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    Summary
    EudraCT Number:2021-004972-32
    Sponsor's Protocol Code Number:CQVM149C2201
    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:2022-04-27
    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 number2021-004972-32
    A.3Full title of the trial
    A Phase II, double-blind, randomized, multiple dose, cross over, three-treatment, three-period, six sequence placebo controlled trial to evaluate efficacy, pharmacokinetics (PK), pharmacodynamics (PD) and safety and tolerability of glycopyrronium (bromide) in children from 6 to less than 12 years of age with asthma
    Ensayo clínico de fase II, doble ciego, aleatorizado, de múltiples dosis, cruzado, de tres tratamientos, tres períodos y seis secuencias, controlado con placebo, para evaluar la eficacia, farmacocinética, farmacodinámica, la seguridad y la tolerabilidad de bromuro de glicopirronio en niños con asma de 6 a menos de 12 años de edad
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetics, pharmacodynamics, safety and tolerability of glycopyrronium (bromide) in children (6 to less than 12 years) with asthma.
    Farmacocinética, farmacodinámica, seguridad y tolerabilidad de bromuro de glicopirronio en niños con asma (de 6 a menos de 12 años de edad).
    A.3.2Name or abbreviated title of the trial where available
    Pharmacokinetics, pharmacodynamics, safety and tolerability of glycopyrronium (bromide) in children
    Farmacocinética, farmacodinámica, seguridad y tolerabilidad de bromuro de glicopirronio en niños
    A.4.1Sponsor's protocol code numberCQVM149C2201
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/362/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Farmacéutica, 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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMO)
    B.5.3 Address:
    B.5.3.1Street AddressGran vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34930353036
    B.5.5Fax number+34932479903
    B.5.6E-maileecc.novartis@novartis.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 Yes
    D.2.1.1.1Trade name Seebri Breezhaler
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGlycopyrronium bromide 25 μg of active moiety in the capsule
    D.3.2Product code NVA237
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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 INNGlycopyrronium bromide
    D.3.9.1CAS number 596-51-0
    D.3.9.2Current sponsor codeNVA237
    D.3.9.4EV Substance CodeSUB07951MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 Seebri Breezhaler
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGlycopyrronium bromide 12.5 μg of active moiety in the capsule
    D.3.2Product code NVA237
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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 INNGlycopyrronium bromide
    D.3.9.1CAS number 596-51-0
    D.3.9.2Current sponsor codeNVA237
    D.3.9.4EV Substance CodeSUB07951MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder, hard capsule
    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
    Asthma
    Asma
    E.1.1.1Medical condition in easily understood language
    Asthma
    Asma
    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 PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    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
    Evaluate the change from Baseline in trough forced expiratory volume in one second (FEV1) at week 2 of each treatment period
    Evaluar el cambio respecto al basal en el volumen espiratorio forzado valle en el primer segundo (FEV1) en la semana 2 de cada período de tratamiento.
    E.2.2Secondary objectives of the trial
    - To characterize systemic exposure following 2 doses of glycopyrronium (GLY)
    - To evaluate the change from Baseline in peak expiratory flow (PEF) rate at week 2 of each treatment period
    - To evaluate the change from Baseline in FEV1 at 30 min and 1 hour post dose at week 2 of each treatment period
    - To evaluate the change from Baseline in rescue medication use over each treatment period
    - To evaluate the safety and tolerability of each treatment, including in laboratory parameters including blood glucose and serum potassium
    - To assess typical anti-muscarinic side effects (including dry mouth, fatigue, constipation and urinary retention)
    - Caracterizar la exposición sistémica después de 2 dosis de glicopirronio (GLI).
    - Evaluar el cambio respecto a la basal en la velocidad del flujo espiratorio máximo (FEM) en la semana 2 de cada período de tratamiento.
    - Evaluar el cambio respecto a la basal en el FEV1 30 minutos y 1 hora después de la dosis, en la semana 2 de cada período de tratamiento.
    - Evaluar el cambio respecto al basal en el uso de medicación de rescate durante cada período de tratamiento.
    - Evaluar la seguridad y tolerabilidad de cada tratamiento, incluidos los parámetros de laboratorio como la glucosa en sangre y el potasio sérico.
