Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   38197   clinical trials with a EudraCT protocol, of which   6274   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-001565-33
    Sponsor's Protocol Code Number:CTBM100C2403
    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:2013-05-16
    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 number2012-001565-33
    A.3Full title of the trial
    An open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis
    Estudio de Fase IV, abierto, cruzado, de intervención para comparar la facilidad de uso de tobramicina polvo para inhalación frente a tobramicina solución para inhalación y colistimetato nebulizado para el tratamiento de la infección pulmonar por Pseudomonas aeruginosa pulmonar en pacientes con fibrosis quística
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistin
    Ensayo clínico abierto para comparar cuanto tarda en total un paciente con fibrosis quística en tomar la dosis diaria de tobramicina polvo frente a tobramicina y colistimetato nebulizados
    A.4.1Sponsor's protocol code numberCTBM100C2403
    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 SponsorNovartis Farmaceutica, 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 Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartamento Medico
    B.5.2Functional name of contact pointICRO
    B.5.3 Address:
    B.5.3.1Street AddressGran Via Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number0034900353036
    B.5.5Fax number0034932479903
    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 TOBI Podhaler
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/03/140
    D.3 Description of the IMP
    D.3.1Product nameTOBI Podhaler
    D.3.2Product code TBM100C
    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 INNTobramycin
    D.3.9.1CAS number 32986-56-4
    D.3.9.2Current sponsor codeTBM100
    D.3.9.3Other descriptive nameTOBRAMYCIN
    D.3.9.4EV Substance CodeSUB11134MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number28
    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 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 TOBI 300 mg/5 ml solución para inhalación por nebulizador
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Farmacéutica, S.A.
    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 Nebulisation solution
    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 INNTobramycin
    D.3.9.1CAS number 3232986-56-4
    D.3.9.2Current sponsor codeTBM100
    D.3.9.3Other descriptive nameTOBRAMYCIN
    D.3.9.4EV Substance CodeSUB11134MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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.2.1.1.1Trade name Promixin,1 millón de Unidades Internacionales,polvo para solución para inhalación por nebulizador
    D.2.1.1.2Name of the Marketing Authorisation holderProfile Pharma Limited
    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 Powder and solvent for nebuliser solution
    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 INNColistimethate
    D.3.9.1CAS number 30387-39-4
    D.3.9.3Other descriptive nameCOLISTIMETHATE
    D.3.9.4EV Substance CodeSUB23213
    D.3.10 Strength
    D.3.10.1Concentration unit million IU million international units
    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.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
    Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis
    patients
    Infeccion crónica por Pseudomonas aeruginosa en pacientes con fibrosis quística
    E.1.1.1Medical condition in easily understood language
    Bacterial infection in cystic fibrosis patients
    Infeccion bacteriana en pacientes con fibrosis quística
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10021860
    E.1.2Term Infection pseudomonas aeruginosa
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the mean cumulative time required to prepare the drug, set-up the delivery device, administer the drug, and clean the delivery device using TIP administered with the T 326 Inhaler with the cumulative time to use the patient?s usual (pre-study prescribed) nebulized, antibiotic treatment for P. aeruginosa, as a primary indicator of ease of use.
    Comparar el tiempo medio acumulado necesario para preparar la medicación, para la puesta a punto del dispositivo dosificador, administrar la medicación, y limpiar el dispositivo dosificador utilizando TIP administrado con el DPI T-326 con el tiempo medio acumulado para utilizar el tratamiento antibiótico nebulizado habitual (prescrito antes del estudio) del paciente para P. aeruginosa, como indicador principal de la facilidad de uso.
    E.2.2Secondary objectives of the trial
    To assess:
    -the absolute change in the number of P.aeruginosa colony-forming units in sputum after up to a period of 28days of treatment in each treatment arm
    -the frequency and type of microbial contamination of the T-326 Inhaler used to administer TIP after lifetime use(7days of treatment) compared with the contamination of the nebulizer used for the patient?s usual nebulized antibiotic treatment for P.aeruginosa at baseline(Visit2) and at the completion of each treatment cycle
    -the overall tolerability and safety of TIPvsTISvscolistimethate over both the on-treatment and off-treatment periods of the study by comparison of adverse event rates, severity, and discontinuation rates
    To evaluate:
    -the change in the minimum inhibitory concentration of the relevant antibiotic for P. aeruginosa after a period of up to 28days of treatment of TIPvsTISvscolistimethate
    -the safety profile of TIPvsTISvscolistimethate in terms of clinical laboratory results and postinhalational bronchospasm
    ? Evaluar el cambio absoluto en el número de unidades formadoras de colonias (UFC) de P. aeruginosa en el esputo después de un período de hasta 28 días de tratamiento en cada brazo de tratamiento
    ? Evaluar la frecuencia y el tipo de contaminación microbiana del DPI T-326 utilizado para administrar TIP después del uso durante la vida útil (7 días de tratamiento) en comparación con la contaminación del nebulizador utilizado para el tratamiento antibiótico nebulizado habitual del paciente para P. aeruginosa en la visita basal (Visita 2) y en la finalización de cada ciclo de tratamiento
    ? Evaluar la tolerabilidad global y la seguridad de TIP vs TIS y de TIP vs colistimetato tanto durante los períodos con tratamiento como sin tratamiento del estudio comparando las tasas de acontecimientos adversos (AA), severidad, y retirada
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    * Provide written informed consent, HIPAA authorization, and assent (as appropriate for minors) prior to the performance of any study-related procedure

