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    Summary
    EudraCT Number:2011-005673-23
    Sponsor's Protocol Code Number:CNVA237A2316
    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:2012-02-29
    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 number2011-005673-23
    A.3Full title of the trial
    A 12-week multi-center, randomized, double-blind, parallel-group study to assess the efficacy, safety and tolerability of the co-administration of NVA237 + indacaterol once daily vs. indacaterol once daily in patients with moderate to severe COPD
    Estudio de 12 semanas de duración, multicéntrico, aleatorizado, doble ciego y de grupos paralelos para evaluar la eficacia, seguridad y tolerabilidad de la co-administración de NVA237 + indacaterol una vez al día vs. indacaterol una vez al día 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
    Efficacy, safety and tolerability of the co-administration of NVA237 + indacaterol once daily vs. indacaterol once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
    Eficacia, seguridad y tolerabilidad de la co-administración de NVA237 + indacaterol una vez al día vs. indacaterol una vez al día en pacientes con Enfermedad Pulmonar Obstructiva Crónica (EPOC)
    A.3.2Name or abbreviated title of the trial where available
    GLOW6
    GLOW6
    A.4.1Sponsor's protocol code numberCNVA237A2316
    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 Farmacéutica S.A.
    B.4.2CountrySpain
    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 pointInmaculada Bosch Tirau
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number0034933064342
    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 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 nameGlycopyrronium bromide
    D.3.2Product code NVA237
    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.3.9.3Other descriptive nameGlycopyrronium Bromide
    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 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 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
    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 chronic condition of the lungs which causes people to suffer
    symptoms such as shortness of breath and coughing.
    La EPOC es una alteración crónica de los pulmones que provoca que las personas sufran síntomas como falta de aliento y tos.
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    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 the superiority of NVA237 50 µg + indacaterol 150 µg administered once daily as compared with indacaterol 150 µg administered once daily in terms of trough FEV1 at Week 12.
    Demostrar la superioridad de NVA237 50 µg + indacaterol 150 µg administrado una vez al día en comparación con indacaterol 150 µg administrado una vez al día en términos de FEV1 valle en la Semana 12.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of NVA237 50 µg o.d. + indacaterol 150 µg o.d. as compared to indacaterol 150 µg o.d. in terms of:
    ?FEV1 AUC5 min ? 4 h post dosing at Week 12
    ?Peak FEV1 at Week 12 (where peak FEV1 is defined as the maximum FEV1 during the first 4 h post morning dosing)
    ?FEV1, FVC and IC at individual time-points on Day 1, Day 29, Day 57 and Days 84/85
    ?The mean change from baseline in daily number of puffs of rescue medication following 12 weeks of treatment
    ?The focal score of the Transitional Dyspnea Index (TDI) after 12 weeks of treatment
    ?Symptoms reported over 12 weeks of treatment using e-diary
    ?Safety and tolerability
    Evaluar el efecto de NVA237 50 µg o.d. + indacaterol 150 µg o.d. en comparación con indacaterol 150 µg o.d. en términos de:
    ? FEV1 AUC5 min ? 4 h post dosis en la Semana 12
    ? FEV1 pico en la Semana 12 (donde FEV1 pico se define como el FEV1 máximo durante las primeras 4 h post dosis de la mañana)
    ? FEV1, FVC y CI en tiempos individuales el Día 1, Día 29, Día 57 y Días 84/85
    ? El cambio medio desde la basal en el número de inhalaciones diarias de medicación de rescate después de 12 semanas de tratamiento
    ? La puntuación focal del Índice de Disnea Transicional (TDI) tras 12 semanas de tratamiento
    ? Síntomas notificados durante 12 semanas de tratamiento utilizando el e-diario
    ? Seguridad y tolerabilidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female adults aged ?40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
    2. Patients with moderate to severe stable COPD (Stage II or Stage III) according to the current GOLD Guidelines (GOLD, 2010).
    3. Patients with a post-bronchodilator FEV1 ? 30 % and/or <80 % of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at screening.
    [Post-bronchodilator refers to 1 h after sequential inhalation of 84 µg ipratropium bromide (or equivalent dose) and 400 µg salbutamol (or equivalent dose)].
    4. 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).
    5. Symptomatic patients according to daily diary data, between the screening visit (Visit 2) and the randomization visit (Visit 3) with a total symptom score of 1 or more on at least 4 of the last 7 days prior to randomization (Visit 3).
    Other protocol defined inclusion criteria may apply.
    1. Hombres y mujeres adultos con edad ?40 años, que hayan firmado un Formulario de Consentimiento Informado antes de iniciar cualquier procedimiento relacionado con el estudio.
    2. Pacientes con EPOC estable de moderada a grave (Estadio II o Estadio III) según las Normas GOLD actuales (GOLD, 2010).
    3. Pacientes con un FEV1 post-broncodilatador ? 30 % y/o <80 % del valor teórico normal, y un FEV1/FVC post-broncodilatador < 0,70 en la selección.