    - Evaluar los efectos secundarios antimuscarínicos típicos (como boca seca, fatiga, estreñimiento y retención urinaria).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Confirmed diagnosis of asthma for at least 6 months
    - Signed informed consent by parent(s)/legal guardian(s) and assent by the pediatric patient (depending on local requirements)
    - Patient on stable dose of inhaled low-to-medium dose ICS with one additional controller for at least 4 weeks prior to randomization
    - Pre-Bronchodilator FEV1 >/=60% to </=90% of predicted normal at beginning of Run-in and randomization
    - FEV1 reversibility, done using up to 4 puffs of SABA (up to 400μg salbutamol or 360μg albuterol) at Run-in visit (Visit 20): increase >
    and/or = 12% (performed according to American Thoracic Society (ATS)/European Respiratory Society (ERS) 2019 guidelines). All patients
    must perform a reversibility test at start of Run-in. If reversibility is not demonstrated at Run-in, it may be repeated once on the same day. If
    reversibility is still not demonstrated after repeated assessment patients must be screen failed
    - Demonstrated acceptable inhaler use technique for Breezhaler and Diskus/Accuhaler prior to randomization, and able to complete spirometry
    procedures prior to randomization
    - A parent/legal guardian must be designated to complete all e-Diaryentries and attend all clinic visits with the patient
    - Parents/legal guardian must be willing and able to assist the child with the procedures outlined in the protocol, e.g. compliance with study
    medication, completion of electronic patient diary
    - Female patients of child-bearing potential, who might become sexually active, must be informed of the need to prevent pregnancy during the study
    using effective contraceptive methods. The decision on the contraceptive method should be reviewed at least every 3 months to evaluate the
    individual need and compatibility of the method chosen.
    - Diagnóstico documentado confirmado de asma durante al menos 6 meses antes de la selección.
    - Se debe obtener el consentimiento informado firmado de los progenitores/tutores legales y el asentimiento de los pacientes pediátricos (según los requisitos locales)
    -Pacientes que reciban una dosis de baja a media estable de CI (hasta 400 ug diarios de budesónida [IPS] o equivalente) con un controlador adicional durante al menos las 4 semanas anteriores a la aleatorización.
    -FEV1 prebroncodilatador entre >/=60 % y </=90 % del valor teórico normal al inicio de la preinclusión y la aleatorización.
    -Reversibilidad de FEV1, realizada mediante un máximo de 4 inhalaciones de SABA (hasta 400 μg de salbutamol o 360 μg de albuterol) en la visita de preinclusión (visita 20): incremento > o = al 12 % (realizada según las guías de la Sociedad Estadounidense de Medicina Torácica (ATS)/Sociedad Europea de Respiratorio (ERS) de 2019). Todos los pacientes deben someterse a una prueba de reversibilidad al inicio de la preinclusión. Si no se demuestra la reversibilidad en la preinclusión, puede repetirse una vez el mismo día. Si sigue sin poder demostrarse la reversibilidad después de repetir la prueba, los pacientes deben considerarse fallos de selección.
    - Técnica de inhalación aceptable demostrada del Breezhaler y Diskus/Accuhaler antes de la aleatorización y poder completar los procedimientos de espirometría antes de la aleatorización.
    - Debe designarse un progenitor/tutor legal para cumplimentar todas las entradas del diario electrónico y acudir a todas las visitas clínicas con el paciente.
    - Los progenitores/tutor legal deben querer y poder ayudar al niño con los procedimientos descritos en el protocolo, p. ej., con el cumplimiento de la administración de la medicación del estudio y la cumplimentación del diario electrónico del paciente.
    - Se deberá indicar a las pacientes con posibilidad de quedarse embarazadas y de pasar a ser sexualmente activas que deben evitar el embarazo durante el estudio utilizando métodos anticonceptivos eficaces. La decisión sobre el método anticonceptivo se revisará al menos cada 3 meses para evaluar cada necesidad y la compatibilidad del método elegido
    E.4Principal exclusion criteria
    - Systemic corticosteroid use for any reason within 3 months of Run-in
    - Patients on low to medium mono ICS alone-Patients requiring six or more puffs of rescue medication per day on more than two consecutive days in
    the four weeks prior to Screening (Visit 1) and/or in the four weeks prior to the Run-in visit-Patients who have had an asthma attack/exacerbation
    requiring a) systemic corticosteroids (SCS) or b) hospitalization or c) emergency room visit, within 3 months prior to Screening (Visit 1), or more than
    3 separate exacerbations in the 12 months preceding the Screening visit-Patients with a known narrow-angle glaucoma, bladder dysfunction, bladder
    outlet obstruction or any other conditions where anticholinergic treatment is contraindicated prior to Screening (Visit 1)-Patients with a history of
    long QT syndrome or whose corrected QT interval (QTc) measured at start of Run-in and confirmed at Baseline (prior to randomization) (Fridericia
    method) is prolonged (> 450 msec for boys and girls) and confirmed by a central assessor (these patients should not be rescreened)
    - Suspected or documented active infections (bacterial, viral, fungal, mycobacterial or other, including active SARS-CoV-2, tuberculosis or atypical
    mycobacterial disease) of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 6 weeks of Screening (Visit1)
    - History of Type I diabetes or uncontrolled Type II diabetes
    - Patients who are sexually active at screening
    - Hemoglobin levels outside normal ranges at Run-in (Visit 20)
    - Female patients of childbearing potential (e.g., are menstruating) who do not agree to abstinence or, if they become sexually active during study
    participation, do not agree to the use of contraception as defined in the inclusion criteria.
