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    Summary
    EudraCT Number:2010-019802-17
    Sponsor's Protocol Code Number:205.438
    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:2010-09-22
    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 number2010-019802-17
    A.3Full title of the trial
    Ensayo clínico aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para confirmar eficacia y seguridad del tratamiento durante 12 semanas con tiotropio 5mcg una vez al día inhalado via Respimat® en pacientes con fibrosis quística.
    A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 mcg administered once daily via the Respimat® device in patients with cystic fibrosis.
    A.4.1Sponsor's protocol code number205.438
    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 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 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 Spiriva Respimat 2.5 microgram, solution for inhalation
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim Pharma GmbH Co. KG
    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 nameSpiriva Respimat 2.5 mcg
    D.3.2Product code Tiotropium Respimat
    D.3.4Pharmaceutical form Inhalation vapour, 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.3.9.1CAS number 411207313
    D.3.9.2Current sponsor codeBa 679 Br
    D.3.9.3Other descriptive nameTIOTROPIUM BROMIDE MONOHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.124
    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 vapour*
    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
    Fibrosis Quística
    Cystic Fibrosis
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal es confirmar la eficacia y superioridad al cabo de 12 semanas de tiotropio 5 &#956;g en comparación con placebo y aportar datos de seguridad durante un mínimo de 6 meses.
    The primary objective is to confirm the 12-week efficacy and superiority of tiotropium 5 mcg compared to placebo and to provide safety data over a minimum of 6 months.

    El objetivo principal es confirmar la eficacia y superioridad de 5 mcg de tiotropio en comparación con placebo administrado via dispositivo Respimat® durante 12 semanas y proporcionar datos de seguridad durante un mínimo de 6 meses.
    E.2.2Secondary objectives of the trial
    1. Cambio del valor basal en el % de FVC (AUC0-4H) tras 12 semanas de tratamiento. 2. Cambio del valor basal en el % de FVC valle (trough) tras 12 semanas de tratamiento. 3. Cambio del valor basal del FEF 25-75 pre-broncodilatador tras 12 semanas de tratamiento. 4. Proporción de pacientes con al menos 1 exacerbación durante el periodo de tratamiento determinado con questionario RSSQ;definición dada por Fuchs et al. 5. Cambio del valor basal de cuestionario CFQ-R tras 12 semanas de tratamiento.
    1. Change from baseline in % predicted FVC (AUC0-4H) at 12 weeks. 2. Change from baseline in % predicted trough FVC at 12 weeks. 3. Change from baseline in pre-bronchodilator mean FEF between 25 -75% of FVC (FEF25-75) at 12 weeks. 4. Proportion of patients with at least 1 pulmonary exacerbation during t treatment period as assessed by RSSQ questionnaire; definition as given in Fuchs et al. 5. Change from baseline in CFQ-R questionnaire at 12 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnóstico de FQ documentado.
    2. Pacientes de ambos sexos (niños menores de 12 años y adolescentes ? 12 años). Solamente para la evaluación de seguridad pueden incluirse en el ensayo pacientes menores de 1 año de edad, si son elegibles.
    3. Los pacientes ? 5 años de edad deben ser capaces de realizar maniobras espirométricas aceptables.
    4. FEV1 pre-broncodilatador > 25% de los valores teóricos:Pediátricos/adolescentes (? 5 años hasta 18 años de edad, incluidos): Ecuaciones de Wang X et al. Adultos (> 18 años): Ecuaciones de Knudson RJ et al. Cambios en la curva del volumen/ flujo espiratorio máximo normal con crecimiento.
    5. Los pacientes deben ser capaces de inhalar la medicación de forma reproducible.
    6. El FEV1 pre-broncodilatador en la Visita 2 debe situarse en un margen del 15% del FEV1 en la Visita 1.
    7. Paciente sintomáticamente estable estable en las 2 semanas anteriores a la selección (Visita 1): Ausencia de indicios de infección aguda del tracto respiratorio superior o inferior en las 2 semanas previas a la selección (Visita 1) y ausencia de exacerbación pulmonar que requiera el uso de antibióticos i.v./oral/inhalados, o de corticoesteroides orales
    8. El paciente o el representante legal del paciente debe ser capaz de dar su consentimiento informado de conformidad con las directrices BPC, ICH y la legislación nacional antes de participar en el ensayo.
