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    Summary
    EudraCT Number:2014-002275-28
    Sponsor's Protocol Code Number:1237.19
    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:2014-11-25
    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 number2014-002275-28
    A.3Full title of the trial
    A randomised, double-blind, active-controlled parallel group study to evaluate the effect of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination compared with tiotropium on Chronic Obstructive Pulmonary Disease (COPD) exacerbation in patients with severe to very severe COPD. [DYNAGITO]
    Ensayo clínico, aleatorizado, doble ciego, con control activo y de grupos paralelos para evaluar el efecto sobre las exacerbaciones del tratamiento una vez al día oral inhalado de la combinación a dosis fijas de tiotropio+olodaterol comparado con tiotropio durante 52 semanas en pacientes con Enfermedad Pulmonar Obstructiva Crónica grave a muy grave. [DYNAGITO]
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparing the efficacy of tiotropium + olodaterol (5/5 µg) fixed dose combination (FDC) over tiotropium 5µg in reducing moderate to severe exacerbations in patients with severe to very severe Chronic Obstructive Pulmonary Disease.
    Comparación de la eficacia de la combinación tiotropio + olodaterol a dosis fija (5/5 ?g) comparado con 5?g de tiotropio en la reducción moderada de las exacerbaciones graves en pacientes con enfermedad pulmonar obstructiva crónica grave a muy grave.
    A.3.2Name or abbreviated title of the trial where available
    DYNAGITO
    A.4.1Sponsor's protocol code number1237.19
    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+34934045100
    B.5.5Fax number+34934045580
    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.3.1Product nameTiotropium 2.5?g/Olodaterol 2.5?g
    D.3.4Pharmaceutical form Inhalation 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 186691-13-4
    D.3.9.3Other descriptive nameTIOTROPIUM
    D.3.9.4EV Substance CodeSUB25691
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNolodaterol
    D.3.9.1CAS number 868049-49-4
    D.3.9.3Other descriptive nameOLODATEROL
    D.3.9.4EV Substance CodeSUB36104
    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 Yes
    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.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 Respimat 2.5 microgram
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International 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.3.4Pharmaceutical form Inhalation 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 186691-13-4
    D.3.9.3Other descriptive nameTIOTROPIUM
    D.3.9.4EV Substance CodeSUB25691
    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 Yes
    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
    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
    Enfermedad Pulmonar Obstructiva Crónica
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease
    N/A
    Enfermedad Pulmonar Obstructiva Crónica
    N/A
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect of Tiotropium + Olodaterol on COPD exacerbations
    Comparar el efecto de Tiotropio + Olodaterol sobre las exacerbaciones en EPOC
    E.2.2Secondary objectives of the trial
    To compare the effect of Tiotropium + Olodaterol on hospitalisation associated with exacerbations and survival
    Comparar el efecto de Tiotropio + Olodaterol en la hospitalización asociada con las exacerbaciones y la supervivencia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female patients, 40 years of age or older.
    - Diagnosis of COPD with a documented post-bronchodilator Forced expiratory volume in one second (FEV1)< 60% of predicted normal and a post-bronchodilator FEV1/FVC (Forced vital capacity) <70% at Visit 1
    - Documented history of at least one moderate to severe COPD exacerbation in the previous 12 months requiring treatment with systemic corticosteroids and/or antibiotics and/or related hospitalization.
    - Symptomatically stable as defined by: no evidence of COPD exacerbation requiring use of either antibiotics and/or steroids 4 weeks prior to visit 1 and no evidence of change in their usual COPD medication 4 weeks prior to visit 1.
    - Current or ex-smokers with a smoking history of more than 10 pack years.
    - Pacientes de ambos sexos de 40 años en adelante.
    - Presentar un diagnóstico de EPOC con un valor del FEV1 posbroncodilatador < 60 % del valor normal previsto y un valor posbroncodilatador del cociente FEV1/FVC < 70 % en la visita 1
    - Antecedentes diagnosticados de al menos una exacerbación de moderada a grave de la EPOC en los 12 meses previos, que necesitó tratamiento con corticosteroides sistémicos y/o antibióticos y/o con una hospitalización relacionada.
    - Sintomáticamente estable según lo siguiente: Sin signos de exacerbación de la EPOC que requiera el uso de antibióticos y/o corticosteroides 4 semanas antes de la visita 1 y sin signos de cambios en la medicación habitual para la EPOC 4 semanas antes de la visita 1.
    - Fumadores o exfumadores con antecedentes de tabaquismo de más de 10 paquetes-año.
    E.4Principal exclusion criteria
    - Significant disease other than COPD.
    - Clinically relevant abnormal baseline haematology, blood chemistry, urinalysis or creatinine > x2 ULN will be excluded regardless of clinical condition
    - Current documented history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma
    - A diagnosis of thyrotoxicosis
    - A history of myocardial infarction within 6 months of screening visit.
    - Life-threatening cardiac arrhythmia.
    - Known active tuberculosis.
    - Any malignancy unless free of disease for at least 5 years (patients with treated basal cell carcinoma or squamous cell skin cancers are allowed).
    - A history of cystic fibrosis.
    - Clinically relevant bronchiectasis.
    - Patients with severe emphysema requiring endobronchial interventions within 6 months prior to screening
    - A history of significant alcohol or drug abuse in the opinion of the investigator.
    - Patients who have undergone thoracotomy with pulmonary resection
    - Patients being treated with oral or patch ß-adrenergics.
    - Patients being treated with oral corticosteroid medication at unstable doses
    - Patients being treated with PDE4 inhibitors within 3 months of screening visit
    - Patients who have taken an investigational drug within one month or six half-lives
    - Pregnant or nursing women.
    - Women of childbearing potential not using a highly effective method of birth control.
    - Enfermedad importante diferente de EPOC
    - Resultados basales anormales con alteraciones clínicamente significativas del hemograma, la bioquímica, del análisis de orina o la creatinina > 2 veces el ULN serán excluidos, con independencia de su estado clínico
    - Pacientes con antecedentes de asma. En pacientes con rinitis alérgica o atopia se requiere documentación original para verificar que el paciente no padece asma.
    - Diagnóstico de tirotoxicosis
    - Antecedentes de infarto de miocardio en los 6 meses previos a la visita de selección.
    - Arritmia cardíaca potencialmente mortal
    - Tuberculosis activa conocida
    - Cualquier neoplasia maligna, a menos que el paciente esté libre de enfermedad durante como mínimo 5 años (se permite la inclusión de pacientes con carcinoma basocelular o cáncer espinocelular tratados).
    - Antecedentes de fibrosis quística.
    - Bronquiectasia clínicamente relevante
    - Pacientes con enfisema grave que requiere intervenciones endobronquiales en los 6 meses previos a la selección.
    - Antecedentes de consumo significativo de alcohol o drogas
    - Pacientes que hayan sido sometidos a toracotomía con resección pulmonar
    - Pacientes en tratamiento con adrenérgicos ? orales o en parches
    - Pacientes en tratamiento con corticosteroides orales a dosis inestables
    - No se podrá incluir a los pacientes tratados con inhibidores de la PDE4 en los 3 meses previos a la visita de selección
    - Pacientes que hayan recibido un fármaco en fase de investigación en el plazo de un mes o seis semividas
    - Mujeres embarazadas o en periodo de lactancia
    - Mujeres fértiles que no utilicen un método anticonceptivo altamente
    E.5 End points
    E.5.1Primary end point(s)
    1: Primary endpoint: annualised rate of moderate to severe COPD exacerbation during the treatment period (within 1 day after the last drug administration date).
    1: Criterio principal de valoración: Tasa anualizada de exacerbaciones de moderadas a graves de la EPOC durante el periodo de tratamiento (hasta 1 día después de la última fecha de administración del fármaco).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: 52 weeks + 1 day

