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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:2009-014410-10
    Sponsor's Protocol Code Number:CCD-0910-PR-0021
    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:2011-03-03
    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 number2009-014410-10
    A.3Full title of the trial
    Estudio de 12 semanas de duración, multicéntrico, multinacional, aleatorizado, doble ciego, doble enmascadado, de 2 grupos paralelos para comparar la eficacia y seguridad de Foster® 100/6 (dipropionato de beclometasona 100 µg más formoterol 6 µg /dosis), 2 inhalaciones b.i.d, frente a Seretide® 500/50 (fluticasona 500 µg más salmeterol 50 µg /dosis), 1 inhalación b.i.d, en pacientes con Enfermedad Pulmonar Obstructiva Crónica.
    A.4.1Sponsor's protocol code numberCCD-0910-PR-0021
    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 SponsorChiesi Farmaceutici SpA
    B.1.3.4CountryItaly
    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 Foster 100/6mcg
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Farmaceutici SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameFoster 100/6 mcg
    D.3.4Pharmaceutical form Pressurised inhalation, solution
    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 INNBeclomethasone Dipropionate
    D.3.9.1CAS number 5534-09-8
    D.3.9.3Other descriptive nameBDP
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFormoterol Fumarate
    D.3.9.1CAS number 43229-80-7
    D.3.9.3Other descriptive nameFF
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 500 accuhaler
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Wellcome UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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, pre-dispensed
    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 Proprionate
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive nameFP
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSalmeterol Xinafoate
    D.3.9.1CAS number 94749-08-3
    D.3.9.3Other descriptive nameSX
    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 placeboPressurised inhalation, solution
    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, pre-dispensed
    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
    EPOC (Enfermedad Pulmonar Obstructiva Crónica)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Para demostrar la superioridad de Foster ® 100 / 6 (dos inhalaciones) frente a Seretide ® 500 / 50 (una inhalación), en términos de función pulmonar (AUC 0-30min normalizado por el tiempo de cambio desde la pre-dosis en el FEV1) después del fármaco. La inhalación de la mañana del día 1, y la equivalencia entre Foster ® 100 / 6 (dos inhalaciones) y Seretide ® 500/50 (una inhalación) en términos de puntuación del Indice de Transición de Disnea (TDI) en el día 84 en pacientes con enfermedad Enfermedad pulmonar obstructiva.
    E.2.2Secondary objectives of the trial
    Para evaluar la eficacia de los tratamientos de prueba en términos de nuevos parámetros espirométricos y de las medidas de resultado clínico, para evaluar la seguridad y la tolerabilidad, y realizar un análisis exploratorio de la evaluación del consumo de recursos derivados de la gestión de la EPOC en la perspectiva del sistema sanitario.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hombres o mujeres 40 años, que hayan firmado el Formulario de Consentimiento Informado antes de la iniciación de cualquier procedimiento relacionado con el estudio o en su caso obtener el consentimiento informado por el representante legal por escrito .
    2. Pacientes de tratamiento ambulatorio con un diagnóstico clínico de EPOC moderada a grave y que incluirá:
    a) Historia como fumador de al menos 10 paquetes año definido como [(número de cigarrillos fumados por día) (número de años de fumador)] / 20, son elegibles fumadores actuales y exfumadores.
    b) El uso regular de broncodilatadores (por ejemplo, &#946;2-agonistas, anticolinérgicos) en los 2 meses antes de la visita 1.
    c) post-broncodilatador FEV1 <60% del valor normal previsto en la visita 1.
    d) Post-broncodilatador FEV1/CVF <0,7 en la visita 1.
    e) Un aumento en el FEV1 5% del valor basal tras la administración de 400 µg de salbutamol en la visita 1.
    f) Puntuación coordinada en el Indice de Disnea Basal (BDI) 10 (en la visita 1 y en la visita 2).
    3. Historia de no más de una exacerbación de la EPOC en los últimos 12 meses (sin tener en cuenta los últimos 2 meses) a visita 1.
