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    Summary
    EudraCT Number:2016-004033-25
    Sponsor's Protocol Code Number:PED-FQ-2016
    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:2017-03-31
    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 number2016-004033-25
    A.3Full title of the trial
    Efect of nebulized bicarbonate on bacterial infections in patients with cystic fibrosis. Randomized clinical trial
    Efecto del bicarbonato nebulizado en vía aérea sobre las infecciones bacterianas en pacientes con fibrosis quística. Ensayo clínico aleatorizado.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized clinical trial to assess the effect of nebulizad bicarbonate on bacterial infections in patients with cystic fibrosis
    Ensayo clínico aleatorizado para evaluar el efecto del bicarbonato nebulizado sobre las infecciones bacterianas en pacientes con fibrosis quística
    A.4.1Sponsor's protocol code numberPED-FQ-2016
    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 SponsorFundació Parc Taulí
    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 supportFundació Parc Taulí
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitari Parc Tauli
    B.5.2Functional name of contact pointOficina de Recerca
    B.5.3 Address:
    B.5.3.1Street AddressParc Taulí, 1
    B.5.3.2Town/ citySabadell
    B.5.3.3Post code08208
    B.5.3.4CountrySpain
    B.5.4Telephone number34937458451
    B.5.5Fax number34937175067
    B.5.6E-mailafarre@tauli.cat
    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.2.1.2Country 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 nameSodium bicarbonate
    D.3.4Pharmaceutical form Solution for injection
    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 INNSodium Bicarbonate
    D.3.9.1CAS number 144-55-8
    D.3.9.3Other descriptive nameSODIUM BICARBONATE BP
    D.3.9.4EV Substance CodeSUB169196
    D.3.10 Strength
    D.3.10.1Concentration unit mol/l mole(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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.2.1.2Country 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 namesodium chloride
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNSodium chloride
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/ml gram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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: 3
    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.3.1Product namesodium chloride
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNSodium chloride
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/ml gram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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: 4
    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.3.1Product nameWater for injections
    D.3.4Pharmaceutical form Solvent for parenteral use
    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 INNwater for injections
    D.3.9.1CAS number 7789-20-0
    D.3.9.3Other descriptive nameWATER FOR INJECTIONS, EP
    D.3.9.4EV Substance CodeSUB45376
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboSolution for injection
    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
    Cystic Fibrosis
    Fibrosis Quística
    E.1.1.1Medical condition in easily understood language
    Cystic Fibrosis
    Fibrosis Quística
    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 10074550
    E.1.2Term Preventive antimicrobial therapy in cystic fibrosis
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10011764
    E.1.2Term Cystic fibrosis NOS
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of nebulized bicarbonate on bacterial infections in the airway of patients with CF diagnosis.
    Valorar el efecto del bicarbonato nebulizado sobre las infecciones bacterianas en la vía aérea, de pacientes con diagnóstico de FQ.
    E.2.2Secondary objectives of the trial
    - Analyze the pH variation of the airway after nebulized bicarbonate therapy.
    - To evaluate the cellular inflammatory changes that occur in the sputum, after nebulization with bicarbonate.
    - To compare the effect on bronchial obstruction of nebulized bicarbonate in the airway versus hypertonic saline solution 7% using the Leicester Cuestionario.
    - To compare the number of patients chronified at the end of the study, in both groups.
    - To compare the quality of life of patients in groups A and B.
    - Assess adherence to treatment by controlling the dispensing and the Morinsky-Green test.
    - Analyze possible adverse reactions.
    - Analizar la variación de pH de la vía aérea tras la terapia con bicarbonato nebulizado.
    - Valorar los cambios inflamatorios celulares que se producen en el esputo, tras la nebulización con bicarbonato.
    - Comparar el efecto sobre la obstrucción bronquial del bicarbonato nebulizado en la vía aérea versus el suero salino hipertónico 7% mediante el Cuestionario tos Leicester .
