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    Summary
    EudraCT Number:2008-000901-13
    Sponsor's Protocol Code Number:CQMF149B2202
    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:2010-02-17
    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 number2008-000901-13
    A.3Full title of the trial
    Estudio piloto, multicéntrico, aleatorizado, doble ciego, con doble enmascaramiento, de grupos paralelos y de 8 semanas de duración para investigar el efecto del Twisthaler® de QMF (250/400 µg o.d. por la noche) comparado con propionato de fluticasona/salmeterol (250/50 µg bid) en pacientes con Enfermedad Pulmonar Obstructiva Crónica (EPOC)
    A.4.1Sponsor's protocol code numberCQMF149B2202
    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 Farmaceutica 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 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 maleate/mometasone furoate
    D.3.2Product code QMF149
    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 INNIndacaterol maleate
    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 number250
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMometasone furoate
    D.3.9.1CAS number 83919-23-7
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Seretide Inhaler
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    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 INNFluticasone propionate
    D.3.9.1CAS number 80474-14-2
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSalmeterol
    D.3.9.1CAS number 89365-50-4
    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
    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
    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
    El objetivo principal es calcular el efecto broncodilatador de Twisthaler® de QMF 250//400 µg q.d.frente al MDDPI de propionato de fluticasona/salmeterol 250/50 µg b.i.d. a lo largo de 24 horas en sujetos con EPOC de moderada a grave en un rango de criterios de valoración y escoger los criterios de valoración clínicamente significativos para un posible uso en un estudio pivotal de Fase III de registro.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Hombres y mujeres adultos de edad  40 años, que hayan firmado un formulario de consentimiento informado antes de iniciar cualquier procedimiento relacionado con el estudio, incluido cualquier ajuste de la medicación para la EPOC antes de la visita 1.
    2.Pacientes con un diagnóstico de EPOC de moderada a grave de acuerdo con las Guías GOLD (2006) y que cumplan asimismo los siguientes criterios:
    a)Ex fumador o fumador activo con una historia de tabaquismo de al menos 10 paquetes/año.
    NOTA: Los fumadores activos deberán proporcionar una notificación verbal o un documento por escrito que atestigüe su incapacidad para dejar de fumar después de su participación (o negación a participar) en un programa para dejar de fumar. Los ex fumadores se definen como aquellos que han dejado de fumar al menos 12 meses antes de la visita 1.
    b) FEV1 postbroncodilatador en la visita 1 entre el 30 y el 65% del valor teórico normal [Quanjer et al. 1994]. Este criterio para el FEV1 deberá demostrarse después de las pruebas de reversibilidad tras un periodo de lavado de al menos 6 horas durante el cual no se haya inhalado ningún agonista 2 de corta duración, 8 horas para el anticolinérgico de corta duración o CDF de anticolinérgico inhalado/SABA y 48 horas para los CI, agonistas 2 de larga duración o CDF de CI/ agonista 2.
    c) FEV1/FVC postbroncodilatador < 70%
    d) CPT o CRF del 120% del valor teórico normal en aquellos pacientes a los que se les realicen las evaluaciones de pletismografía corporal.
    (Postbroncodilatador se refiere a las determinaciones de aproximadamente 30 minutos después de la inhalación de 4 inhalaciones de 100/90 µg de salbutamol/albuterol en un MDI o la dosis equivalente de DPI)
    3.Los pacientes deberán tomar únicamente agonistas 2 de corta duración durante al menos 7 días antes de la aleatorización (visita 2).
    E.4Principal exclusion criteria
    • Mujeres embarazadas, en periodo de lactancia o físicamente fértiles, independientemente de si son o no sexualmente activas, si no utilizan un método anticonceptivo fiable.
    • Pacientes que hayan presentado una exacerbación de la EPOC durante las 4 semanas anteriores a la aleatorización y que precise intervención médica o tratamiento adicional con medicación excluida.
    • Pacientes que muestren un aumento en el FEV1 ≥ 400 mL durante los 30 minutos posteriores a la administración de cuatro inhalaciones de 100/90 µg de salbutamol/albuterol en la visita de selección.
    • Pacientes que precisen oxigenoterapia (> 15 horas al día) para hipoxemia crónica (se acepta el uso prn hasta en un total de 10 horas en cualquier periodo de 24 horas).
    • Pacientes que hayan presentado infección aguda del tracto respiratorio durante las 4 semanas previas a la visita 1. Los pacientes que desarrollen una infección del tracto respiratorio entre la visita 1 y la visita 2 deberán discontinuar el ensayo, pero se puede permitir incluirlos de nuevo en una fecha posterior (al menos 4 semanas después de la resolución de la infección del tracto respiratorio).
    (Remítase al apartado 5.2 para un listado completo de los criterios de exclusión)
    E.5 End points
    E.5.1Primary end point(s)
    Para evaluar el efecto broncodilatador junto con otros efectos de Twisthaler® de QMF (250/400 µg q.d.) vs. MDDPI de propionato de fluticasona/salmeterol (250/50 µg bid) se medirán las siguientes variables:
    •FEV1 y FVC a los -20 minutos antes de la administración del fármaco.
    •FEV1 y FVC a los 5 y 30 minutos, 1, 2, 3, 4 horas postdosis (días 1, 27, 54) y 10, 11, 12 h. 15 min., 14, 16, 18, 20, 22, 23 h. 45 min. postdosis (días 2, 28, 55).
    •FEV1 pico (FVC) y tiempo para alcanzar el FEV1 pico (FVC).
    •Inicio de la acción (momento en el que hay una mejora del 12% en el FEV1 medio respecto al basal).
    •Duración de la acción (período de tiempo en el que hay una mejora del 12% en el FEV1 medio respecto al basal).
    •Área bajo la curva estandarizada del FEV1 (FVC) de 0-24 horas.
    •Capacidad inspiratoria (CI) y capacidad residual funcional (CRF) medidas mediante pletismografía corporal realizada40 minutos antes de la administración del fármaco (días 1, 27, 54) y a las 11 h. 40 min. y 23 h. 40 min. después de la administración del fármaco (días 2, 28, 55).
    •FEV1 predosis diario (FVC) (a.m. y p.m. predosis) mediante un espirómetro portátil /diario electrónico entre las visitas del estudio.
    •Síntomas de la EPOC durante el día y durante la noche que incluyen: sibilancia, tos y dificultad al respirar.
    •Uso de medicación de rescate.
    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 No
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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 state10
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 70
    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 Decision2008-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-01-11
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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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