    Una exacerbación de la EPOC se define de acuerdo a lo siguiente: "Un empeoramiento sostenido de la condición del paciente (disnea, tos y /o producción de esputo / purulencia), desde el estado estable y más allá de las variaciones normales del día a día, que es de inicio agudo y exige un cambio en la medicación habitual en un paciente con EPOC subyacente que incluye prescripción de corticosteroides sistémicos (por lo menos 3 días) y / o antibióticos (por lo menos 5 días), o la necesidad de una visita a un servicio de urgencias u hospitalización".
    4. Actitud de cooperación y capacidad para ser entrenados en el uso adecuado de pIDM y DPI (Accuhaler ®, inhalador circular de plástico moldeado) inhaladores.
    E.4Principal exclusion criteria
    1. Diagnostico de asma u otras enfermedades respiratorias (que no sean EPOC) que de acuerdo a la opinión del investigador puedan interferir con la interpretación de los datos.
    2. Embarazadas o mujeres lactantes. Las mujeres en edad fértil sin contracepción eficaz A MENOS que cumplan la siguiente definición de post-menopausia: 12 meses de amenorrea natural (espontánea) o estar utilizando uno o más de los siguientes métodos anticonceptivos aceptables:
    a) esterilización quirúrgica (por ejemplo, la ligadura bilateral de trompas, histerectomía);
    b) anticonceptivos hormonales (implantables, parches, oral. inyectables);
    c) métodos anticonceptivos de barrera: preservativos o capuchón oclusivo (diafragma o cervical / tapas de bóveda) con espuma espermicida / gel / crema / supositorio.
    d) abstinencia continuada (por ejemplo, las monjas).

    La abstinencia periódica (por ejemplo, calendario, ovulación, método sintotérmico, post-ovulación) y la retirada no son métodos anticonceptivos aceptables. Los anticonceptivos fiables se deben mantener durante todo el estudio y durante 30 días después de la interrupción del fármaco del estudio.
    3. Enfermedad inestable, clinica o funcional, simultánea: por ejemplo, hipertiroidismo, diabetes mellitus u otra enfermedad endocrina; insuficiencia hepática significativa, insuficiencia renal significativa, enfermedad cardiovascular (por ejemplo, enfermedad de las arterias coronarias, hipertensión, insuficiencia cardiaca), enfermedades gastrointestinales (por ejemplo, úlcera péptica activa), enfermedad neurológica, enfermedad hematológica, trastornos autoinmunes, o otros que pueden afectar la evaluación de los resultados del estudio según el juicio del investigador.
    4. Patiente con glaucoma de ángulo estrecho.
    5. Anormalidades de laboratorio clínicamente importantes y alteraciones del ECG que indiquen una enfermedad concomitante significativa o inestable que pueda afectar la evaluación de los resultados del estudio y la seguridad del paciente según el juicio del investigador.
    6. Patientes con exacerbación de la EPOC (véase el criterio de inclusión la anterior nº 3) en los 2 meses anteriores a la selección y durante el período de estudio.
    7. Patientes que requieren la terapia de oxígeno a largo plazo (> 12 horas al día) por hipoxemia crónica.
    8. Pacientes tratados con corticoides de depósito en los 2 meses anteriores a la visita 1 y durante el periodo de selección/run-in .
    9. Pacientes con alergia, sensibilidad o intolerancia conocida a los medicamentos simpaticomiméticos o corticoides inhalados o para cualquiera de los excipientes contenidos en los fármacos del estudio.
    10. Pacientes que tienen evidencia de abuso de alcohol o drogas, no cumplidores con el protocolo del estudio o no cumplidores con los tratamientos del estudio según el juicio del investigador.
    11. Cirugía mayor en los 3 meses previos y durante el ensayo que puedan afectar el cumplimiento del paciente en los procedimientos del estudio (por ejemplo, la espirometría).
    12. Participation en otro ensayo clínico con un fármaco en investigación en los 2 meses anteriores a visita 1.
    13. Patientes crónicos que requieren ventilación mecánica para la EPOC
    E.5 End points
    E.5.1Primary end point(s)
    - AUC0-30min normalizada por tiempo de cambio desde la FEV1 pre-dosis hasta después de la toma de medicación en la mañana del día 1 (V2);
    - Puntuación del índice de Transition Disnea (TDI) del día 84 (V5).
    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 Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 480
    F.4.2.2In the whole clinical trial 506
    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 Decision2011-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-03-13
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