    - Comparar el número de pacientes cronificados al final del estudio, en ambos grupos.
    - Comparar la calidad de vida de los pacientes de los grupos A y B.
    - Valorar la adherencia al tratamiento mediante el control de la dispensación y el test de Morinsky-Green.
    - Analizar las posibles reacciones adversas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients of both genders with CF diagnosis.
    - FEV1> 40%.
    - Age over 6 years.
    - Patients with sputum culture negative for Pseudomonas
    - Patients who give their informed consent or whose representative gives informed consent to participate in the study.
    - Pacientes de ambos géneros con diagnóstico de FQ.
    - FEV1 >40%.
    - Edad mayor de 6 años.
    - Pacientes con cultivo de esputo negativo para Pseudomonas
    - Pacientes que otorguen su consentimiento informado o cuyo representante otorgue el consentimiento informado a participar en el estudio.
    E.4Principal exclusion criteria
    - Pregnant or lactating women
    - Women of childbearing potential, not using valid contraceptive methods:
    - Abstinence
    - Surgical sterilization
    - Male partner sterilization
    - Barrier contraceptive methods
    - Hormonal contraceptive methods or other with similar efficacy
    - Baseline oxygen saturation <92% or supplementary oxygen needs at home.
    - Masive Hemoptysis
    - Patients colonized by pseudomonas
    - Patients who are not able to follow study assessments according to protocol
    - Any circumstance that at the discretion of the physician may pose a risk or clinical harm to the patient's participation in the study or interfere with the assessments of the same.
    - Mujeres embarazadas o en período de lactancia
    - Mujeres en edad fértil, definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas, salvo que estén utilizando métodos básicos de anticoncepción durante la administración del fármaco en investigación. Los métodos anticonceptivos básicos incluyen:
    o Abstinencia total (cuando esté en consonancia con el estilo de vida habitual y preferido del paciente). La abstinencia periódica (p. ej., calendario, ovulación, métodos sintotérmicos, postovulación) y el coitus interruptus no son métodos anticonceptivos aceptables.
    o Esterilización de la mujer (ha sido sometida a ooforectomía bilateral quirúrgica con o sin histerectomía), histerectomía total o ligadura de trompas al menos seis semanas antes de tomar el fármaco en investigación. Si sólo se ha realizado ooforectomía, sólo cuando se ha confirmado el estado reproductivo de la mujer mediante el seguimiento de la evaluación del nivel hormonal.
    o Esterilización del varón (al menos 6 meses antes de la selección). Para las pacientes mujeres participantes en el estudio, la pareja varón vasectomizado debería ser la única pareja de dicha paciente.
    o Métodos anticonceptivos de barrera: preservativo o tapón oclusivo (diafragma o capuchón en bóveda/cervical). Para RU: con un gel/ espuma/ película/ crema/ supositorio vaginal espermicida.
    o Uso de métodos anticonceptivos hormonales orales, (estrógenos y progesterona), inyectados o implantados u otras formas de anticoncepción hormonal que tengan eficacia comparable (tasa de fallo <1%); por ejemplo, anillo hormonal vaginal o anticoncepción hormonal transdérmica o colocación de un dispositivo intrauterino (DIU) o sistema intrauterino (SIU).
    En caso de utilizar anticonceptivos orales, las mujeres deberán haber utilizado de forma estable la misma píldora durante un mínimo de 3 meses antes de tomar el fármaco en investigación.
    - Se considera que una mujer es posmenopáusica y no fértil si lleva 12 meses de amenorrea natural (espontánea) con un perfil clínico apropiado (p. ej., edad apropiada, antecedentes de síntomas vasomotores) o si ha sido sometida a ooforectomía bilateral quirúrgica (con o sin histerectomía), histerectomía total o ligadura de trompas al menos seis semanas antes. Si sólo se ha realizado ooforectomía, se considerará que una mujer no es fértil sólo cuando se haya confirmado el estado reproductivo de la mujer mediante el seguimiento de la evaluación del nivel hormonal.
