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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-005468-28
    Sponsor's Protocol Code Number:CQAB149B2340
    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:2010-03-08
    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 number2007-005468-28
    A.3Full title of the trial
    Estudio fase III, multicéntrico, aleatorizado, cruzado, doble ciego, controlado con placebo, de 3 periodos y 14 días de duración, para determinar el perfil de función pulmonar durante 24 horas de indacaterol (300 µg o.d.) en pacientes con EPOC de moderada a grave, usando salmeterol abierto (50 µg b.i.d.) como control activo.
    A.4.1Sponsor's protocol code numberCQAB149B2340
    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.3.9.2Current 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: 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 Serevent Diskus
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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
    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
    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
    Demostrar la superioridad de indacaterol (300 µg o.d.) sobre placebo en cuanto al FEV1 valle de 24 horas en el día 14 de tratamiento. El FEV1 valle de 24 horas se define como la media de las determinaciones del FEV1 a las 23 horas 10 min. y 23 horas 45 min. postdosis.
    E.2.2Secondary objectives of the trial
    Demostrar la superioridad de indacaterol sobre placebo en cuanto al FEV1 de periodo de tiempo individual en los días 1 y 14 del tratamiento.
    Evaluar las áreas bajo las curvas en función del tiempo (AUC) del FEV1 de 0-24 horas y de 0-12 horas de indacaterol frente a placebo en los días 1 y 14 del tratamiento.
    Comparar los efectos de indacaterol frente a placebo en cuanto al FEV1 valle de 24 horas después de un único día de tratamiento.
    Evaluar los efectos de indacaterol frente a placebo en cuanto al efecto pico y al tiempo para alcanzar el nivel del efecto pico determinado por el FEV1 en el primer día de tratamiento.
    Evaluar la seguridad de indacaterol en cuanto a las constantes vitales, glucosa y potasio, electrocardiograma (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 Iniciativa Global para Enfermedad Pulmonar Obstructiva Crónica (GOLD), 2006; véase el Anexo 6) y:
    a) Antecedentes de consumo de tabaco de al menos 20 paquetes año.
    b) FEV1 post-broncodilatador < 80% y ≥ 30% del valor teórico normal.
    c) FEV1/FVC (Capacidad vital forzada) post-broncodilatador < 70%.
    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 2 o durante el periodo de inclusión.
    4. Pacientes que precisen oxigenoterapia de larga duración
    5. Pacientes que hayan presentado infección del tracto respiratorio durante las 6 semanas previas a la visita 2.
    6. Pacientes con enfermedad pulmonar concomitante,
    7. Pacientes con una historia (hasta e incluyendo la visita 2) de asma
    8. Pacientes con diabetes Tipo I o diabetes Tipo II no controlada
    9. Pacientes que, a criterio del investigador o del equipo responsable de Novartis, tengan una anomalía de laboratorio clínicamente relevante o una afección clínicamente significativa
    10. Cualquier paciente con cáncer de pulmón o antecedentes de cáncer de pulmón.
    11. Cualquier paciente con cáncer activo o antecedentes de cáncer con menos de 5 años de tiempo de supervivencia libre de enfermedad
    12. Pacientes con antecedentes de síndrome QT largo, o cuyo intervalo QTc (fórmula de Bazett) medido en la visita 2 o en la visita 3 esté prolongado: > 450 ms (hombres) o > 470 ms (mujeres)
    13. Pacientes con antecedentes de hipersensibilidad a alguno de los fármacos del estudio o a fármacos con estructuras químicas similares
    14. Pacientes que no mantengan ciclos regulares día/noche,
    15. 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 2, cualquiera que sea el periodo más largo.
    16. Pacientes que hayan recibido vacunas vivas atenuadas durante los 30 días previos a la visita 2 o durante el periodo de inclusión
    17. Tratamientos para la EPOC y afecciones relacionadas: las siguientes medicaciones no deberán ser utilizadas antes de la visita 2, durante al menos el periodo de lavado mínimo que se especifica a continuación o en cualquier momento durante el estudio:a)El anticolinérgico de larga duración tiotropio: 7 días.b) anticolinérgicos de corta duración: 8 horas.c)Combinaciones fijas de agonistas b2 y corticosteroides inhalados: 48 horas.d) Combinaciones fijas de anticolinérgicos y agonistas b2 de corta duración: 8 horas. e)Agonistas b2 de larga duración: 48 horas.
    f) Agonistas b2 de corta duración:6 horas. g)Teofilina y otras xantinas: 1 semana. h) Corticosteroides parenterales u orales: 1 mes.
    18. 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 2.b) Antihistamínicos (excluyendo los que aparecen en el punto 19c) – al menos 5 días antes de la visita 2.
    19. 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)Antiarrítmicos cardiacos de Clase Ia (p. ej., disopiramida, procainamida, quinidina) y 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 2; los pacientes presentan un ECG normal en la visita 2 y no hay evidencia clínica de anomalías previas del ECG).
    e)Cromoglicato, nedocromilo, ketotifeno y antagonistas del leucotrieno.
    20. Pacientes incapaces de utilizar de forma adecuada un dispositivo inhalador de polvo seco, o de realizar las determinaciones de la espirometría.
    21. Pacientes con antecedentes conocidos de no-cumplimiento con la medicación
    E.5 End points
    E.5.1Primary end point(s)
    Demostrar la superioridad de indacaterol (300 µg o.d.) sobre placebo en cuanto al FEV1 valle de 24 horas en el día 14 de tratamiento. El FEV1 valle de 24 horas se define como la media de las determinaciones del FEV1 a las 23 horas 10 min. y 23 horas 45 min. postdosis
    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 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 Yes
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    The trial will be complete when the last patient completes Visit 8
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    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) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 54
    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)
    Tratamiento esperado para su condición
    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 Decision2008-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-07-31
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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