    [Post-broncodilatador se refiere a 1 h después de la inhalación secuencial de 84 µg de bromuro de ipratropio (o dosis equivalente) y 400 µg de salbutamol (o dosis equivalente)]
    4. Fumadores actuales o ex-fumadores con antecedentes de consumo de tabaco de al menos 10 paquetes-año (10 paquetes años = 1 paquete/día x 10 años, o ½ paquetes/día x 20 años).
    [Un ex-fumador se define como un sujeto que no haya fumado durante ? 6 meses en la selección. Un envase de cigarrillos es igual a 20 cigarrillos].
    5. Pacientes sintomáticos según los datos diarios del diario, entre la visita de selección (Visita 2) y la visita de aleatorización (Visita 3) con una puntuación total de síntomas de 1 o más en al menos 4 de los últimos 7 días previos a la aleatorización (Visita 3).
    E.4Principal exclusion criteria
    1. Pregnant or nursing (lactating) women.
    2. Women of child-bearing potential.
    3. Patients with Type I or uncontrolled Type II diabetes.
    4. Patients with a history of long time interval between start of Q wave and end of T wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart rate (QTc) measured at screening (Visit 2) (Fridericia method) is prolonged
    5. Patients with paroxysmal (e.g. intermittent) atrial fibrillation
    6. Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2)

    Other protocol defined exclusion criteria may apply
    1. Mujeres embarazadas o en periodo de lactancia
    2. Mujeres en edad fértil, definidas como toda mujer fisiológicamente capaz de quedarse embarazada
    3. Pacientes con diabetes Tipo I o Tipo II no controlada.
    4. Pacientes con antecedentes de síndrome QT largo o cuyo QTc determinado en la selección (Visita 2) (método de Fridericia) sea prolongado (>450 mseg para hombres y mujeres) y confirmado por un asesor de ECG central. (Estos pacientes no deben ser re-seleccionados).
    5. Los pacientes con fibrilación auricular paroxística (es decir intermitente) son excluidos.
    6. Los pacientes que tengan una anomalía clínicamente significativa de ECG o analítica en la selección (Visita 2).
    Por favor, referirse al protocolo para ver todos los criterios de exclusión con más detalle.
    E.5 End points
    E.5.1Primary end point(s)
    24 h trough forced expiratory volume in 1 second (FEV1) after 12 weeks.
    La variable principal del estudio será el FEV1 valle tras 12 semanas de tratamiento en pacientes con EPOC de moderada a grave.
    [FEV1 valle se define como el promedio de los valores de los valores de FEV1 post-dosis 23 h 15 min y 23 h 45 min en la Visita 8].
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timeframe: 12 Weeks
    Tiempo: 12 semanas
    E.5.2Secondary end point(s)
    a. Post dose FEV1 Area Under the Curve (AUC)5 min ? 4 h
    b. Peak FEV1
    c. FEV1 at individual time-points
    d. Forced Vital Capacity (FVC) at individual time-points
    e. Inspiratory capacity (IC) at individual time-points
    f. Mean change from baseline in daily number of puffs of rescue medication
    g. Focal score of the Transitional Dyspnea Index (TDI)
    h. Symptoms via patient e-diary
    i. Safety and tolerability
    a. FEV1 AUC5 min ? 4 h post dosis en la Semana 12
    b. FEV1 pico en la Semana 12 (donde FEV1 pico se define como el FEV1 máximo durante las primeras 4 h post dosis de la mañana)
    c. FEV1
    d. Capacidad Vital Forzada
    e. Capacidad Inspiratoria
    FEV1, FVC y CI en tiempos individuales el Día 1, Día 29, Día 57 y Días 84/85
    f. El cambio medio desde la basal en el número de inhalaciones diarias de medicación de rescate después de 12 semanas de tratamiento
    g. La puntuación focal del Índice de Disnea Transicional (TDI) tras 12 semanas de tratamiento
    h. Síntomas notificados durante 12 semanas de tratamiento utilizando el e-diario
    i. Seguridad y tolerabilidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    a. b. Timeframe: 12 Weeks
    c. d. e. Timeframe: Day 1, Day 29, Day 57 and Days 84/85
    f. Timeframe: Baseline and 12 weeks
    g. h. i. Timeframe: 12 weeks
    a. b. Tiempo: 12 semanas
    c. d. e. Tiempo: Dia 1, Día 29, Día 57 y Día 84/85
    f. Tiempo: Basal y 12 semanas
    g. h. i. Tiempo: 12 semanas
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Turkey
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days24
    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: 225
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 225
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 385
    F.4.2.2In the whole clinical trial 450
    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)
    Patients completing the treatment period will not be given further access to study drugs.
    NVA237 is not currently registered for the treatment of COPD and there are other marketed therapeutic alternatives available to treat these patients therefore NVA237 will not be supplied to patients after the completion of the study.
    Los pacientes que completen el periodo de tratamiento no tendrán más acceso a los fármacos. NVA237 no está actualmente registrado para el tratamiento de la EPOC y ya hay disponibles otras alternativas de tratamiento para tratar a estos pacientes. NVA237 no será proporcionado a los pacientes después de que completen el ensayo.
    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 Decision2012-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-08
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