    9. Los pacientes que sigan el régimen de ciclos TOBI® deben haber completado al menos 2 ciclos de TOBI® en meses alternos antes de la visita de selección. El último ciclo TOBI® deberá haberse completado 2 semanas antes de la visita de aleatorización (visita 2).
    10. Los pacientes que siguen un tratamiento diario con antibióticos por inhalación deben estar estables durante al menos 6 semanas antes de la Visita 1 (selección).
    11. Los pacientes que hayan participado previamente en el estudio 205.339 podrán ser seleccionados.
    1. Diagnoses of CF (positive sweat chloride ? 60 mEq/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF accompanied by one or more clinical features with the CF phenotype.
    2. Male or female patients (children less than 12 years and adolescents ? 12 years). Patients below 1 year of age, if eligible, can be included in the trial only for safety assessment.
    3. Patients ? 5 years of age must be able to perform acceptable spirometric maneuvers, according to the American Thoracic Society (ATS) standards.
    4. Pre-bronchodilator FEV1 >25% of predicted values:
    pediatric/adolescent (? 5 years up to 18 years of age, inclusive) predicted equations from: Wang X et al.
    adult (>18 years) predicted equations from: Knudson RJ et al. Changes in normal maximal expiratory flow-volume curve with growth.
    5. Patients must be able to inhale medication in a reproducible manner from the Respimat® inhaler and from a metered dose inhaler (MDI) for children of 5 years and above. For children below 5 years, patients must be able to inhale medication in a reproducible manner from the Respimat® inhaler with spacer (the Aerochamber plus® holding chamber with facemask).
    6. Pre-bronchodilator FEV1 at Visit 2 must be within 15% of FEV1 at Visit 1. If pre-bronchodilator FEV1 at Visit 2 is not within 15% of FEV1 at Visit 1, Visit 2 can be repeated within 7 days and rescheduled once.
    7. Investigator should also ascertain that the patient is symptomatically stable as defined by: 1. no evidence of acute upper or lower respiratory tract infection within 2 weeks of screening (Visit 1) and 2. no pulmonary exacerbation requiring use of i.v./oral/inhaled antibiotics, or oral corticosteroids within 2 weeks of screening (Visit 1).
    8. The patient or the patient?s legally acceptable representative must be able to give informed consent in accordance with ICH, GCP guidelines and local regulation prior to participation in the trial.
    9. Patients who are on a cycling TOBI® regimen must have completed at least 2 cycles every other month TOBI® administration prior to the screening visit. The last TOBI® cycle should have been completed 2 weeks before randomisation visit (visit 2). For other inhaled antibiotics (e.g., colistin, aztreonam), please contact the local clinical monitor (CML) for guidance. For TOBI® cycling during the trial please refer to section 4.2.1.2.
    10. Patients who are on daily inhaled antibiotic use must be stabilized for at least 6 weeks prior to Visit 1 (screening).
    11. Patients having previously participated in study 205.339 can also be selected.
    E.4Principal exclusion criteria
    1. Pacientes con hipersensibilidad conocida al fármaco del estudio o a sus componentes.
    2. Pacientes que hayan participado en otro estudio con un fármaco en investigación en el mes previo a la visita de selección.
    3. Pacientes que estén participando en otro ensayo en la actualidad. Se permiten los estudios observacionales. Debe obtenerse autorización del promotor del otro estudio.
    4. Pacientes con abuso conocido y relevante de sustancias, incluidos el alcohol y las drogas. El objetivo de este criterio es excluir a los pacientes que se considera que corren riesgo de no cumplir o de abusar de las directrices de administración de la medicación del ensayo.
