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    Summary
    EudraCT Number:2010-022721-14
    Sponsor's Protocol Code Number:QVA149A2305
    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:2010-11-26
    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 number2010-022721-14
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, ciego, doble simulación, con control placebo, tres periodos, cruzado, para evaluar el efecto del QVA149 (110/50 µg o.d.) en la resistencia al ejercicio en pacientes con enfermedad pulmonar obstructiva crónica (EPOC) moderada a severa, utilizando tiotropio como control activo.
    A.4.1Sponsor's protocol code numberQVA149A2305
    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/Glycopyrronium bromide
    D.3.2Product code QVA149
    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 INNGLYCOPYRRONIUM BROMIDE
    D.3.9.1CAS number 596510
    D.3.9.3Other descriptive nameGlycopyrrolate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINDACATEROL
    D.3.9.1CAS number 312753-06-3
    D.3.9.3Other descriptive nameIndacaterol Maleate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number110
    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 SPIRIVA® administrado mediante Handihaler
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim Pharma 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, administrado mediante Handihaler®
    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 INNTiotropium Bromide
    D.3.9.1CAS number 139404481
    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 Crónica (EPOC)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    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 el efecto del QVA149 110/50 µg comparado con placebo de QVA149 inhalado una vez al día sobre la tolerancia al ejercicio medido como el tiempo de resistencia al ejercicio durante una ergometría de ciclo de carga constante submáxima (SMETT) después de tres semanas de tratamiento.
    E.2.2Secondary objectives of the trial
    -Determinar el efecto de QVA149 110/50 µg una vez al día en comparación con placebo sobre la capacidad inspiratoria en isotiempo durante la SMETT después de tres semanas de tratamiento.
    -Determinar el efecto de QVA149 110/50 µg una vez al día comparado con placebo sobre la capacidad inspiratoria mínima (IC) (es decir, 24 h después de la dosis) después de tres semanas de tratamiento.
    -Determinar el efecto de QVA149 110/50 µg una vez al día comparado con placebo sobre la FEV1 en concentración mínima (es decir, 24 h después de la dosis) después de tres semanas de tratamiento.
    -Determinar el efecto de QVA149 110/50 µg una vez al día comparado con placebo en las pruebas funcionales pulmonares el día 1 y el día 21 a los 5 minutos y a los 15 minutos tras la dosis determinada por pletismografía corporal.
    -Evaluar los efectos de QVA149 110/50 µg una vez al día en comparación con placebo en la espirometría después de tres semanas de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Hombres o mujeres adultos de edad 40 años (en la visita 1), que hayan firmado un Documento de Consentimiento Informado antes del inicio de cualquier procedimiento relacionado con el estudio.
    2.Pacientes con EPOC estable moderada a grave (Estadio II o Estadio III) según las Guías GOLD de 2009
    3.Fumadores o ex fumadores con antecedentes de consumo de tabaco de al menos 10 paquetes-años. (Diez paquetes-años se define como 20 cigarrillos al día durante 10 años o 10 cigarrillos al día durante 20 años, etc.)
    4.Pacientes con un FEV1 postbroncodilatador* 40% y <70% del valor normal predicho y FEV1/FVC postbroncodilatador < 0,7 en la visita 2.
    *["Post" hace referencia a una hora después de la inhalación secuencial del equivalente de 84 µg (desde la válvula) o 17 µg (desde la boquilla) de bromuro de ipratropio y 400 µg (desde la válvula) de base de salbutamol)]
    E.4Principal exclusion criteria
    1.Mujeres embarazadas o en período de lactancia (embarazo confirmado mediante prueba de embarazo en orina positiva).
    2.Mujeres en edad fértil (WOCBP), definidas como toda mujer fisiológicamente capaz de quedarse embarazada, incluyendo mujeres cuya carrera, estilo de vida u orientación sexual impida la relación sexual con una pareja masculina y mujeres cuyas parejas hayan sido esterilizadas mediante vasectomía u otros métodos, A MENOS que cumplan la siguiente definición de post-menopausia: 12 meses de amenorrea natural (espontánea), O 6 que hayan pasado seis semanas desde ooforectomía quirúrgica bilateral (con o sin histerectomia), O que estén utilizando uno o más de los métodos anticonceptivos aceptables siguientes (NOTA: El método anticonceptivo fiable debe mantenerse durante todo el estudio)
    -esterilización quirúrgica (por ejemplo, ligadura de trompas bilateral),
    -método de doble barrera (si lo aceptan las autoridades sanitarias locales y el comité ético)
    -anticonceptivos hormonales (implante, parche, oral, intramuscular), y DIU recubierto de cobre (si fuese aceptado por las autoridades sanitarias locales y el comité ético).
