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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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:2006-001417-16
    Sponsor's Protocol Code Number:SFA106484
    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:2012-06-08
    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 number2006-001417-16
    A.3Full title of the trial
    Estudio doble-ciego, doble enmascaramiento, con asignación aleatoria a los grupos de tratamiento y con grupos paralelos, que evalúa la seguridad de la combinación salmeterol/propionato de fluticasona (Seretide), administrando dos inhalaciones de 25/50 mcg dos veces al día, con propionato de fluticasona (Flixotide), administrando dos inhalaciones de 50 mcg dos veces al día, ambos administrados mediante cartucho presurizado con hidrofluoroalcanos, durante 12 semanas en niños asmáticos de 4 a 11 años de edad.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Estudio doble-ciego, doble enmascaramiento, con asignación aleatoria a los grupos de tratamiento y con grupos paralelos, que evalúa la seguridad de la combinación salmeterol/propionato de fluticasona (Seretide), administrando dos inhalaciones de 25/50 mcg dos veces al día, con propionato de fluticasona (Flixotide), administrando dos inhalaciones de 50 mcg dos veces al día, ambos administrados mediante ......
    A.4.1Sponsor's protocol code numberSFA106484
    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 SponsorGlaxoSmithKline 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 supportGlaxoSmithKline, S.A.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointGSK Clinical Support Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Birdge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number442089904466
    B.5.5Fax number442089904968
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameFluticasone propionate/salmeterol HFA
    D.3.2Product code CCI18781 + GR33343G + GR106642X
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNsalmeterol xinafoate
    D.3.9.1CAS number 94749-08-3
    D.3.9.2Current sponsor codeGR33343G
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.3.9.2Current sponsor codeCCI18781
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.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 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 nameFluticasone Propionate HFA
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNfluticasone propionate
    D.3.9.1CAS number 80474-14-2
    D.3.9.2Current sponsor codeCCI18781
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboPressurised inhalation, suspension
    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
    Asma
    E.1.1.1Medical condition in easily understood language
    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 14.1
    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
    El objetivo principal del estudio es evaluar la seguridad de 100/50mcg de propionato de fluticasona /salmeterol dos veces al día en comparación con con 100 mcg de fluticasona dos veces al día en pacientes de 4 a 11 años de edad con asma persistente
    E.2.2Secondary objectives of the trial
    El objetivo principal del estudio es evaluar la seguridad de 100/50mcg de propionato de fluticasona /salmeterol dos veces al día en comparación con con 100 mcg de fluticasona dos veces al día en pacientes de 4 a 11 años de edad con asma persistente
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Estudio doble-ciego, doble simulado, con asignación aleatoria a los grupos de tratamiento y con grupos paralelos, que evalúa la seguridad de la combinación salmeterol/propionato de fluticasona (Seretide), administrando dos inhalaciones de 25/50 mcg dos veces al día, con propionato de fluticasona (Flixotide), administrando dos inhalaciones de 50 mcg dos veces al día, ambos administrados mediante cartucho presurizado con hidrofluoroalcanos, durante 12 semanas en niños asmáticos de 4 a 11 años de edad.
    fecha 12 de dciiembre de 2006, versión 1.0

    OBJETIVOS: El objetivo de la investigación FGx (si hay una posible variación inesperada o inexplicada) es estudiar una posible relación genética para el manejo o respuesta al propionato de fluticasona/salmeterol y al propionato de fluticasona. Si en algún momento pareciera que hay una variación potencial en la respuesta en este ensayo clínico o en una serie de ensayos clínicos con propionato de fluticasona/salmeterol y propionato de fluticasona que se pudiera atribuir a variaciones genéticas de los pacientes, se podrán investigar los siguientes objetivos:
    ? Relación entre las variantes genéticas y la farmacocinética del producto en investigación.
    ? Relación entre las variantes genéticas y la seguridad o tolerabilidad del producto en investigación.
    ? Relación entre las variantes genéticas y la eficacia del producto en investigación.
    En tales circunstancias, el análisis que se lleve a cabos se limitará al análisis FGx del manejo o respuesta de propionato de fluticasona 100/50 y puede incluir la evaluación de genes candidato específicos, la búsqueda de polimorfismo nucleótido simple (SNP) en todo el genoma o la búsqueda de otro marcador.