    2: 52 weeks+ 1 day
    1: 52 semanas + 1 día

    2: 52 semanas + 1 día
    E.5.2Secondary end point(s)
    1: Key secondary endpoint: time to first moderate to severe COPD exacerbation during the treatment period (within 1 day after the last drug administration date).

    2: Time to all-cause mortality (within 1 day after the last drug administration date).

    3: Annualised rate of exacerbation leading to hospitalisation during the treatment period (within 1 day after the last drug administration date).

    4: Time to first COPD exacerbations leading to hospitalisation during the treatment period (within 1 day after the last drug administration date).
    1: Segundo criterio de valoración principal: Tiempo hasta la primera exacerbación de moderada a grave de la EPOC durante el periodo de tratamiento (hasta 1 día después de la última fecha de administración del fármaco).

    2: Tiempo hasta mortalidad por cualquier causa (hasta 1 día después de la última fecha de administración del fármaco).

    3: Tiempo hasta la primera exacerbación de la EPOC que provocan la hospitalización durante el periodo de tratamiento (hasta 1 día después de la última fecha de administración del fármaco).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: 52 weeks + 1 day

    2: 52 weeks + 1 day

    3: 52 weeks + 1 day

    4: 52 weeks + 1 day
    1: 52 semanas + 1 día

    2: 52 semanas + 1 día

    3: 52 semanas + 1 día

    4: 52 semanas + 1 día
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA323
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Croatia
    Czech Republic
    Denmark
    Ecuador
    Finland
    France
    Germany
    Greece
    Guatemala
    Hong Kong
    Hungary
    India
    Ireland
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lebanon
    Lithuania
    Malaysia
    Mexico
    Montenegro
    Netherlands
    New Zealand
    Norway
    Philippines
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Singapore
    Slovakia
    Slovenia
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    Thailand
    Tunisia
    Turkey
    Ukraine
    United Kingdom
    United States
    Vietnam
    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
    LVLS
    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 months2
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days20
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7000
    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 state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3380
    F.4.2.2In the whole clinical trial 8200
    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)
    none
    ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4 Investigator Network to be involved in the Trial: 2
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-29
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