    -a criterio del investigador, la abstinencia total es aceptable en casos en que la edad, la carrera profesional, el estilo de vida, o la orientación sexual del paciente garantice el cumplimiento.
    -La abstinencia periódica (por ejemplo, métodos del calendario, ovulación, medición de la temperatura, post-ovulación) y la marcha atrás no son métodos anticonceptivos aceptables.
    3.Pacientes con contraindicaciones al tratamiento con, o que tengan antecedentes de reacciones/hipersensibilidad a cualquiera de los siguientes fármacos inhalados o fármacos de una clase similar o cualquier otro componente:
    agentes anticolinérgicos
    beta-2 agonistas de acción prolongada y corta
    aminas simpaticomiméticas.
    lactosa o cualquiera de los otros excipientes
    4.Pacientes con antecedentes de síndrome QT largo o cuyo intervalo QTc determinado en la selección (método de Fridericia) esté prolongado (> 450 ms para hombres y mujeres) según confirmación del asesor de ECG central
    5.Pacientes que tengan una anomalía clínicamente significativa en el ECG en la selección que a criterio del investigador pueda constituir un posible riesgo si se incluye en el estudio. (Estos pacientes no deben ser seleccionados nuevamente).
    6.Pacientes con diabetes Tipo I o Tipo II no controlada.
    7.Pacientes que no han obtenido un resultado aceptable en la espirometría de la visita 2 de conformidad con los criterios ATS/ERS para la aceptabilidad y la repetibilidad.
    8.Pacientes con un valor Wmax < 20 W (determinado por la prueba de resistencia de ciclo gradual en la visita 2).
    9.Pacientes cuyo índice de masa corporal sea inferior a 15 o superior a 40 kgm2
    10.Pacientes con contraindicaciones a las pruebas de esfuerzo cardiopulmonar, incluido (de manera enunciativa y sin limitarse a):
    Infarto agudo de miocardio (6 meses)
    Angina inestable
    Arritmias no controladas que provocan síntomas o alteración hemodinámica
    Endocarditis activa
    Miocarditis o pericarditis aguda
    Estenosis aórtica sintomática
    Insuficiencia cardíaca no controlada
    Embolia pulmonar agudo o infarto pulmonar
    Trastorno no cardiaco agudo que puede afectar a la realización de ejercicio o agravarse con el ejercicio (por ejemplo, infección, insuficiencia renal, tirotoxicosis)
    Estenosis coronaria principal izquierda o equivalente
    Enfermedad cardiaca valvular esténotica moderada
    Alteraciones electrolíticas
    Hipertensión arterial grave no tratada (>200 mm Hg sistólica, > 120 mm Hg diastólica)
    Hipertensión pulmonar importante
    Taquiarritmias o bradiarritmias
    Cardiomiopatía hipertrófica
    Discapacidad mental que supone incapacidad para cooperar
    Bloqueo atrioventricular de alto grado
    Trombosis en las extremidades inferiores
    11.Pacientes con saturación de oxígeno (5 mín) en reposo en el aire ambiente de <85%
    12.Pacientes que no mantienen ciclos de vigilia/sueño regulares día/noche (por ejemplo, trabajadores a turnos nocturnos).
    13.Pacientes cuya resistencia en la prueba de esfuerzo esté limitada por afecciones no respiratorias como por ejemplo, trastornos neurológicos, ortopédicos u otros.
    14.Pacientes con glaucoma de ángulo estrecho, hiperplasia prostática sintomática u obstrucción del cuello de la vejiga o alteración renal moderada a grave o retención urinaria. (Los pacientes con resección transuretral de próstata (TURP) se excluyen del estudio. Los pacientes a quienes se les haya realizado una resección total de próstata se pueden considerar para el estudio, así como los pacientes que están asintomáticos y estables con tratamiento farmacológico para dicha alteración)
    E.5 End points
    E.5.1Primary end point(s)
    Eficacia del QVA149 110/50 µg comparado con placebo inhalado una vez al día sobre la tolerancia al ejercicio medido como el tiempo de resistencia al ejercicio durante una ergometría de ciclo de carga constante submáxima (SMETT) después de tres semanas 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 No
    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.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Definido en el protocolo
    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 months11
    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 months11
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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 Decision2011-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-30
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