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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   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:2022-001805-40
    Sponsor's Protocol Code Number:TRICORDA
    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:2023-03-24
    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 number2022-001805-40
    A.3Full title of the trial
    Increase in inhaled corticosteroid dose vs triple therapy in T2-high asthma patients who remain uncontrolled with medium dose inhaled corticosteroids/long-acting β2 adrenergic combination: a real-life study. TRICORDA Study (Triple vs Inhalados CORticoides a Dosis Altas).
    Aumento en la dosis del corticoide inhalado vs triple terapia en pacientes con asma T2-alta que no alcanzan el control con dosis medias de combinación corticoide inhalado/beta-agonistas de larga duración: estudio en vida real. Estudio TRICORDA (Triple vs Inhalados CORticoides a Dosis Altas).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Increase in inhaled corticosteroid dose vs triple therapy in T2-high asthma patients who remain uncontrolled : a real-life study. TRICORDA Study
    Aumento en la dosis del corticoide inhalado vs triple terapia en pacientes con asma T2-alta que no alcanzan el control : estudio en vida real. Estudio TRICORDA
    A.3.2Name or abbreviated title of the trial where available
    TRICORDA
    TRICORDA
    A.4.1Sponsor's protocol code numberTRICORDA
    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 SponsorHospital Universitario Lucus Augusti
    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 supportSEPAR
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Instituto de Investigación Sanitaria de Santiago de Compostela
    B.5.2Functional name of contact pointFIDIS
    B.5.3 Address:
    B.5.3.1Street AddressC/Ulises Romero 1
    B.5.3.2Town/ cityLugo
    B.5.3.3Post code27003
    B.5.3.4CountrySpain
    B.5.4Telephone number34982296698
    B.5.6E-mailinvestigacionlugo.fidis@sergas.es
    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.2.1.2Country 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.3.4Pharmaceutical 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 INNBudesonide
    D.3.9.1CAS number 51333-22-3
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBeclometasone
    D.3.9.1CAS number 4419-39-0
    D.3.9.4EV Substance CodeSUB05678MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMometasone
    D.3.9.1CAS number 105102-22-5
    D.3.9.4EV Substance CodeSUB09045MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFluticasone furoate
    D.3.9.1CAS number 397864-44-7
    D.3.9.4EV Substance CodeSUB26593
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFluticasone propionate
    D.3.9.1CAS number 80474-14-2
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTiotropium bromide
    D.3.9.1CAS number 139404-48-1
    D.3.9.4EV Substance CodeSUB11095MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVilanterol
    D.3.9.1CAS number 503068-34-6
    D.3.9.4EV Substance CodeSUB77409
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma is an important global health problem that affects people of all ages . Despite effective and safe therapeutic options, up to 75% of patients with asthma remain uncontrolled . It remains to be clarified whether triple therapy is better than high dose ICS/LABA in patients with uncontrolled asthma despite the use of medium dose ICS/LABA combinations, particularly in cases with high T2 biomarkers values.
    El asma es un importante problema de salud mundial que afecta a personas de todas las edades . A pesar de las opciones terapéuticas eficaces y seguras, hasta el 75% de los pacientes con asma siguen sin estar controlados . Queda por aclarar si la triple terapia es mejor que las dosis altas de CSI/LABA en los pacientes con asma no controlada a pesar del uso de combinaciones de dosis medias de CSI/LABA, especialmente en los casos con valores elevados de biomarcadores T2.
    E.1.1.1Medical condition in easily understood language
    Asthma is an important global health problem that affects people of all ages . Despite effective and safe therapeutic options, up to 75% of patients with asthma remain uncontrolled.
    El asma es un importante problema de salud mundial que afecta a personas de todas las edades . A pesar de las opciones terapéuticas eficaces, el 75% de los pacientes siguen sin estar controlados.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Hypothesis.
    Triple therapy with medium dose ICS/LABA/LAMA is non-inferior to high dose ICS/LABA (the approach currently suggested by Guidelines) to achieve control (both Asthma control test ≥ 20 and no exacerbations) in patients with T2-high asthma (defined as either > 300 cels/mm3 blood eosinophils or exhaled nitric oxide ≥ 25 ppb).
    Objectives.
    -Main objective: The primary endpoint will be to compare in both treatment arms the percentage of patients controlled at week 52, with both an Asthma Control Test (ACT) score of 20 or greater and no severe exacerbations.
    Hipótesis.
    El tratamiento triple con dosis medias de CSI/LABA/LAMA no es inferior a las dosis altas de CSI/LABA (el enfoque actualmente sugerido por las Guías) para lograr el control (tanto un resultado del test de control del asma ≥ 20 como la ausencia de exacerbaciones) en pacientes con asma T2-alta (definida como > 300 cels/mm3 de eosinófilos en sangre o óxido nítrico exhalado ≥ 25 ppb).
    Objetivos.
    -Objetivo principal: El objetivo principal será comparar en ambos brazos de tratamiento el porcentaje de pacientes controlados en la semana 52 (puntuación del Test de Control del Asma (ACT) ≥ 20 y ausencia de exacerbaciones graves).
    E.2.2Secondary objectives of the trial
    To compare, the percentage of patients controlled at week 24, ACT at weeks 12, 24 and 52, Asthma Impairment and Risk Questionnaire (AIRQ) at weeks 12, 24 and 52, quality of life (Mini-AQLQ) at weeks 12, 24 and 52, postbronchodilator FEV1 at weeks 12, 24 and 52, severe exacerbations at week 24 and 52.
