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    Summary
    EudraCT Number:2008-005146-23
    Sponsor's Protocol Code Number:CQAB149B2349
    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:2009-01-20
    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 number2008-005146-23
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, doble ciego, doble enmascarado, con grupos paralelos de 12 semanas de tratamiento para evaluar la superioridad de indacaterol (150 µg o.d.) administrado mediante SDDPI en pacientes con EPOC de moderada a grave, usando salmeterol (50 ?g b.i.d.) como comparador activo administrado mediante inhalador DISKUS
    A.4.1Sponsor's protocol code numberCQAB149B2349
    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.3.10 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 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 Information not present in EudraCT
    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 nameSalmeterol admisistered by DISKUS inhlaler
    D.3.4Pharmaceutical form Inhalation powder
    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 INNSalmeterol
    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) 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
    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
    EPOC (Enfermedad Pulmonar Obstructiva Cronica)
    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
    Demostrar la superioridad de indacaterol (150 µg o.d.) frente a salmeterol (50 µg b.i.d.) en cuanto al área bajo la curva (AUC) estandarizada para el volumen espiratorio forzado (FEV1) entre los 5 minutos y 11 h. 45 min. posteriores a las dosis matutinas después de 84 días de tratamiento en pacientes con EPOC de moderada a grave.
    E.2.2Secondary objectives of the trial
    Demostrar la superioridad de indacaterol (150 g o.d) frente a salmeterol (50 µg b.i.d.) en cuanto al FEV1 valle después de 84 días de tratamiento en ambos grupos: Valle se refiere a la media del FEV1 a las 23:10 y 23:45 h. después de la dosis matutina de indacaterol; y la media del FEV1 a las 11:10 y 11:45 h. después del tiempo anticipado de la dosis nocturna de salmeterol.
    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 capaces de participar con un diagnóstico de EPOC (de moderada a grave de acuerdo con las Guías GOLD, 2007, Anexo 2) y que incluyen:
    3. Antecedentes de consumo de tabaco de al menos 10 paquetes/año.
    4. FEV1 postbroncodilatador < 80% y >= 30% del valor teórico normal en la selección (visita 2).
    4. FEV1/FVC postbroncodilatador < 70% en la selección (visita 2).
    (“Post” se refiere a entre 10 y 15 minutos después de la inhalación de 400 µg (4x100 µg) de salbutamol, equivalente a 4 x 90 µg de albuterol administrado a través de la boquilla, en la selección (visita 2)).
    E.4Principal exclusion criteria
    1.Mujeres embarazadas o en periodo de lactancia, donde embarazo se define como el estado de una mujer después de la concepción y hasta la finalización de la gestación, confirmado por un resultado positivo del análisis de gonadotropina coriónica humana en suero (> 5 mUI/mL).
    2.Mujeres potencialmente fértiles, definidas como toda mujer fisiológicamente capaz de quedarse embarazada, incluyendo mujeres cuya profesión, estilo de vida u orientación sexual impida la relación sexual con una pareja masculina y mujeres cuyas parejas hayan sido esterilizadas por vasectomía u otros métodos, A MENOS que cumplan la siguiente definición de postmenopausia: 12 meses de amenorrea natural (espontánea) o 6 meses de amenorrea espontánea con niveles de FSH en suero > 40 mUI/mL o que estén utilizando uno o más de los siguientes métodos anticonceptivos aceptables:
    • Esterilización quirúrgica (p. ej., ligadura de trompas bilateral, histerectomía).
    • Anticonceptivos hormonales (implante, parche, oral).
    • Métodos de doble barrera (cualquier combinación doble de: DIU, preservativo masculino o femenino con gel espermicida, diafragma, esponja, capuchón cervical).
    3. Los métodos anticonceptivos aceptables pueden incluir la abstinencia total según el criterio del investigador en los casos donde la edad, la profesión, el estilo de vida o la orientación sexual del paciente garanticen el cumplimiento. La abstinencia periódica (p. ej., métodos del calendario, de la ovulación, sintotérmicos, de postovulación) y el “coitus interruptus” (conocido como “marcha atrás”) no son métodos anticonceptivos aceptables. Los métodos anticonceptivos fiables deberán mantenerse durante todo el estudio y durante 30 días después de la discontinuación del fármaco del estudio.
