Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-004427-20
    Sponsor's Protocol Code Number:CHHEF
    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:2019-12-02
    Trial 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 number2019-004427-20
    A.3Full title of the trial
    PHASE IV, SINGLE-CENTER, DOUBLE BLIND, RANDOMIZED, CROSSOVER, PLACEBO-CONTROLLED STUDY, TO INVESTIGATE THE EFFECT OF DUAL BRONCHODILATION WITH UMECLIDINIUM VILANTEROL ON PATIENTS WITH COPD, HYPERINFLATION AND HEART FAILURE.
    ESTUDIO FASE IV, DE UN SOLO CENTRO, DOBLE CIEGO, ALEATORIZADO, CRUZADO, CONTROLADO CON PLACEBO, PARA INVESTIGAR EL EFECTO DE LA BRONCODILACIÓN DUAL CON UMECLIDINIUM VILANTEROL EN PACIENTES CON EPOC, HIPERINSUFLACIÓN E INSUFCIENCIA CARDIACA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of dual bronchodilation with umeclidinium vilanterol on patients with COPD, hyperinflation and heart failure
    EFECTO DE LA BRONCODILACIÓN CON UMECLIDINIUM VILANTEROL EN PACIENTES CON EPOC, HIPERINSUFLACIÓN E INSUFCIENCIA CARDIACA
    A.3.2Name or abbreviated title of the trial where available
    CHHEF
    CHHEF
    A.4.1Sponsor's protocol code numberCHHEF
    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 SponsorLuis Puente Maestu
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGSK Supported Studies Program
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLuis Puente Maestu
    B.5.2Functional name of contact pointLuis Puente
    B.5.3 Address:
    B.5.3.1Street AddressDr. Esquerdo 46
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28007
    B.5.3.4CountrySpain
    B.5.4Telephone number+34914703910
    B.5.5Fax number+34915868328
    B.5.6E-mailluis.puente@salud.madrid.org
    D. IMP Identification
    D.IMP: 1
    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 Umeclidinium/vilanterol 55/22 mcg
    D.2.1.1.2Name of the Marketing Authorisation holderGSK
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameUmeclidinium/vilanterol
    D.3.4Pharmaceutical form Inhalation powder
    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 INNUMECLIDINIUM BROMIDE
    D.3.9.1CAS number 869113-09-7|
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB119778
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number55
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVILANTEROL TRIFENATATE
    D.3.9.1CAS number 503070-58-4
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB36527
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22
    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 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
    Chronic obstructive pulmonary diseases with Heart Failure with eyection ventricular ejection fraction between 35-50%
    Enfermedades pulmonares obstructivas crónicas con insuficiencia cardíaca con fracción de eyección entre el 35-50%.
    E.1.1.1Medical condition in easily understood language
    Chronic obstructive pulmonary diseases with Heart Failure with ejection ventricular ejection fraction between 35-50%
    Enfermedades pulmonares obstructivas crónicas con insuficiencia cardíaca con fracción de eyección entre el 35-50%.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10013108
    E.1.2Term Disease obstructive lung
    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 address the effect (compared with placebo) of umeclidinium+vilanterol 55/22 mcg on the increase in exercise stroke volume (from baseline).
    Determinar el efecto del tratamiento con umeclidinium/vilanterol 55/22 μg en comparación con placebo sobre el aumento del volumen sistólico durante el ejercicio en pacientes con EPOC,
    E.2.2Secondary objectives of the trial
    1. To address the effect (compared with placebo) of umeclidinium+vilanterol 55/22 mcg on the Reduction of dynamic hyperinflation (from baseline).
    2. To address the effect (compared with placebo) of umeclidinium+vilanterol 55/22 mcg on resting cardiac function (from baseline).
    3. To address the effect (compared with placebo) of umeclidinium+vilanterol 55/22 mcg on PROMs (from baseline) on
    Determinar el efecto del tratamiento con umeclidinium/vilanterol 55/22 μg en comparación con placebo sobre la hiperinsuflación pulmonar
    Determinar el efecto del tratamiento con umeclidinium/vilanterol 55/22 μg en comparación con placebo sobre disfunción ventricular izquierda leve a moderada.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged at least 40 years with a clinical diagnosis of COPD
    - Airflow limitation indicated by a screening post-bronchodilator FEV1 of less than 80% predicted and a post-bronchodilator FEV1 to forced vital capacity (FVC) ratio of less than 0.7
    - Smoking history of at least ten pack-years
    - Baseline lung hyperinflation with a residual volume of more than 135% predicted
    - Stable heart failure
    - Left ventricle ejection fraction in the range of 35% to 55%.
    - A suitable ultrasonic window from the apical view
    - Pacientes de al menos 40 años con diagnóstico clínico de EPOC
    - Limitación del flujo de aire indicada por un cribado post-broncodilatador FEV1 de menos del 80% previsto y un FEV1 post-broncodilatador con una relación de capacidad vital forzada (CVF) inferior al 0,7
    - Historial de tabaquismo de al menos 10 paquetes-año
    - Hiperinflación pulmonar de referencia con un volumen residual de más del 135% previsto
    - Insuficiencia cardíaca estable
    - Fracción de eyección del ventrículo izquierdo en el rango de 35% a 55%.