    Para el enfoque de la búsqueda de SNP, se investigarán secuencias SNP o de otros marcadores genéticos para identificar qué marcadores se asocian con las diferencias en el manejo o la respuesta al fármaco.
    E.3Principal inclusion criteria
    El paciente deberá poder ser tratado en régimen ambulatorio.
    En la visita 1 el paciente deberá tener entre 4 y 11 años de edad.
    Hombre o mujer en la pre-menarquia.
    El paciente presentará diagnóstico de asma que haya requerido terapia farmacológica prescrita por un facultativo durante al menos los 2 meses previos a la visita 1.
    En la visita 1 tras interrumpir las medicaciones para el asma, los pacientes de 6 a 11 años de edad deberán demostrar que el mejor VEMS matutino basal previo a la toma de albuterol (salbutamol) en consulta es mayor o igual al 60% del valor teórico Polgar y los pacientes de 4 y 5 años de edad deberán demostrar que el mejor FEM matutino basal previo a la toma de albuterol (salbutamol) en consulta es ? 60% del valor teórico Polgar .
    El paciente deberá presentar historia documentada de incremento mayor o igual a 12% en el VEMS o FEM durante los 30 minutos siguientes a la administración de albuterol (salbutamol) (MDI o nebulizado) o levalbuterol durante los 24 meses anteriores a la visita 1 o, en la actualidad, patología reversible de las vías aéreas que se demuestre en la visita 1 por un incremento mayor o igual al 12% del VEMS en los 30 minutos siguientes a la inhalación de 2 a 4 pulsaciones (180-360mcg) o de un tratamiento nebulizado de albuterol (salbutamol), en relación al VEMS (6 a 11 años) o FEM (4 y 5 años) previos a la administración de albuterol (salbutamol) inhalado en aerosol.
    Los pacientes son elegibles para participar en el estudio si han estado utilizando un corticoide inhalado en dosis constantes, dentro de un intervalo de dosis constante, durante al menos el mes previo a la visita 1
    E.4Principal exclusion criteria
    El paciente no debe presentar asma que suponga un riesgo para la salud. En este protocolo se considera asma de riesgo para la salud a los antecedentes de episodio/s de asma significativa que haya/n requerido intubación, asociados con hipercapnia, parada respiratoria o convulsiones hipóxicas, o episodios sincopales debidos al asma. El paciente no tiene que haber sido hospitalizado dos o más veces en el último año a causa del asma.
    Las medicaciones para el asma que se enumeran en el protocolo no tienen que haber sido utilizadas
    antes de la visita 1 durante el intervalo de tiempo requerido que aquí se indica y no deben utilizarse durante el estudio.

    Terapia con corticosteroides: Durante el estudio está prohibido el uso de cualquier otro tratamiento corticosteroide que no sea la medicación de estudio, de corticosteroides intranasales y de cremas o ungüentos que contengan hidrocortisona tópica (mnor o igual al 1%) de baja potencia.
    E.5 End points
    E.5.1Primary end point(s)
    Las medidas de seguridad en este estudio incluyen las siguientes:
    evaluación de los acontecimientos adversos
    ECG de 12 derivaciones
    pruebas de laboratorio (hematología/bioquímica)
    excreción de cortisol en orina de 24-horas
    presión arterial
    resultados de la exploración orofaríngea
    exacerbaciones asmáticas
    porcentaje de pacientes que abandonan debido al empeoramiento del asma.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Information is no present in EudraCT
    E.5.2Secondary end point(s)
    Information is no present in EudraCT
    E.5.2.1Timepoint(s) of evaluation of this end point
    Information is no present in EudraCT
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    doble simulado
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Canada
    Chile
    Costa Rica
    Germany
    Latvia
    Lithuania
    Mexico
    Peru
    Poland
    Russian Federation
    Spain
    United States
    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
    llamada telefónica a los 5 + 2 días después de la visita 7 / discontinuación para valorar efectos adverseosposteriors al tratamiento
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    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: 300
    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: 300
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    paediatrics
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 300
    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)
    Information is no present in EudraCT
    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 Decision2007-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-01-28
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