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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2006-001009-27
    Sponsor's Protocol Code Number:205.372
    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:2012-03-30
    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 number2006-001009-27
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Long Term (one year) Efficacy and Safety Study of Tiotropium Inhalation Solution 5µg (2 puffs of 2.5µg) Delivered by the Respimat Inhaler in Patients with Chronic Obstructive Pulmonary Disease (COPD)
    Ensayo aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para valorar la eficacia y seguridad a largo plazo (1 año) de Tiotropio en solución para inhalar con el dispositivo Respimat®, 5 mcg (2 inhalaciones de 2.5 mcg), en pacientes con Enfermedad Pulmonar Obstructiva Crónica (EPOC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    -
    A.4.1Sponsor's protocol code number205.372
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBoehringer Ingelheim España, 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 supportBoehringer Ingelheim España, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+1-800-243-0127
    B.5.5Fax number+1-800-821-7119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.com
    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.3.2Product code Tiotropium/Respimat inhaler
    D.3.4Pharmaceutical form Inhalation vapour, solution
    D.3.4.1Specific paediatric formulation No
    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 411207-31-3
    D.3.9.2Current sponsor codeBA 679 BR
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 vapour, solution
    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
    Chronic Obstructive Pulmonary Disease (COPD).
    Enfermedad Pulmonar Obstructiva Crónica (EPOC).
    E.1.1.1Medical condition in easily understood language
    -
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    -
    El objetivo general de este estudio es evaluar la eficacia y la seguridad a largo plazo (1 año) de la solución para inhalación de tiotropio 5 mcg (2 inhalaciones de 2,5 mcg) administrado con el inhalador Respimat®, comparado con placebo, en pacientes con EPOC.

    El objetivo principal será la comparación de la eficacia broncodilatadora (mediante la respuesta FEV1 trough) tras un año de tratamiento y el impacto del tratamiento sobre el tiempo transcurrido hasta la aparición de la primera exacerbación de EPOC.
    E.2.2Secondary objectives of the trial
    -
    Los objetivos secundarios incluyen la evaluación de la eficacia broncodilatadora (FEV1 trough y FVC trough) a determinados tiempos y otras variables relacionadas con el impacto en las exacerbaciones de EPOC.

    Los objetivos secundarios adicionales del estudio están relacionados con la evaluación de la seguridad del tratamiento con solución para inhalación de tiotropio 5 mcg (2 inhalaciones de 2,5 mcg) administrado con el inhalador Respimat®, comparado con placebo, a largo plazo (1 año). Las evaluaciones de seguridad incluirán la monitorización de acontecimientos adversos y exploración física y ECG de 12 derivaciones pre y post estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -
    Pacientes de cualquier sexo de 40 años o más, con diagnóstico realativamente estable de EPOC de moderado a severo, con historial de fumador de al menos 10 Paquete- años podrán ser incluidos en el estudio. Los pacientes deberán tener un valor de FEV1 pre-broncodilatador ? 60% del teórico y un valor de FEV1 ? 70% del FVC, ambos tanto en la visita de selección (visita 1) como en el momento de la aleatorización (visita 2).
    E.4Principal exclusion criteria
    -
    Los principales criterios de exclusión se resumen a continuación:

    Enfermedades importantes además de la EPOC. Una enfermedad importante se define como una enfermedad o proceso que, en opinión del investigador, pueda suponer un riesgo para el paciente si participa en el estudio o pueda influir en los resultados del estudio o en la capacidad del paciente para participar en el estudio.
    Antecedentes recientes (es decir, seis meses o menos) de infarto de miocardio.
    Arritmia cardiaca inestable o potencialmente mortal que exija intervención o cambio en el tratamiento farmacológico respecto al último año.
    Hospitalización por insuficiencia cardiaca durante el año anterior.
    Cáncer que haya requerido resección, radioterapia o quimioterapia durante los últimos cinco años.
    Glaucoma de ángulo cerrado conocido.
    Pacientes con antecedentes de asma, rinitis alérgica o recuento de eosinófilos en sangre ? 600/mm3.
    Pacientes con obstrucción pulmonar potencialmente mortal o antecedentes de fibrosis quística o bronquiectasia clínicamente evidente.
    Tuberculosis activa conocida.
    Pacientes con antecedentes de alcoholismo o drogodependencia, o dependencia activa del alcohol u otras drogas.
    Pacientes que se hayan sometido a toracotomía con resección pulmonar.
    Pacientes que usen regularmente oxigenoterapia diurna durante más de una hora al día.
    Uso de corticosteroides sistémicos en dosis inestables (es decir, menos de seis semanas con una dosis estable) o en dosis superiores al equivalente a 10 mg de prednisolona al día o 20 mg en días alternos.
    Hipersensibilidad conocida a los anticolinérgicos, el CB, el EDTA o cualquier otro componente del sistema de administración de la solución para inhalación Respimat®.
    Mujeres embarazadas o en periodo de lactancia, o mujeres en edad fértil que no utilicen un método anticonceptivo médicamente aprobado.
    E.5 End points
    E.5.1Primary end point(s)
    -
    Existirán dos variables co-primarias para este studio: FEV1 trough y tiempo hasta la primera exacerbación.

    La eficacia broncodilatadora será evaluada mediante la respuesta FEV1 trough.
    FEV1 trough se define como el FEV1 medido 10 minutos antes del final del intérvalo de dosis (24 horas después de la administración del fármaco).
    La respuesta del FEV1 trough se define como el cambio respecto al valor basal.
    El valor basal de FEV1 será el valor pre-tratamiento medido en la visita 2 por la mañana 10 minutos antes de la administración de la primera dosis de medicación del estudio.

    El efecto de triotropio en las exacerbaciones de EPOC vendrá principalmente determinado por el tiempo transcurrido hasta la aparición de la primera exacerbación de moderada a severa de la EPOC (de acuerdo con las definiciones proporcionadas en el protocolo del estudio).
    E.5.1.1Timepoint(s) of evaluation of this end point
    -
    E.5.2Secondary end point(s)
    -
    E.5.2.1Timepoint(s) of evaluation of this end point
    -
    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 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) 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 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.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA140
    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
    Australia
    Brazil
    Canada
    China
    Denmark
    Finland
    France
    Germany
    Greece
    Hong Kong
    Hungary
    India
    Ireland
    Italy
    Korea, Republic of
    Lithuania
    Malaysia
    Mexico
    Netherlands
    Norway
    Poland
    Singapore
    Slovakia
    South Africa
    Spain
    Sweden
    Switzerland
    Turkey
    United Kingdom
    United States
    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
    -
    Momento en que todos los pacientes aleatorizados hayan completado su participación en el estudio, todas las discrepancias en los datos hayan sido resueltas y la base de datos del ensayo haya sido cerrada.
    El promotor se reserva el derecho de discontinuar el ensayo anticipadamente por imposibilidad de alcanzar los objetivos de reclutamiento o por información de eficacia o seguridad que podría afectar significativamente la continuidad del ensayo.
    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 months6
    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 months6
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1911
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2080
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 3000
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    -
    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 Decision2006-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-01-13
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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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