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Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma (DREAM)

18 de enero de 2018 actualizado por: GlaxoSmithKline

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Determine the Effect of Mepolizumab on Exacerbation Rates in Subjects With Severe Uncontrolled Refractory Asthma

The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma despite receiving high doses of standard asthma medications. The study will look at different doses of mepolizumab in comparison to a placebo.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

A double-blind, placebo-controlled study to evaluate the efficacy, safety and pharmacodynamics of three doses (75 mg, 250 mg and 750 mg) of mepolizumab intravenous (i.v.) administered every 4 weeks compared with placebo over a 52-week treatment period in subjects with severe uncontrolled refractory asthma. Efficacy will be measured by the frequency of asthma exacerbations. In addition lung function, rescue medication usage, daily symptoms, asthma control score, asthma quality of life score and withdrawals due to asthma exacerbations will be assessed. Safety will be assessed by adverse events, clinical laboratory evaluations, ECGs, immunogenicity and vital signs. Pharmacodynamics will be assessed by eosinophil levels in blood, serum IL-5 and eosinophil levels in induced sputum.

Tipo de estudio

Intervencionista

Inscripción (Actual)

621

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania, 10367
        • GSK Investigational Site
      • Berlin, Alemania, 10717
        • GSK Investigational Site
      • Berlin, Alemania, 14050
        • GSK Investigational Site
      • Berlin, Alemania, 12203
        • GSK Investigational Site
    • Brandenburg
      • Ruedersdorf, Brandenburg, Alemania, 15562
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Alemania, 60596
        • GSK Investigational Site
      • Frankfurt am Main, Hessen, Alemania, 60596
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Alemania, 55131
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Alemania, 39112
        • GSK Investigational Site
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Alemania, 23552
        • GSK Investigational Site
  • Argentina
      • Buenos Aires, Argentina, 1425
        • GSK Investigational Site
      • Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
        • GSK Investigational Site
      • Mendoza, Argentina, M5500CCG
        • GSK Investigational Site
      • Tucuman, Argentina, 4000
        • GSK Investigational Site
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, B7600FZN
        • GSK Investigational Site
  • Australia
    • New South Wales
      • New Lambton, New South Wales, Australia, 2305
        • GSK Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • GSK Investigational Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • GSK Investigational Site
      • Melbourne, Victoria, Australia, 3004
        • GSK Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • GSK Investigational Site
  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá, T2N 4Z6
        • GSK Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canadá, V5Z 1M9
        • GSK Investigational Site
    • Ontario
      • Mississauga, Ontario, Canadá, L5A 3V4
        • GSK Investigational Site
      • Mississauga, Ontario, Canadá, L5M 2V8
        • GSK Investigational Site
    • Quebec
      • Quebec City, Quebec, Canadá, G1V 4G5
        • GSK Investigational Site
  • Chile
      • Santiago, Chile, 8380453
        • GSK Investigational Site
      • Talcahuano, Chile, 4270918
        • GSK Investigational Site
    • Región Metro De Santiago
      • Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
        • GSK Investigational Site
    • Valparaíso
      • Valparaiso, Valparaíso, Chile, 2341131
        • GSK Investigational Site
  • Corea, república de
      • Bucheon-si,, Corea, república de, 420-767
        • GSK Investigational Site
      • Cheongju, Chungcheongbuk-do, Corea, república de, 361-711
        • GSK Investigational Site
      • Seoul, Corea, república de, 152-703
        • GSK Investigational Site
      • Seoul, Corea, república de, 133--792
        • GSK Investigational Site
      • Suwon, Kyonggi-do, Corea, república de, 443-721
        • GSK Investigational Site
  • Estados Unidos
    • California
      • Long Beach, California, Estados Unidos, 90808
        • GSK Investigational Site
      • Los Angeles, California, Estados Unidos, 90095
        • GSK Investigational Site
      • Riverside, California, Estados Unidos, 92506
        • GSK Investigational Site
      • San Diego, California, Estados Unidos, 92103-8415
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, Estados Unidos, 80206
        • GSK Investigational Site
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06510
        • GSK Investigational Site
    • Georgia
      • Albany, Georgia, Estados Unidos, 31707
        • GSK Investigational Site
      • Columbus, Georgia, Estados Unidos, 31904
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40508
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, Estados Unidos, 63110
        • GSK Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, Estados Unidos, 27103
        • GSK Investigational Site
    • Ohio
      • Canton, Ohio, Estados Unidos, 44718
        • GSK Investigational Site