    * Confirmed diagnosis of CF

    *Male and female patients 6 years of age or older at screening

    *FEV1 at screening (Visit 1) must be at least 25% and less than or equal to 90% of normal predicted values for age, sex, and height based on the NHANES III values (Hankinson, 1999) for patients 18 years of age or greater, and based on values from Wang (Wang 1993) for patients less than 18 years of age.

    *Documented use of any of the nebulized antibiotics based on local practice:
    ?TIS, colistimethate, or TIP for at least 1 cycle within the last 6 months or
    ?colistimethate continuous use for at least 8 weeks within the last 6 months This cycle of treatment (or continuous colisthimethate treatment period) is in addition to the treatment cycle during which the subject is being screened.

    *P. aeruginosa must be present in a sputum or deep cough throat swab culture or bronchoalveolar lavage (BAL) (only for BAL a threshold level of 103 CFU/mL is required) within 6 months prior to screening, and in the sputum or deep cough throat swab culture at screening or rescreening (Visit 1)
    1. Proporcionar el consentimiento informado por escrito, autorización HIPAA (Ley de Responsabilidad y Portabilidad del Seguro Médico) (cuando proceda), y asentimiento (según corresponda) antes de realizar ningún procedimiento relacionado con el estudio.
    2. Diagnóstico confirmado de FQ mediante una o más de las siguientes pruebas para la detección de FQ (actual o antecedentes):
    ? prueba cuantitativa de cloruro en sudor mediante iontofóresis con pilocarpina superior a 60 mmol/L o 60 mEq/L
    ? genotipo con 2 mutaciones identificables que causen FQ
    ? un resultado positivo en la prueba de detección de FQ en el recién nacido
    ? una diferencia anormal en el potencial nasal transepitelial característica de la FQ
    3. Pacientes hombres y mujeres de 6 años de edad o mayores en la selección (Visita 1)
    4. El FEV1 en la selección (Visita 1) debe ser de al menos un 25% y menor o igual al 90% de los valores normales previstos para edad, sexo, y altura en base a los valores de la NHANES III (Hankinson et al 1999) para pacientes de 18 años de edad o mayores, y en base a los valores de Wang (Wang et al 1993) para pacientes menores de 18 años de edad. Para consultar las ecuaciones correspondientes, véase el Apéndice 4.
    5. Uso documentado de cualquier antibiótico nebulizado para tratar la infección crónica por P. aeruginosa en base a la práctica local:
    ? TIS, colistimetato, o TIP durante al menos 1 ciclo (4 semanas con tratamiento seguidas de 4 semanas sin tratamiento) en los últimos 6 meses o
    ? uso continuo de colistimetato durante al menos 8 semanas en los últimos 6 meses
    Este ciclo de tratamiento (o período de tratamiento continuo con colistimetato) es además del ciclo de tratamiento durante el cual se está realizando la selección del paciente.
    6. La P. aeruginosa deberá estar presente en un cultivo de esputo o faringe profunda o lavado broncoalveolar (LBA) (sólo en el caso del LBA se precisa un nivel umbral de 103 UFC/mL) en los 6 meses anteriores a la selección y en el cultivo de esputo o faringe profunda en la selección o reselección (Visita 1)
    E.4Principal exclusion criteria
    *History of sputum culture or deep cough throat swab (or BAL) culture yielding Burkholderia cenocepacia complex within 2 years prior to prescreening or sputum culture yielding B. cenocepacia complex at screening (Visit 1)