    - Saturación basal de oxígeno <92% o necesidades de oxígeno suplementario domiciliario.
    - Hemoptisis masiva
    - Pacientes colonizados por pseudomonas
    - Pacientes que no sean capaces de seguir las valoraciones del estudio según el protocolo
    - Cualquier circunstancia que a criterio del médico le pueda suponer un riesgo o perjuicio clínico la participación del paciente en el estudio ó que interfiera en las valoraciones del mismo.
    E.5 End points
    E.5.1Primary end point(s)
    Number of sputum cultures positive to Pseudomonas, taken at each follow-up visit during the year of study.
    Número de cultivos de esputo positivos a Pseudomonas, tomado en cada visita de seguimiento durante el año de estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 8 weeks during 52 weeks
    Cada 8 semanas durante 52 semanas
    E.5.2Secondary end point(s)
    - Number of sputum cultures positive for staphylococcus and other bacteria, mycobacteria and fungi, taken at each follow-up visit during the year of study.
    - Time between the start of the study and the first culture of positive sputum.
    - Changes in the pH of the airway fluid measured in the induced sputum in each visit compared to baseline
    - Changes in the quality of life test score in each visit compared to baseline
    - Changes from baseline in total lung volume by plethysmography at 12 months of treatment
    - Changes in the cellularity of the induced sputum in each of the visits
    - Leicester Cough Questionnaire on each visit
    - Adverse reactions
    - Morinsky adhesion test
    - Number of exacerbations per patient at end of study
    - Evolution with respect to baseline in FEV1 by spirometry in each of the study visits
    - Vitamin A, D, E levels, prothrombin time and thromboplastin time
    - Sobel test at 12 months of treatment
    - Radiological changes in the pulmonary parenchyma by pulmonary CT of low irradiation at 12 months of treatment
    Número de cultivos de esputo positivos a staphilococos y otras bacterias, micobacterias y hongos, tomado en cada visita de seguimiento durante el año de estudio.
    - Tiempo entre el inicio del estudio y el primer cultivo de esputo positivo.
    - Cambios en el pH del líquido periciliar medido en el esputo inducido en cada una de las visitas respecto del valor basal
    - Cambios en la puntuación del Test de calidad de vida en cada una de las visitas con respecto al valor basal
    - Cambios con respecto de la basal en el volumen pulmonar total por pletismografia a los 12 meses de tratamiento
    - Cambios en la celularidad del esputo inducido en cada una de las visitas
    - Cuestionario de Tos de Leicester en cada una de las visitas
    Reacciones adversas
    - Test de adherencia de Morinsky
    - Número de exacerbaciones por paciente al final del estudio
    - Evolución con respecto de la basal en el FEV1 por espirometría en cada una de las visitas del estudio
    - Niveles de vitaminas A,D,E, tiempo de protrombina y tiempo de tromboplastina
    - Test de sobel a los 12 meses de tratamiento
    - Cambios radiológicos en el parenquima pulmonar mediante TAC pulmonar de baja irradiación a los 12 meses de tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 2 months during 52 weeks
    Cada 2 meses durante 52 semanas
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 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 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
    Last subject last visit
    último paciente última visita
    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 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 Yes
    F.1.1Number of subjects for this age range: 50
    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: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    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
    Subjects under age of 18
    Sujetos menores de 18 años
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    patients with incurable disease
    Paciente con enfermedad incurable
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    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)
    If it is favorable to use nebulized bicarbonate to prevent respiratory infections in patients with Cystic Fibrosis, it will later be included in the usual therapy after the aproval of the therapeutic institutional committee
    Si resulta favorable el uso del bicarbonato nebulizado para prevenir las infecciones respiratorias en los pacientes con Fibrosis Quística, posteriormente se incluirá en la terapéutica habitual, previa aprobación del Comité terapéutico institucional
    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 Decision2017-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-11
    P. End of Trial
    P.End of Trial StatusOngoing
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