      • Cleveland, Ohio, Estados Unidos, 44195
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73103
        • GSK Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos, 17033
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, Estados Unidos, PA 15213
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29406
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37203
        • GSK Investigational Site
    • Texas
      • Boerne, Texas, Estados Unidos, 78006
        • GSK Investigational Site
      • Houston, Texas, Estados Unidos, 77054
        • GSK Investigational Site
    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53792
        • GSK Investigational Site
  • Federación Rusa
      • Barnaul, Federación Rusa, 656 045
        • GSK Investigational Site
      • Chelyabinsk, Federación Rusa, 454106
        • GSK Investigational Site
      • Kazan, Federación Rusa, 420015
        • GSK Investigational Site
      • Moscow, Federación Rusa, 105 077
        • GSK Investigational Site
      • Moscow, Federación Rusa, 115478
        • GSK Investigational Site
      • Moscow, Federación Rusa, 123 182
        • GSK Investigational Site
      • Saint-Petersburg, Federación Rusa, 194354
        • GSK Investigational Site
      • St. Petersburg, Federación Rusa, 198216
        • GSK Investigational Site
      • Tomsk, Federación Rusa, 634001
        • GSK Investigational Site
  • Francia
      • Clamart, Francia, 92140
        • GSK Investigational Site
      • Marseille cedex 20, Francia, 13915
        • GSK Investigational Site
      • Montpellier, Francia, 34295
        • GSK Investigational Site
      • Nantes, Francia, 44093
        • GSK Investigational Site
      • Saint Pierre cedex, Francia, 97448
        • GSK Investigational Site
  • Polonia
      • Bialystok, Polonia, 15-276
        • GSK Investigational Site
      • Lodz, Polonia, 90-153
        • GSK Investigational Site
      • Warszawa, Polonia, 01-138
        • GSK Investigational Site
      • Wroclaw, Polonia, 54-239
        • GSK Investigational Site
      • Zawadzkie, Polonia, 47-120
        • GSK Investigational Site
      • Zgierz, Polonia, 95-100
        • GSK Investigational Site
  • Reino Unido
      • London, Reino Unido, E1 2AT
        • GSK Investigational Site
      • London, Reino Unido, SW3 6HP
        • GSK Investigational Site
      • Manchester, Reino Unido, M23 9LT
        • GSK Investigational Site
      • Southampton, Reino Unido, SO16 6YD
        • GSK Investigational Site
    • Leicestershire
      • Leicester, Leicestershire, Reino Unido, LE3 9QP
        • GSK Investigational Site
  • Rumania
      • Bucharest, Rumania, 050159
        • GSK Investigational Site
      • Bucuresti, Rumania, 70000
        • GSK Investigational Site
      • Iasi, Rumania, 700115
        • GSK Investigational Site
      • Targu Mures, Rumania, 540143
        • GSK Investigational Site
  • Ucrania
      • Cherkassy, Ucrania, 18009
        • GSK Investigational Site
      • Dnipropetrovsk, Ucrania, 49006
        • GSK Investigational Site
      • Dnipropetrovsk, Ucrania, 49051
        • GSK Investigational Site
      • Dnipropetrovsk, Ucrania, 49027
        • GSK Investigational Site
      • Donetsk, Ucrania, 83003
        • GSK Investigational Site
      • Donetsk, Ucrania, 83099
        • GSK Investigational Site
      • Kharkiv, Ucrania, 61035
        • GSK Investigational Site
      • Kiev, Ucrania, 03680
        • GSK Investigational Site
      • Kyiv, Ucrania, 03038
        • GSK Investigational Site
      • Kyiv, Ucrania, 03115
        • GSK Investigational Site
      • Mykolayiv, Ucrania, 54003
        • GSK Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años a 65 años (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Male or female
  • Aged 12 to 65 years inclusive
  • Minimum weight 45kg
  • Clinical features of severe refractory asthma
  • Well documented requirement for high dose inhaled corticosteroids (ICS) [i.e. >= 880mcg/day fluticasone propionate or equivalent daily] for at least 12 months
  • Using additional controller medication in addition to high dose ICS for at least 12 months
  • Persistent airflow obstruction indicated by a pre-bronchodilator FEV1<80% predicted at visit 1 or 2 or peak flow diurnal variability of >20% on 3 or more days during the run-in
  • Airway inflammation which is likely to be eosinophilic in nature demonstrated by either raised peripheral blood eosinophils (>=300/microL), sputum eosinophils (>=3%), exhaled nitric oxide (>=50ppb) or prompt deterioration of asthma control following a <=25% reduction in regular maintenance dose of inhaled or oral corticosteroids (OCS)
  • History of 2 or more exacerbations requiring systemic corticosteroids in the previous 12 months
  • Evidence of asthma documented by airway reversibility, airway hyperresponsiveness or airflow variability
  • ECG assessment demonstrating QTc<450msec or QTc<480msec for patients with bundle branch block
  • Liver function tests demonstrating ALT<2xUpper Limit of Normal (ULN), AST<2xULN, Alk Phos <=1.5xULN, bilirubin <=1.5xULN
  • Female of non-child-bearing potential or child-bearing potential with a negative pregnancy test at screening and prepared to agree to an acceptable method of contraception
  • Able to give written informed consent
  • Able to read, comprehend and write at a sufficient level to complete study materials