    *History of hearing loss or chronic tinnitus deemed clinically significant by the investigator

    *Serum creatinine 89 ?mol/L or greater, BUN 5.7 ?mol/L or greater, creatinine clearance 50 mL/min or less, or an abnormal urinalysis defined as 2+ or greater proteinuria at screening

    *Known local or systemic hypersensitivity to aminoglycosides

    *Regularly receiving more than 1 class of inhaled antipseudomonal antibiotic.

    *Use of any investigational drug within 30 days or 5 half-lives, whichever is longer, prior to screening

    *Signs and symptoms of acute pulmonary disease, e.g., pneumonia, pneumothorax

    *Body mass index less than 12 kg/m2

    *History of malignancy of any organ system, treated or untreated

    *Clinically significant laboratory abnormalities (not associated with the study indication) at screening (Visit 1)

    *Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test

    *Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during study treatment.
    1. Antecedentes de cultivo de esputo o cultivo de exudado faríngeo profundo (o LBA) positivos para el complejo Burkholderia cenocepacia en un plazo de 2 años antes de la selección o cultivo de esputo que muestre el complejo B. cenocepacia en la selección (Visita 1)
    2. Hemoptisis superior a aproximadamente 60 mL en cualquier momento en los 30 días anteriores a la administración de la medicación del estudio (Visita 2)
    3. Antecedentes de pérdida auditiva o tinnitus crónico que el investigador considere clínicamente significativos
    4. Valor de creatinina sérica de 89 ?mol/L o superior, nitrógeno ureico en sangre (BUN) de 5,7 ?mol/L o superior, aclaramiento de creatinina de 50 mL/min o inferior, o resultados anormales en el análisis de orina definidos como proteinuria 2+ o superior en la selección (Visita 1)
    5. Hipersensibilidad local o sistémica conocida a los aminoglucósidos
    6. Recibe periódicamente más de una clase de antibiótico antipseudomona inhalado. Durante el estudio, no se permite el uso de antibióticos antipseudomonas inhalados distintos al antibiótico antipseudomona que el paciente esté utilizando en el momento de ser incluido en el estudio.
    7. Uso de antibióticos antipseudomonas sistémicos en un plazo de 28 días antes de la administración de la medicación del estudio (Visita 2)
    8. Para los pacientes en tratamiento con colistimetato: uso actual de medicaciones concomitantes a utilizar con precaución según se indica en la ficha técnica, incluidos aminoglucósidos, polimixinas, relajantes musculares curariformes (p. ej., tubocurarina), éter, succinilcolina, galamina, decametonio y citrato sódico, en la selección
    9. Uso de diuréticos del asa en los 7 días previos a la administración de la medicación del estudio (Visita 2)
    10. Uso de cualquier fármaco en investigación en los 30 días o 5 semividas, lo que sea más largo, antes de la selección (Visita 1)
    11. Signos y síntomas de enfermedad pulmonar aguda, p. ej., neumonía, neumotórax
    12. Índice de masa corporal inferior a 12 kg/m2
    13. Antecedentes de enfermedad maligna de cualquier sistema orgánico no relacionado con FQ, tratado o no tratado
    14. Anormalidades de laboratorio clínicamente significativas (no asociadas con la indicación del estudio) en la selección (Visita 1)
    15. Condiciones o hallazgos clínicamente significativos en la selección (Visita 1) que puedan interferir con la evaluación exacta y válida de este estudio
    16. Pacientes o cuidadores a quienes se considere potencialmente no fiables o improbable que cumplan con el ensayo.
    17. Mujeres embarazadas o en período de lactancia, donde el embarazo se define como el estado de una mujer después de la concepción y hasta la finalización de la gestación, confirmado mediante el resultado positivo de la prueba de laboratorio de gonadotropina coriónica humana (hCG)
