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    Summary
    EudraCT Number:2007-004071-19
    Sponsor's Protocol Code Number:CQAB149B2331
    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:2007-12-27
    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 number2007-004071-19
    A.3Full title of the trial
    Estudio fase III, multicéntrico, aleatorizado, cruzado, doble ciego, doble enmascaramiento, de dosis múltiple, con 3 periodos de bloques incompletos y controlado con placebo para determinar el efecto de indacaterol (150 y 300 µg o.d.) en la función pulmonar en pacientes con EPOC de moderada a grave, usando tiotropio (18 µg o.d.) como control activo
    A.4.1Sponsor's protocol code numberCQAB149B2331
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Farmacéutica
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameIndacaterol
    D.3.2Product code QAB149
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNIndacaterol
    D.3.9.2Current sponsor codeQAB149
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 nameIndacaterol
    D.3.2Product code QAB149
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNIndacaterol
    D.3.9.2Current sponsor codeQAB149
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 SPIRIVA ®
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International 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.3.1Product nameTiotropium
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNTitropium bromide
    D.3.9.1CAS number 139404-48-1
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder
    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
    Enfermedad pulmonar obstructiva crónica (EPOC)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar si indacaterol (150 µg o.d. y/o 300 µg o.d) es superior a placebo en cuanto al FEV1 valle de 24 horas postdosis después de 14 días de tratamiento en cada periodo de tratamiento en pacientes con EPOC.
    E.2.2Secondary objectives of the trial
    - Determinar si indacaterol (150 µg o.d. y/o 300 µg o.d) es al menos no inferior a tiotropio 18 µg o.d en cuanto al FEV1 valle de 24 horas postdosis después de 14 días de tratamiento en cada periodo de tratamiento en pacientes con EPOC.
    - Evaluar los efectos de indacaterol (150 µg o.d. y 300 µg o.d) y tiotropio (18 µg o.d.) en cuanto al efecto pico y el tiempo hasta el nivel de efecto pico según determina el FEV1 el día 1 de tratamiento en cada periodo de tratamiento.
    - Evaluar el área bajo las curvas del tiempo del FEV1 (0-24 horas) el día 1 y el día 14 en cada periodo de tratamiento.
    - Evaluar los efectos de indacaterol y tiotropio en cuanto al FEV1 valle de 24 horas postdosis después de 1 día de tratamiento en cada periodo de tratamiento.
    En cada tiempo programado de cada periodo de tratamiento se realizará una comparación del tratamiento para FEV1.
    - Evaluar la seguridad de indacaterol en cuanto a constantes vitales, glucosa y potasio, ECG y acontecimientos adversos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hombres y mujeres adultos de edad  40 años, que hayan firmado el formulario de consentimiento informado antes de iniciar cualquier procedimiento relacionado con el estudio.
    2. Pacientes ambulatorios cooperadores con un diagnóstico de EPOC (de moderada a grave de acuerdo con las Guías GOLD, 2006) y:
    a) Antecedentes de consumo de tabaco de al menos 10 paquetes año (fumadores activos o exfumadores).
    b) FEV1 postbroncodilatador < 80% y ≥ 30% del valor teórico normal.
    c) FEV1/FVC postbroncodilatador < 70%.
    (Post se refiere a entre 15 y 30 minutos después de la inhalación de 400 µg de salbutamol en la visita 1).