    4. Pacientes que hayan tenido que recibir tratamiento con glucocorticoides sistémicos o antibióticos, o que hayan sido hospitalizados en las 6 semanas previas a la selección (visita 2) debido a una exacerbación de la EPOC. El paciente deberá discontinuar el estudio, en caso de que ocurra una exacerbación durante el periodo de inclusión. El paciente puede ser reclutado de nuevo cuando cumpla los criterios de inclusión/exclusión.
    5. Pacientes cuyo índice de masa corporal sea inferior a 15 o superior a 40 kg/m2.
    6. Pacientes que precisen oxigenoterapia para hipoxemia crónica (excluida la exacerbación de la EPOC aguda). Estos pacientes normalmente requieren una oxigenoterapia > 15 horas al día administrada en casa mediante un concentrador o cilindro de oxígeno.
    7. Pacientes que hayan presentado infección del tracto respiratorio durante las 6 semanas previas a la selección (visita 2). Los pacientes que desarrollen una infección del tracto respiratorio entre la preselección (visita 1) y la aleatorización (visita 3) deberán discontinuar el ensayo, pero se puede permitir reclutarlos de nuevo en una fecha posterior, una vez cumplan los criterios de inclusión/exclusión.
    8. Pacientes con enfermedad pulmonar concomitante, tuberculosis pulmonar (a menos que se confirme por radiografía de tórax que ya no es activa) o bronquiectasia clínicamente significativa.
    9. Pacientes con antecedentes de asma indicada por (pero no limitada a):
    • Inicio de síntomas respiratorios que indiquen asma antes de cumplir los 40 años.
    • Antecedentes de diagnóstico de asma.
    10. Pacientes con diabetes Tipo I o diabetes Tipo II no controlada incluyendo 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 selección (visita 2).
    11. Pacientes que, a criterio del investigador o del equipo responsable de Novartis, tengan una anomalía de laboratorio clínicamente relevante o una afección clínicamente significativa como (aunque no limitado a) enfermedad cardiaca isquémica inestable, arritmia (excluyendo fibrilación auricular crónica estable) u otros hallazgos de ECG clínicamente significativos, hipertensión no controlada y otra enfermedad cardiaca significativa o defecto de conducción, hipo e hipertiroidismo no controlados, hipocalcemia, estado hiperadrenérgico o cualquier condición que a criterio del investigador o del equipo responsable de Novartis pueda comprometer la seguridad o el cumplimiento del paciente, interferir con la evaluación, o impedir la finalización del estudio.
    12.Cualquier paciente con cáncer de pulmón o antecedentes de cáncer de pulmón.
    13.Cualquier paciente con cáncer activo o antecedentes de cáncer con menos de 5 años de tiempo de supervivencia libre de enfermedad (independientemente de si hay o no evidencia de recurrencia o metástasis locales). Se acepta carcinoma de células basales localizado (sin metástasis) de piel. Los pacientes con antecedentes de cáncer (exceptuando el cáncer de pulmón) y 5 años o más de tiempo de supervivencia libre de enfermedad solo se pueden incluir en el estudio acordándolo con el equipo de la oficina central de Novartis caso por caso.
    E.5 End points
    E.5.1Primary end point(s)
    Demostrar la superioridad de indacaterol (150 µg o.d.) frente a salmeterol (50 µg b.i.d.) en cuanto al área bajo la curva (AUC) estandarizada para el volumen espiratorio forzado (FEV1) entre los 5 minutos y 11 h. 45 min. posteriores a las dosis matutinas después de 84 días de tratamiento en pacientes con EPOC de moderada a grave.
    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 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 Yes
    E.8.1.6Cross over No
    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 No
    E.8.2.3Other No
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    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
    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 months12
    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 months12
    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 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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 565
    F.4.2.2In the whole clinical trial 1084
    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 Decision2009-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-06
    P. End of Trial
    P.End of Trial StatusCompleted
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