    - Uso de corticosteroides sistémicos por cualquier motivo durante los 3 meses anteriores a la preinclusión
    - Los pacientes que reciban una dosis de baja a media de CI en monoterapia
    - Pacientes que precisen seis o más inhalaciones de medicación de rescate al día durante más de dos días consecutivos en las cuatro semanas anteriores a la selección (visita 1) y/o en las cuatro semanas anteriores a la visita de preinclusión
    - Pacientes que hayan presentado un ataque/exacerbación asmática que precise: a) corticosteroides sistémicos (CS) o b) hospitalización o c) visita a urgencias, durante los tres meses anteriores a la selección (Visita 1) o más de 3 exacerbaciones independientes en los 12 meses anteriores a la visita de selección
    - Pacientes con glaucoma de ángulo estrecho, disfunción vesical, obstrucción de la salida de la vejiga u otra afección conocida para la que el tratamiento anticolinérgico esté contraindicado antes de la selección (Visita 1).
    - Pacientes con antecedentes de síndrome QT prolongado o cuyo intervalo QT corregido (QTc) medido al inicio de la preinclusión y confirmado en la basal (antes de la aleatorización) (método de Fridericia) sea prolongado (>450 ms para niños y niñas) y que esté confirmado por un asesor central (estos pacientes no volverán a ser seleccionados).
    - Infecciones activas documentadas o sospecha de ello (bacterianas, víricas, fúngicas, micobacterianas u otras, como SARS-CoV-2 activo, tuberculosis o enfermedad micobacteriana atípica) del tracto respiratorio superior o inferior, senos paranasales u oído medio que no remita durante las 6 semanas anteriores a la selección (Visita 1).
    - Antecedentes de diabetes tipo I o diabetes tipo II no controlada.
    - Pacientes sexualmente activos en la selección.
    - Niveles de hemoglobina fuera del rango normal en la preinclusión (Visita 20)
    - Pacientes con posibilidad de quedarse embarazadas (p.ej. menstruantes) las cuales no estén de acuerdo con la abstinencia o si resultan sexualmente activas durante la participación del estudio, no estén de acuerdo en usar métodos de contracepción tal y como se definen en el criterio de inclusión.
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline in trough FEV1 at week 2 of each treatment period.
    Cambio respecto a la basal en el FEV1 en la semana 2 de cada período de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 2
    Semana 2
    E.5.2Secondary end point(s)
    - Steady state PK parameters C0 will be provided for plasma glycopyrronium concentrations at pre-dose and post-dose time-points at the start and end of each 2 week treatment period. Systemic exposure following sparse PK sampling will be provided at pre-dose and post-dose time-points for each glycopyrronium dose level at the start and end of each 2 week treatment period.
    - Change from baseline in Morning and Evening PEF will be measured at the start and end of each 2 week treatment period.
    - Change from baseline in FEV1 will be measured at the start and end of each 2 week treatment period.
    - Change from baseline in rescue medication use will be recorded each morning and evening throughout the 2 week treatment by the participant using their electronic diary.
    - AESIs that are typical of anti-muscarinic agents will be assessed from the start of run-in to 30 days after end of treatment, up to maximum duration of 16 weeks.
    - Se proporcionarán los parámetros PK de C0 en estado de equilibrio de las concentraciones de glicopirronio en plasma en los momentos anteriores y posteriores a la dosis al inicio y al final de cada periodo de tratamiento de 2 semanas. Se proporcionará la exposición sistémica después de la recogida de escasas muestras para PK en los momentos anteriores y posteriores a la dosis en cada nivel de dosis de glicopirronio al inicio y al final de cada periodo de tratamiento de 2 semanas.
    - Se medirá el cambio respecto a la basal del PEF matutino y nocturno al inicio y al final de cada periodo de tratamiento de 2 semanas.
    - Se medirá el cambio respecto a la basal del FEV1 al inicio y al final de cada periodo de tratamiento de 2 semanas.
    - El participante registrará el cambio respecto a la basal del uso de la medicación de rescate cada mañana y noche durante las 2 semanas de tratamiento en el diario electrónico.
    - Se evaluarán los AAEI típicos de los fármacos antimuscarínicos desde el inicio de la preinclusión hasta 30 días después del fin de tratamiento, una duración máxima de 16 semanas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 2
    Semana 2
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Colombia
    Guatemala
    Russian Federation
    South Africa
    Hungary
    Poland
    United Kingdom
    Bulgaria
    Spain
    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
    LVLS
    Última visita del último paciente (LVLP)
    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 months6
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 42
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 42
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 42
    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)
    Once the participant has completed the end of study visit or early termination study, the participant will stop taking the background and investigational treatment. The investigator will assign the patient to the best available asthma maintenance treatment
    Cuando el participante haya completado la visita de fin de estudio o haya interrumpido prematuramente el estudio, dejará de tomar el tratamiento de base y el tratamiento en investigación. El investigador asignará al paciente el mejor tratamiento de mantenimiento para el asma disponible
    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 Decision2022-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-25
    P. End of Trial
    P.End of Trial StatusOngoing
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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
    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.

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