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    Summary
    EudraCT Number:2006-006796-21
    Sponsor's Protocol Code Number:D5892C00015
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-04-11
    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 number2006-006796-21
    A.3Full title of the trial
    Ensayo de 12 semanas doble ciego, aleatorizado, de grupos paralelos y multicéntrico para evaluar la eficacia y la seguridad de budesonida/formoterol (Symbicort® Turbuhaler®) 320/9 µg, una inhalación dos veces al día, además de tiotropio (Spiriva®) 18 µg, una inhalación una vez al día, en comparación con tiotropio 18 μg, una inhalación una vez al día, en pacientes con enfermedad pulmonar obstructiva crónica (EPOC) grave
    A.3.2Name or abbreviated title of the trial where available
    CLIMB
    A.4.1Sponsor's protocol code numberD5892C00015
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 Yes
    D.2.1.1.1Trade name Symbicort Turbuhaler 320/9 microgram/inhalation
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 INNBudesonida
    D.3.9.1CAS number 51333223
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number320
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNformoterol fumarato
    D.3.9.1CAS number 43229807
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim
    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.3.9.1CAS number 411207313
    D.3.9.3Other descriptive namebromuro de tiotropio
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22.5
    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: 3
    D.1.2 and D.1.3IMP Role
    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 Bricanyl Turbuhaler
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 INNSulfato de terbutalina
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    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) grave
    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 de este ensayo es evaluar la eficacia en la función pulmonar de Spiriva®, 18 μg una inhalación una vez al día + Symbicort® Turbuhaler® 320/9 μg una inhalación dos veces al día, en comparación con Spiriva 18 μg una inhalación una vez al día en monoterapia.
    E.2.2Secondary objectives of the trial
    El objetivo secundario del ensayo es evaluar la seguridad valorando la naturaleza, la incidencia y la intensidad de los AA y las constantes vitales en los grupos de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Entrega del consentimiento informado antes de realizar cualquier procedimiento relacionado con el ensayo.
    2. Pacientes ambulatorios de ambos sexos, de edad ³40 años
    3. Diagnóstico clínico de EPOC y síntomas desde hace más de 2 años
    4. Fumador o ex fumador, con antecedentes de tabaquismo equivalentes a 10 o más paquetes-años (1 paquetes-año = 20 cigarrillos al día durante un año)
    5. Antecedentes de una exacerbación de la EPOC como mínimo, que precisara una dosis de esteroides orales o de antibióticos, entre 1 y 12 meses antes de la visita 2
    6. FEV1 ≤50% del valor normal previsto, medido antes de administrar el broncodilatador
    7. FEV1/VC <70%, antes de administrar el broncodilatador
    8. Pacientes que sepan leer y escribir y utilizar los dispositivos electrónicos (diario-e y medidor de flujo máximo)
    Para ser aleatorizados al período de tratamiento, deberán cumplirse los criterios siguientes en la visita 3:
    9. Puntuación total de síntomas de la EPOC ≥2 al día durante al menos 7 días del período de preinclusión (suma de la puntuación de los apartados del diario: respiración, tos y opresión torácica) o durante al menos la mitad del período de preinclusión si duró más de 14 días
    10. Registros matutinos de los datos de PEF y GCSQ al menos 7 de los últimos 10 días del período de preinclusión
    E.4Principal exclusion criteria
    1. Empeoramiento de la EPOC durante la preinclusión o en las 4 semanas anteriores a la visita 2, que precise hospitalización, un ciclo de esteroides orales o inhalados, antibióticos o ambos
    2. Uso de glucocorticosteroides inhalados en las 2 semanas anteriores a la visita 2
    3. Uso de glucocorticosteroides orales/parenterales en las 4 semanas anteriores a la visita 2
    4. Cualquier hallazgo anómalo de importancia clínica en la exploración física o las constantes vitales que, en opinión del investigador, pueda suponer un riesgo para el paciente a causa de su participación en el ensayo.
    5. Antecedentes de asma
    6. Antecedentes de rinitis alérgica estacional antes de los 40 años de edad
    7. Cardiopatía isquémica importante o inestable, arritmia, miocardiopatía, insuficiencia cardíaca, insuficiencia renal, hipertensión no controlada en opinión del investigador o cualquier otro trastorno cardiovascular importante en opinión del investigador
    8. Oxigenoterapia regular
    9. Cualquier trastorno respiratorio activo distinto de la EPOC, que el investigador considere de importancia clínica
    10. Cualquier enfermedad o trastorno importante que, en opinión del investigador, pueda poner al paciente en riesgo debido a su participación en el ensayo o influir en los resultados del ensayo o en la capacidad del paciente para participar en el mismo.
    11. Pacientes con glaucoma de ángulo estrecho de importancia clínica, hiperplasia prostática importante u obstrucción del cuello de la vejiga en quienes el tratamiento con tiotropio pueda suponer un empeoramiento de los signos y síntomas relacionados con estas afecciones, a juicio del investigador
    12. Pacientes en tratamiento con betabloqueantes no cardioselectivos
    13. Embarazo, lactancia materna o embarazo previsto durante el ensayo. Mujeres fértiles que no utilicen medidas anticonceptivas aceptables, a juicio del investigador.
    14. Hipersensibilidad presunta o confirmada al tratamiento del ensayo o a sus excipientes, incluida la atropina o sus derivados, y al ipatropio y sus componentes, a juicio del investigador
    15. Hospitalización prevista del paciente durante el ensayo
    16. Pacientes que hayan participado en un ensayo clínico para evaluar un fármaco en investigación en las 4 semanas anteriores al reclutamiento o a quienes se haya asignado previamente un código de aleatorización en este ensayo
    17. Pacientes con antecedentes de alcoholismo o toxicomanía crónicos o con cualquier afección que se asocie a un cumplimiento insuficiente
    18. Pacientes que estén participando o estén citados para participar en un programa intensivo de rehabilitación de la EPOC
    19. Previsión de donar sangre durante el ensayo
    20. Participación en la planificación y realización del ensayo (se aplica al personal tanto de AstraZeneca como del centro de ensayo)
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de valoración será la variación del FEV1 antes de la dosis entre el valor de la visita 3 y la media de los valores obtenidos entre las visitas 4 y 6. Esta variable se utilizó como base para el cálculo del tamaño de la muestra
    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 Yes
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    El final del ensayo se define como la fecha de cierre de la base de datos, que es el momento a partir del cual ningún paciente estará expuesto a actividades relacionadas con el ensayo.
    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 months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 485
    F.4.2.2In the whole clinical trial 620
    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 Decision2007-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-14
    P. End of Trial
    P.End of Trial StatusOngoing
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