    E.4Principal exclusion criteria
    1.Mujeres embarazadas o en periodo de lactancia,2.Mujeres potencialmente fértiles 3.Pacientes que hayan sido hospitalizados por una exacerbación de la EPOC en las 6 semanas previas a la visita 1 o durante el periodo de inclusión.4.Pacientes que precisen oxigenoterapia de larga duración (> 15 horas al día) para hipoxemia crónica
    5.Pacientes que hayan presentado infección del tracto respiratorio durante las 6 semanas previas a la visita 1. 6.Pacientes con enfermedad pulmonar concomitante.7.Pacientes con una historia (hasta e incluyendo la visita 1) en los que se incluye a todos los pacientes con:Recuento de eosinófilos en sangre > 400/mm3, Inicio de síntomas de asma antes de los 40 años de edad. 8.Pacientes con diabetes Tipo I o diabetes Tipo II no controlada en los que se incluyen pacientes con antecedentes de concentraciones de glucosa en sangre que están claramente fuera del rango normal o HbA1c > 8,0% de la Hb total determinada en la visita 1.9.Pacientes con contraindicaciones para el tratamiento de tiotropio que incluyen hipertrofia prostática sintomática, obstrucción del cuello de la vejiga o glaucoma de ángulo estrecho. 10.Pacientes que, a criterio del investigador o del equipo responsable de Novartis, tengan una anomalía de laboratorio clínicamente relevante o una afección clínicamente significativa11.Cualquier paciente con cáncer de pulmón o antecedentes de cáncer de pulmón. 12.Cualquier paciente con cáncer activo o antecedentes de cáncer con menos de 5 años de tiempo de supervivencia libre de enfermedad 13.Pacientes con antecedentes de síndrome QT largo, o cuyo intervalo QTc (fórmula de Bazett) medido en la visita 1 o en la visita 3 esté prolongado: > 450 ms (hombres) o > 470 ms (mujeres) tal y como es evaluado según la interpretación del ECG central (visita 1) o según la interpretación de los ECG predosis (visita 3) por parte del investigador. 14.Pacientes con antecedentes de hipersensibilidad a alguno de los fármacos del estudio o a fármacos con estructuras químicas similares. 15.Pacientes que no mantengan ciclos regulares día/noche.16.Pacientes que hayan recibido tratamiento con otros fármacos en investigación en el momento de la inclusión, o en un plazo de 30 días o 5 semividas, previas a la visita 1, cualquiera que sea el periodo más largo. 17.Pacientes que hayan recibido vacunas vivas atenuadas durante los 30 días previos a la visita 1 o durante el periodo de inclusión (se acepta la vacuna de la gripe inactivada siempre que no se administre durante las 48 horas previas a la visita 1). 18.Tratamientos para la EPOC y afecciones relacionadas: las siguientes medicaciones no deben ser utilizadas antes de la visita 1, durante al menos el periodo de lavado mínimo que se especifica a continuación o en cualquier momento durante el estudio (con la excepción de tiotropio administrado como fármaco del estudio durante los periodos de tratamiento):
    a)El anticolinérgico de larga duración tiotropio: 7 días, b)Anticolinérgicos de corta duración: 8 horas, c) Combinaciones fijas de b2 agonistas y corticosteroides inhalados: 48 horas,d) Combinaciones fijas de anticolinérgicos de corta duración y b2 agonistas de corta duración: 8 horas. e)b2 agonistas de larga duración: 48 horas.
    f)b2 agonistas de corta duración (aparte de los prescritos en el estudio): 6 horas.g)Teofilina y otras xantinas: 1 semana. h) Corticosteroides parenterales u orales: 1 mes.19.No deberán utilizarse las siguientes medicaciones a menos que se hayan estabilizado:a)Corticosteroides inhalados o nasales – al menos un mes antes de la visita 1.b)Antihistamínicos (excluyendo los que aparecen en el punto 20c) – al menos 5 días antes de la visita 1.20.Otras medicaciones excluidas:a)Diuréticos no ahorradores de potasio (a menos que se administren como combinación a dosis fija con un diurético ahorrador de potasio). b) Agentes beta-bloqueantes sistémicos. c)Anti-arrítmicos cardiacos de Clase Ia (p. ej., disopiramida, procainamida, quinidina), Clase III (p. ej., amiodarona, dofetilida, ibutilida, sotalol). Terfenadina, astemizol, mizolastina y cualquier otro fármaco con capacidad para prolongar de forma significativa el intervalo QT. d) Antidepresivos tricíclicos e inhibidores de la monoamino-oxidasa. [Fluoxetina o cualquier otro inhibidor selectivo de la recaptación de serotonina, puede ser permitido únicamente si la pauta de tratamiento del paciente ha sido estable durante al menos 1 mes antes de la visita 1; los pacientes presentan un ECG normal en la visita 1 y no hay evidencia clínica de anomalías previas del ECG].e) Cromoglicato, nedocromilo, ketotifeno y antagonistas del leucotrieno. 21.Pacientes incapaces de utilizar de forma adecuada un dispositivo inhalador de polvo seco, MDI o de realizar las determinaciones de la espirometría.
    22.Pacientes con antecedentes conocidos de no-cumplimiento con la medicación o que sean incapaces o no deseen completar un Diario del Paciente.
    E.5 End points
    E.5.1Primary end point(s)
    Determinar si indacaterol (150 µg o.d. y/o 300 µg o.d) es superior a placebo en cuanto al FEV1 valle de 24 horas postdosis después de 14 días de tratamiento en cada periodo de tratamiento en pacientes con EPOC.
    [El FEV1 valle se define como la media de las determinaciones del FEV1 a las 23 horas 10 min. y 23 horas 45 min. después de la dosis del día 14 medidas en la mañana del día 15 en cada periodo 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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    double dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    La finalización del estudio será cuando todos los pacientes randomizados hayan completado el estudio o discontinuado prematuramente.
    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 months6
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 148
    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 Decision2008-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
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