    5. Pacientes adolescentes y adultas que estén embarazadas o en período de lactancia, incluidas las mujeres que hayan tenido un resultado positivo en la prueba de embarazo en suero en la selección (se realizarán pruebas de embarazo a todas las adolescentes y mujeres adultas en edad fértil).
    6. Pacientes de sexo femenino en edad fértil que no estén utilizando un método anticonceptivo autorizado desde el punto de vista médico. La ICH (M3) estableció métodos anticonceptivos altamente efectivos como aquellos que, solos o en combinación, dan lugar a una tasa de fracaso baja (menor al 1% por año) cuando se utilizan de forma continuada y correctamente. En el caso de las pacientes que utilicen un método anticonceptivo hormonal, debe abordarse la información acerca del producto en investigación y su posible efecto sobre el anticonceptivo. Los anticonceptivos de barrera (p. ej.: preservativo masculino o diafragma) están aceptados si se usan combinados con espermicidas (p. ej.: espuma o gel).
    7. Pacientes que hayan comenzado un nuevo tratamiento farmacológico crónico para la FQ dentro de las 2 semanas anteriores a la visita de selección (Visita 1).
    8. Enfermedades clínicamente significativas o afecciones médicas que no sean la FQ ni afecciones relacionadas con la FQ que, a juicio del Investigador, podrían poner en peligro la seguridad del paciente o la calidad de los datos. Aquí se incluyen, aunque no son las únicas, enfermedades hematológicas, hepáticas, renales, cardiovasculares y neurológicas significativas. Los pacientes con diabetes pueden participar si su enfermedad está bien controlada antes de la selección. Este criterio da al investigador la posibilidad de excluir a pacientes según su juicio clínico, aunque se cumplan otros criterios de elegibilidad.
    1. Patients with a known hypersensitivity to study drug or its components
    2. Patients who have participated in another study with an Investigational drug within one month preceding the screening visit.
    3.Patients who are currently participating in another trial. Observational studies are allowed. Permission should be obtained from sponsor of other study.
    4. Patients with known relevant substance abuse, including alcohol or drug abuse. The intention of this criterion is to exclude patients who are considered to be at risk of not complying with or abusing the trial medication administration directives.
    5. Adolescent and adult female patients who are pregnant or lactating, including females who have a positive serum pregnancy test at screening (pregnancy tests will be performed for all adolescent and adult females of child bearing potential).
    6. Female patients of child bearing potential who are not using a medically approved form of contraception. The ICH (M3) defined highly effective methods of birth control as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. For patients using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed. Barrier contraceptives (e.g. male condom or diaphragm) are acceptable if used in combination with spermicides (e.g. foam gel).Refer to ICH Topic M3 provided in the ISF.
    7. Patients who have started a new chronic medication for CF within 2 weeks before the screening visit (Visit 1).
    8. Clinically significant disease or medical condition other than CF or CF-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This includes but is not limited to significant haematological, hepatic, renal, cardiovascular, and neurologic disease. Patients with diabetes may participate if their disease is under good control prior to screening. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied.
    E.5 End points
    E.5.1Primary end point(s)
    Los criterios co-principales de valoración en este ensayo son:
    1. Cambio del valor basal del porcentaje del teórico del volumen espiratorio forzado en un segundo (FEV1) área bajo la curva (AUC0-4h) respecto al valor final en la semana 12 .
    2. Cambio del valor basal del porcentaje del teórico del FEV1 valle (trough) respecto al valor en la semana 12.
    The co-primary endpoints for this trial are:
    1. Change from baseline in percent predicted forced expiratory volume in one second (FEV1) area under the curve (AUC0-4H) after 12 weeks.
    2. Change from baseline in percent predicted trough FEV1at 12 weeks.
    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 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 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 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 Yes
    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 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 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
    Fin del ensayo = última visita del último paciente en el ensayo.

    End of the trial = last visit of the last patient undergoing the trial.
    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 months3
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days21
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children less than11 years old inclusive
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 360
    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)
    tratamiento habitual de la enfermedad
    normal treatment of the 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 Decision2010-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-04
    P. End of Trial
    P.End of Trial StatusCompleted
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