    18. Mujeres en edad fértil, definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas, salvo que estén utilizando métodos de anticoncepción altamente eficaces durante el tratamiento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Total time for administration of TIP with the Podhaler compared to the total time for administration of TIS or colistimethate with nebulisers
    Tiempo total para la administracion de TIP con el Podhaler comparado con el tiempo total para la adminsitracion de TIS o colistimetato con nebulizadores
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days
    7 días
    E.5.2Secondary end point(s)
    1- Number of P. aeruginosa colony forming units (CFU)
    2- Frequency of microbial contamination of the T-326 Inhaler (Podhaler) compared with the contamination of the nebulizer used for the patient's usual nebulised antibiotic
    3- Averse event (AE) rates after each treatment cycle
    4- Change in the minimum inhibitory concentration (MIC) of the relevant antibiotic for P. aeruginosa
    5- Clinical laboratory results for TIP vs TIS and colistimethate after upto 28 days of treatment
    6- Type of microbial contamination of the T-326 Inhaler (Podhaler) compared with the contamination of the nebulizer used for the patient's usual nebulised antibiotic after upto 28 days of treatment in each treatment period
    1- numero de unidades formadoras de colonias (UFC) de P. aeruginosa
    2- Frecuencia de contaminación microbiana del inhalador T-326 (Podhaler) comparado con la contaminacion de los nebulizadores utilizados por el paciente con sus antibioticos habituales
    3- Tasa de acontecimientos adversos (AA) tras cada cada ciclo de tratamiento
    4- Cambio en la concentración inhibitoria minima (CMI) del antibiótico correspondiente para P. aeruginosa
    5- Resultados de laboratorio de TIP vs TIS y colistimetato después de un período de hasta 28 días de tratamiento
    6- Tipo de contaminación microbiana del DPI T-326 (Podhaler) en comparación con la contaminación del nebulizador utilizado para el tratamiento antibiótico nebulizado habitual del paciente después de un período de hasta 28 días de tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- 28 days post-treatment
    2- 28 days post-treatment
    3- 168 days
    4- 28 days post-treatment
    5- 28 days post-treatment
    6- 28 days post-treatment
    1- 28 dias post-tratamiento
    2- 28 dias post-tratamiento
    3- 168 dias
    4- 28 dias post-tratamiento
    5- 28 dias post-tratamiento
    6- 28 dias post-tratamiento
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Ease of use / time spent on treatment
    Facilidad de uso / tiempo empleado en el tratamiento
    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 Yes
    E.8.1.1Randomised No
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Tobramicina nebulizada, colistina nebulizada
    Nebulised tobramycin, nebulised colistin
    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 concerned5
    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
    Germany
    Spain
    Switzerland
    United Kingdom
    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 visit of the last subject
    ultima visita del ultimo paciente
    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 months4
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days20
    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: 30
    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: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 37
    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
    Patients under 18 years of age.
    Pacientes menores de 18 años de edad
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 67
    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
    Ninguno
    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 Decision2013-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-20
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA