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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   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:2008-001284-11
    Sponsor's Protocol Code Number:SSH-FQ1
    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:2009-01-27
    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 number2008-001284-11
    A.3Full title of the trial
    Estudio de la eficacia del tratamiento a largo plazo con suero salino hipertónico sobre las exacerbaciones pulmonares en pacientes con Fibrosis Quística
    A.4.1Sponsor's protocol code numberSSH-FQ1
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorADELAIDA LAMAS FERREIRO
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 CLORURO SODICO 7%
    D.2.1.1.2Name of the Marketing Authorisation holderLA BOTICA DE ARGENSOLA
    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 nameCLORURO SODICO 7%
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNCLORURO SODICO 7%
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 to 12H
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 CLORURO SODICO 7%
    D.2.1.1.2Name of the Marketing Authorisation holderLA BOTICA DE ARGENSOLA
    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 nameCLORURO SODICO 7%
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNCLORURO SODICO 7%
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 to 12H
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Fibrosis Quística
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar si la inhalación de mayor volumen (10 ml) de SSH al 7% dos veces al día y a largo plazo, disminuye en mayor cuantía el número de exacerbaciones pulmonares en pacientes con Fibrosis Quística con respecto a la disminución ya demostrada de las mismas cuando se ha empleado este fármaco a volumen convencional (4-5 ml cada 12 horas).
    E.2.2Secondary objectives of the trial
    Estudiar si la inhalación de un mayor volumen de SSH produce modificaciones en la función pulmonar, una disminución en el empleo de antibióticos orales e intravenosos, en los parámetros inflamatorios tanto a nivel pulmonar como sistémico, modificaciones en la bacteriología del esputo.
    Estudiar la relación entre la disminución de las exacerbaciones pulmonares, secundarias a la inhalación de un mayor volumen de SSH, con la edad y la función pulmonar previa del paciente.
    Estudiar si las modificaciones en los parámetros inflamatorios están relacionadas con la función pulmonar previa del paciente y con su edad.
    Estudiar la adherencia al tratamiento, tolerabilidad y eficacia de la inhalación de SSH en un dispositivo de alto flujo de rápida nebulización.
    Estudiar si la técnica de esputo inducido aumenta la rentabilidad de los estudios microbiológicos.
    Estudiar las modificaciones que sobre la calidad de vida tiene la inhalación de SSH a largo plazo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pacientes en seguimiento y tratamiento en la Unidad de Fibrosis Quística del Hospital Ramón y Cajal y en la Sección de Neumología Pediátrica del Hospital Infantil La Paz, que tras haber recibido información sobre el diseño, los fines del estudio, los posibles riesgos que de él pueden derivarse y sabiendo que en cualquier momento pueden denegar su colaboración, otorguen por escrito su consentimiento para participar en el estudio y que cumplan los siguientes criterios:

    Diagnóstico de Fibrosis Quística de acuerdo a los criterios publicados en el documento de consenso en 1998 55 que requiere, una o más de las características fenotípicas típicas de la enfermedad o hermanos afectos o despistaje positivo en el periodo neonatal asociado a más dos pruebas de sudor con ión cloruro ≥ 60 mEq/L o detección de dos mutaciones conocidas del gen de la FQ o demostración in vivo de las alteraciones del transporte iónico a través del epitelio nasal.
    Edad mayor de 6 años.
    Capacidad para la realización de una espirometría con valores reproducibles de acuerdo a los estándares publicados para niños por la Sociedad Española de Neumología pediátrica56 y en adultos de acuerdo a los estándares publicados por la Sociedad Española de Neumología y Cirugía Torácica (SEPAR) (Sanchis Alda J, Sasan Clara P, Castillo Gómez J, González Mangado N, Palenciano Ballesteros, Roca Torrent J. Grupo de trabajo de la SEPAR para la práctica de la espirometría en clínica. Recomendaciones SEPAR. Normativa para la práctica de la espirometría forzada. Arch Bronconeumol 1989; 25: 132-142).
    Valor de flujo espiratorio forzado en el primer segundo (FEV1) con respecto al teórico para su edad, sexo, peso y talla superior al 30%.
    Capacidad de realización de la técnica de esputo inducido de acuerdo a lo explicado en el Anexo III del protocolo
    Radiografía de tórax inicial sin hallazgos significativos de carácter agudo (infiltrados, neumotórax o derrame pleural)
    Tolerancia clínica a la inhalación de 10 ml suero salino hipertónico de acuerdo a lo explicado en el Apartado 8 del protocolo
    Situación clínica estable, sin presencia de exacerbación pulmonar durante las 4 semanas previas a su inclusión en el estudio de acuerdo a los criterios explicados en el Apartado 7.1.
    Pacientes sin tratamiento con suero salino hipertónico en las 4 semanas previas a la inclusión en el estudio.
    Pacientes sin tratamiento antibiótico durante las 4 semanas previas a su inclusión en el estudio.
    Consentimiento informado por escrito para la participación en el ensayo clínico firmado por padre o madre o tutor legal del paciente en el caso de ser menor de edad o por el enfermo en el caso de ser mayor de edad.
    E.4Principal exclusion criteria
    · Pacientes no diagnosticados de Fibrosis Quística
    · Pacientes que no acepten participar en el estudio
    · Intolerancia a la inhalación de 10 ml de suero salino hipertónico de acuerdo a lo explicado en el Apartado 8 (Acontecimientos adversos) comprobar
    · Test de embarazo positivo
    · Incapacidad para la tolerancia de β2-agonistas
    · Pacientes en tratamiento con corticoides orales
    · FEV1 < 30% con respecto al valor teórico de acuerdo a su edad, talla, peso y sexo.
    · Pacientes en lista de espera para transplante de órgano sólido (pulmón – hígado)
    · Pacientes sometidos a transplante hepático o pulmonar.
    · Pacientes dependientes de oxígeno
    · Ingreso hospitalario en las 4 semanas previas al inicio del estudio
    · Administración de antibióticos orales o intravenosos en las 4 semanas previas al inicio del estudio
    · Cambios en el tratamiento habitual en las 4 semanas previas al inicio del estudio
    · Pacientes fumadores
    · Pacientes colonizados por Burkholderia cepacia

    E.5 End points
    E.5.1Primary end point(s)
    Número de exacerbaciones pulmonares de acuerdo a los criterios de Fuschs modificados que se definen de la siguiente forma:
    Se considera exacerbación clínica la necesidad de administración de antibióticos orales o intravenosos de acuerdo a la presencia de al menos 4 de los siguientes signos o síntomas:
    - Aumento de la expectoración
    - Aumento de la purulencia del esputo
    - Aparición o aumento de la hemoptisis
    - Aumento de la tos
    - Aumento de la disnea
    - Fiebre (T ª ³ 38ºC)
    - Reducción de la función pulmonar (> 10% del FEV1 o FVC sobre el basal)
    - Aparición de nuevos infiltrados en Rx de tórax
    - Cambios en los ruidos respiratorios valorados por auscultación
    - Disminución de peso o anorexia
    - Aumento de la secreción purulenta a través de los senos paranasales

    Cuando la magnitud de los anteriores efectos sea elevada, o en caso de no respuesta al tratamiento ensayado y el paciente requiera ingreso hospitalario, se considerará una exacerbación pulmonar con ingreso hospitalario.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 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 Information not present in EudraCT
    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
    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 days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    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 state120
    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 Decision2009-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-02
    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
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