    - Una ventana ultrasónica adecuada desde la vista apical
    E.4Principal exclusion criteria
    - Do not sign the informed consent
    - Unstable cardiovascular diseases
    - Atrial fibrillation or other arrhythmias requiring treatment
    - Unstable ischemic heart disease
    - Uncontrolled hypertension.
    - Patients unable to undergo cardiac MR scanning (claustrophobia or carrying non MR-compatible devices)
    - Patients unable to perform exercise test (locomotor condtions)
    No firme el consentimiento informado
    - Enfermedades cardiovasculares inestables
    - Fibrilación auricular u otras arritmias que requieren tratamiento
    - Cardiopatía isquémica inestable
    - Hipertensión no controlada.
    - Pacientes que no pueden someterse a una RMN cardíaca (claustrofobia o portadores de dispositivos no compatibles con la RMN)
    - Pacientes que no pueden realizar la prueba de esfuerzo (patologías locomotoras)
    - inadecuada Ventana ecográfica desde la vista apical
    E.5 End points
    E.5.1Primary end point(s)
    1. Baseline-corrected, time-velocity integral (a direct surrogate of SV) during peak exercise, as measured by exercise Doppler-echocardiography (last satisfactory measurement).
    2. Maximal oxygen pulse on a cardiopulmonary exercise test on Cycle-ergometer
    1. baseline corregido, integral tiempo velocidad (un sustituto directo de la VS) durante el ejercicio máximo, medido por la ecocardiografía Doppler de ejercicio (última medición satisfactoria).
    2. Pulso máximo de oxígeno en una prueba de ejercicio cardiopulmonar en un cicloergómetro
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 14 days of washout patients will start either IMP or placebo. Two weeks afterworks all the endpoints there will be the firts evaluation. After another 14 days of washout the patients will be crossed over and expose to IMP or placebo for 14 days, point that wich a second evaluation
    Después de 14 días de lavado, los pacientes comenzarán con IMP o placebo. Dos semanas después , todos los puntos finales serán evaluados por primera vez. Después de otros 14 días de lavado, los pacientes serán cruzados y expuestos a IMP o placebo durante 14 días, punto en el que se realizará una segunda evaluación.
    E.5.2Secondary end point(s)
    1. Resting lung volumes ( Inspiratory capacity, functional residual capacity and residual volume)
    2. Inspiratory Capacity every 2 minutes during the incremental exercise test.
    3. Left and right cardiac chambers volumes at rest in patients, as measured by MRI
    4. Baseline-corrected peak ejection intraventricular pressure difference (peak EIVPD) at peak exercise, as measured by exercise color-Doppler M-mode echocardiography (last satisfactory measurement).
    5. Pulmonary acceleration time in the main pulmonary artery as measured by phase-contrast MRI.
    6. Baseline-corrected peak intraventricular diastolic pressure gradient (peak DIVPD) at peak exercise – diastolic suction, as measured by exercise color-Doppler M-mode echocardiography (last satisfactory measurement).
    7. ProBNP levels
    8. Average changes in COPD Assessment Test (CAT) and Transition dyspnea index
    9. Proportion of patients with Clinically relevant changes in COPD Assessment Test (CAT) and Transition dyspnea index ( -4 and -2 respectively)
    1. Volúmenes pulmonares en reposo (capacidad inspiratoria, capacidad funcional residual y volumen residual)
    2. Capacidad inspiratoria cada 2 minutos durante la prueba de ejercicio incremental.
    3. Volúmenes de las cámaras cardíacas izquierda y derecha en reposo en pacientes, medidos por RMN
    4. Diferencia de presión intraventricular de eyección pico corregida con basal (EIVPD pico) en el ejercicio máximo, medido mediante ecocardiografía con modo M Doppler a color de ejercicio (última medición satisfactoria).
    5. Tiempo de aceleración pulmonar en la arteria pulmonar principal medido por RMN con contraste de fase.
    6. Gradiente de presión diastólica intraventricular pico corregido por basal (DIVPD pico) en el ejercicio pico - succión diastólica, medido por ecocardiografía de ejercicio en color-Doppler modo M (última medición satisfactoria).
    7. Niveles de ProBNP
    8. Cambios medios en la prueba de evaluación de la EPOC (CAT) y en el índice de disnea de transición
    9. Proporción de pacientes con cambios clínicamente relevantes en la prueba de evaluación de la EPOC (CAT) y en el índice de disnea de transición ( -4 y -2 respectivamente)
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 14 days of washout patients will start either IMP or placebo. Two weeks afterworks all the endpoints there will be the firts evaluation. After another 14 days of washout the patients will be crossed over and expose to IMP or placebo for 14 days, point that wich a second evaluation
    Después de 14 días de lavado, los pacientes comenzarán con IMP o placebo. Dos semanas después , todos los puntos finales serán evaluados por primera vez. Después de otros 14 días de lavado, los pacientes serán cruzados y expuestos a IMP o placebo durante 14 días, punto en el que se realizará una segunda evaluación.
    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 No
    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) 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 No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 + 30 days
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state60
    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)
    Patients will be follow 30 days after the treatment
    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 Decision2020-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-10
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 19 00:29:49 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA