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    The EU Clinical Trials Register currently displays   43858   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:2008-007944-33
    Sponsor's Protocol Code Number:CQAB149B2348
    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:2009-01-28
    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 number2008-007944-33
    A.3Full title of the trial
    Estudio de Fase IIIb, multicéntrico, de 52 semanas de duración, aleatorizado, ciego, doble enmascarado, de grupos paralelos y de eficacia que compara el efecto de indacaterol 150 µg o.d. inhalado frente a tiotropio 18 µg o.d. inhalado en la función pulmonar, la tasa de exacerbaciones y resultados relacionados en pacientes con EPOC.
    A.3.2Name or abbreviated title of the trial where available
    INVIGORATE
    A.4.1Sponsor's protocol code numberCQAB149B2348
    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 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 Spiriva 18 microgram inhalation powder, hard capsule
    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.3.4Pharmaceutical 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 INNTIOTROPIO BROMURO
    D.3.9.3Other descriptive nameTIOTROPIUM BROMIDE
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Enfermedad Pulmonar Obstructiva Cronica (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 150 µg o.d frente a tiotropio 18 µg o.d en cuanto al FEV1 (valle) de 24 horas postdosis después de 12 semanas de tratamiento. La medida 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 matutina.
    E.2.2Secondary objectives of the trial
    Demostrar la no inferioridad de indacaterol 150 µg o.d frente a tiotropio 18 µg o.d. en cuanto a la tasa de exacerbaciones durante 52 semanas de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hombres y mujeres adultos de edad > o = 40 años que hayan firmado el formulario de consentimiento informado antes de iniciar cualquier procedimiento relacionado con el estudio.
    2. Pacientes con un diagnóstico de EPOC a los 40 años o mayores.
    3. Pacientes ambulatorios capaces de participar con un diagnóstico de EPOC grave (grave según la Guías GOLD, 2007 (Anexo 7) y que incluyen:
    a) Antecedentes de consumo de tabaco de al menos 10 paquetes/año, pueden ser elegidos tanto los fumadores como los ex fumadores.
    b) FEV1 postbroncodilatador <50% y &#8805;30% del valor teórico normal.
    c) FEV1/FVC postbroncodilatador <70%.
    d) Una historia documentada de al menos 1 exacerbación moderada o grave durante los 12 meses previos (donde exacerbación se define como un empeoramiento de 2 o más de los siguientes síntomas principales durante al menos 2 días consecutivos):
    • disnea;
    • volumen de esputo;
    • purulencia de esputo.
    Y que precisen tratamiento con corticoides sistémicos o antibiótico.
    O
    empeoramiento de uno de los síntomas principales junto con uno de los siguientes síntomas menores durante al menos 2 días consecutivos:
    • dolor de garganta;
    • resfriados (rinorrea y/o congestión nasal);
    • fiebre sin otras causas;
    • incremento de la tos;
    • incremento de sibilancias.
    Y que precisen tratamiento con corticoides o antibióticos.
    Las exacerbaciones de la EPOC se consideran de intensidad moderada si requirieron tratamiento con corticoides sistémicos o antibióticos y se consideran de intensidad grave si también precisaron la hospitalización. Una visita a urgencias de más de 24 horas se considerará como una hospitalización.
    (Post se refiere a entre 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 visita 2).
    E.4Principal exclusion criteria
    1. Pacientes que hayan tenido que recibir tratamiento con glucocorticoides sistémicos o antibióticos en las 6 semanas previas a la selección debido a una exacerbación de la EPOC.
    2. Pacientes que necesiten oxigenoterapia para hipoxemia crónica (> 15 horas al día).
    3. Pacientes que hayan presentado infección del tracto respiratorio durante las 6 semanas previas a la selección.
    4. Pacientes con enfermedad pulmonar concomitante
    5. Pacientes con antecedentes de asma
    6. Pacientes con diabetes Tipo I o diabetes Tipo II no controlada.
    7. Cualquier paciente con cáncer de pulmón o antecedentes de cáncer de pulmón.
    8. Cualquier paciente con cáncer activo o antecedentes de cáncer con menos de 5 años de tiempo de supervivencia libre de enfermedad.
    9. Pacientes con antecedentes (o antecedentes familiares) de síndrome de QT largo, o cuyo intervalo QTc (Fredericia) medido en la visita de selección esté prolongado.
    10. Pacientes que hayan recibido vacunas vivas atenuadas durante los 30 días previos a la selección o durante el periodo de inclusión.
    11. Pacientes incapaces de utilizar de forma adecuada un dispositivo inhalador de polvo seco o de realizar las determinaciones de la espirometría.
    E.5 End points
    E.5.1Primary end point(s)
    Demostrar la superioridad de indacaterol 150 µg o.d frente a tiotropio 18 µg o.d en cuanto al FEV1 (valle) de 24 horas postdosis después de 12 semanas de tratamiento. La medida 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 matutina.
    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
    Doble Enmascarado
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA222
    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 Yes
    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 years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 885
    F.4.2.2In the whole clinical trial 3500
    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 Decision2009-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-07-05
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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