    To compare, the percentage of patients who achieved the minimal clinically important difference (MCID) in ACT and Mini-AQLQ at weeks 12, 24 and 52.
    Differences between groups in 8 AM serum cortisol at week 52.
    Adherence at week 52 in the two arms.
    Factors related to triple and high-dose ICS/LABA failure and success (control) at week 52.
    Safety endpoints will include:
    Incidence of serious adverse events of pneumonia during the study
    Time to first serious adverse event of pneumonia
    Deaths due to serious events of pneumonia
    Incidence and type of serious adverse events
    Incidence and type of adverse drug reactions
    Comparar el porcentaje de pacientes controlados en la semana 24, el ACT , el Cuestionario de Deterioro y Riesgo del Asma en las semanas 12, 24 y 52, la calidad de vida en las semanas 12, 24 y 52, el FEV1 posbroncodilatador en las semanas 12, 24 y 52, las exacerbaciones graves en la semana 24 y 52.
    Comparar el porcentaje de pacientes que alcanzaron la diferencia mínima clínicamente importante en el ACT y el Mini-AQLQ en las semanas 12, 24 y 52. Diferencias entre grupos en el cortisol sérico a las 8 AM en la semana 52.
    La adherencia semana 52 .
    Factores relacionados con el fracaso y el éxito de las dosis triples y altas de CSI/LABA en la semana 52.
    Los criterios de valoración de seguridad incluirán:
    Incidencia de acontecimientos adversos graves de neumonía
    Tiempo hasta el primer acontecimiento adverso grave de neumonía
    Muertes debidas a acontecimientos graves de neumonía
    Incidencia y tipo de acontecimientos adversos graves
    Incidencia y tipo de reacciones adversas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    o Patients between 18 and 80 years of age diagnosed of uncontrolled asthma.
    o T2 high asthma: > 300 cels/mm3 blood Eos (current value) or 150 cels/mm3 blood Eos (current value) and a historical value ≥ 300 cels/mm3 or FENO ≥ 25 ppb (current value).
    o Uncontrolled asthma, this is, ACT <20 and/or > 1 of an exacerbation in the last 12 months, despite treatment with ICS/LABA at medium dose.
    o Written informed consent.
    o Pacientes entre 18 y 80 años diagnosticados de asma no controlada.
    o Asma alta T2: > 300 células/mm3 de Eos en sangre (valor actual) o 150 células/mm3 de Eos en sangre (valor actual) y un valor histórico ≥ 300 células/mm3 o FENO ≥ 25 ppb (valor actual).
    o Asma no controlada, esto es, TCA <20 y/o > 1 de una exacerbación en los últimos 12 meses, a pesar del tratamiento con CSI/LABA a dosis medias.
    o Consentimiento informado por escrito.
    E.4Principal exclusion criteria
    o Patients who refuse to sign the informed consent form.
    o Medical situation that prevents the collection of study information.
    o Diagnosis of severe uncontrolled asthma established with criteria other than those established (ACT <20 and/or > 1 exacerbation in the last 12 months, despite treatment with ICS / LABA at medium dose).
    o Medical or administrative situation that prevents the patient from following up to a minimum of 52 weeks.
    o Treatment with high dose ICS/LABA, LAMA, systemic corticosteroid, azithromycin, monoclonal antibody.
    o Pacientes que se niegan a firmar el formulario de consentimiento informado.
    o Situación médica que impida la recogida de información del estudio.
    o Diagnóstico de asma grave no controlada establecido con criterios distintos a los establecidos (TCA <20 y/o > 1 exacerbación en los últimos 12 meses, a pesar del tratamiento con CSI / LABA a dosis medias).
    o Situación médica o administrativa que impida el seguimiento del paciente hasta un mínimo de 52 semanas.
    o Tratamiento con CSI/LABA a dosis altas, LAMA, corticoide sistémico, azitromicina, anticuerpo monoclonal.
    E.5 End points
    E.5.1Primary end point(s)
    -The primary endpoint will be the percentage of patients controlled at week 52, with an ACT score of 20 or higher and no severe exacerbations.
    -El criterio de valoración primario será el porcentaje de pacientes controlados en la semana 52, con una puntuación de ACT de 20 o superior y sin exacerbaciones graves.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Semana 52
    E.5.2Secondary end point(s)
    -Secondary endpoints: percentage of patients controlled at week 24, ACT at weeks 12, 24 and 52, AIRQ at weeks 12, 24 and 52, quality of life (Mini-AQLQ) at weeks 12, 24 and 52, post-bronchodilator FEV1 at weeks 12, 24 and 52, severe exacerbations at week 24 and 42, serum cortisol 8 AM at week 52. Adherence at week 52.
    -Criterios de valoración secundarios: porcentaje de pacientes controlados en la semana 24, ACT en las semanas 12, 24 y 52, AIRQ en las semanas 12, 24 y 52, calidad de vida (Mini-AQLQ) en las semanas 12, 24 y 52, FEV1 posbroncodilatador en las semanas 12, 24 y 52, exacerbaciones graves en la semana 24 y 42, cortisol sérico 8 AM en la semana 52. Adherencia en la semana 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12, 24 and 52
    Semana 12, 24 y 52
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 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 concerned42
    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
    last subject undergoing the trial
    último paciente en el ensayo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 620
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state620
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation SOCIEDAD ESPAÑOLA DE NEUMOLOGÍA Y CIRUGÍA TORÁCICA (SEPAR)
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-27
    P. End of Trial
    P.End of Trial StatusOngoing
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