eficaces durante la administración del tratamiento del estudio.16.Pacientes que no puedan utilizar un dispositivo inhalador de polvo seco o realizar mediciones espirométricas.
    17.Pacientes que no sean capaces de rellenar un autocuestionario.
    18.Uso de cualquier otro fármaco en fase de investigación en un plazo de 5 semividas o 30 días antes de la inclusión, lo que sea mayor.
    E.5 End points
    E.5.1Primary end point(s)
    Forced Expiratory Volume in 1 second (FEV1) Area Under Curve (AUC) will measured via spirometry and calculated from 0 to 4 hours post-dose on Day 1 and Week 4 of study treatment.
    El Área bajo la curva (AUC) del Volumen Espiratorio Forzado del primer segundo (FEV1) se calculará de 0 a 4 horas después de la administración el día 1 y la semana 4 de cada uno de los periodos de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The assessment to address the primary objective will be performed at the start of both treatment epochs, i.e. first day of each treatment period (Day 1 and Day 43). All patients will be followed up (by telephone) 30 days after the last administration of study treatment.
    El objetivo principal se evaluará al comienzo de ambos períodos de tratamiento, es decir, el primer día de cada periodo de tratamiento (Día 1 y el Día 43). Todos los pacientes serán objeto de seguimiento (por teléfono) 30 días después de la última administración del tratamiento del estudio.
    E.5.2Secondary end point(s)
    Comparison of symptoms outcome between glycopyrronium QD versus tiotropium QD will be conducted via the PROMorning COPD Symptoms questionnaire. This questionnaire will be completed by participants at waking-up, pre-inhalation of study treatment (at home), and they will complete Part 2 of PRO-Morning COPD Symptoms questionnaire at site, 3hours post-inhalation of study treatment.
    La comparación de resultados entre los síntomas de glicopirronio 1 v/d y tiotropio 1 v/d se llevará a cabo a través del cuestionario PRO de síntomas matinales de la EPOC. Este cuestionario será completado por los participantes al despertar, antes de la inhalación de tratamiento del estudio (en casa), y completarán la Parte 2 del cuestionario de PRO de síntomas matinales de la EPOC en el centro, 3 horas después de la inhalación de tratamiento del estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The comparisons will be performed between results obtained at Day 1 (baseline, V2 and V5) and W4 (V4 and V7, end of treatment) of each treatment line.
    Las comparaciones se realizarán entre los resultados obtenidos el día 1 (VB, V2 y V5) y la semana 4 (V4 y V7, al final del tratamiento) de cada período de 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 No
    E.6.4Safety No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 EEA4
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    When subject leaves the study the investigator will discuss the different medications or possible alternatives that are available to treat the subject´s COPD.
    Cuando el sujeto finalice el estudio el investigador discutirá los diferentes medicamentos o las posibles alternativas que están disponibles para el tratamiento de la EPOC del sujeto.
    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 Decision2014-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-28
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