Exclusion Criteria:

  • Current smokers or smoking history of >=10 pack years
  • Clinically important lung condition other than asthma
  • Diagnosis of malignancy or in the process of investigation
  • Unstable liver disease
  • Churg-Strauss syndrome
  • Using methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine or any experimental anti-inflammatory therapy within 3 months of screening
  • Omalizumab (Xolair) or any other biological for the treatment of inflammatory disease within 6 months of Visit 1
  • Regular use of oral or systemic corticosteroids for diseases other than asthma within 12 months or any intra-articular, short-acting intramuscular corticosteroid within 1 month or intramuscular, long-acting depot corticosteroid within 3 months
  • Allergy/intolerance to the excipients in the mepolizumab formulation
  • Any investigational drug within 30 days or 5 terminal half-lives, whichever is longer
  • Pregnant or breastfeeding or planning to become pregnant
  • Clinically significant disease which is uncontrolled with standard treatment
  • History of alcohol misuse or substance abuse
  • Parasitic infestation within previous 6 months
  • Known immunodeficiency
  • Unable to follow instructions, use the electronic diary or peak flow meter
  • Known evidence of lack of adherence to controller medications and/or follow physician's recommendations
  • Previous participation in a study of mepolizumab and received study medication within 90 days

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Mepolizumab 750mg
Mepolizumab 750mcg i.v. every 4 weeks
Biológico: Mepolizumab 750
Mepolizumab 750mg every four weeks by i.v.
Comparador activo: Mepolizumab 250mg
Mepolizumab 250mcg i.v. every 4 weeks
Biológico: Mepolizumab 250
Mepolizumab 250mg every four weeks by i.v.
Comparador activo: Mepolizumab 75mg
Mepolizumab 75mcg i.v. every 4 weeks
Biológico: Mepolizumab 75
Mepolizumab 75mg every four weeks by i.v.
Comparador de placebos: Placebo
Placebo saline every 4 weeks i.v.
Droga: Placebo saline
Placebo saline every four weeks by i.v.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Clinically Significant Exacerbations of Asthma Per Year
Periodo de tiempo: From randomization (Week 0) to Week 52 or early withdrawal (EW)
Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance oral corticosteroids [OCS], an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or emergency department (ED) visit. The frequency of clinically significant exacerbations of asthma over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable
From randomization (Week 0) to Week 52 or early withdrawal (EW)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit
Periodo de tiempo: From randomization (Week 0) to Week 52 or EW
Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance OCS, an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).
From randomization (Week 0) to Week 52 or EW
Number of Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visit Per Year
Periodo de tiempo: From randomization (Week 0) to Week 52 or EW
The frequency of exacerbations of asthma requiring hospitalization (including intubation and admittance to an intensive care unit [ICU]) or ED visit over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.
From randomization (Week 0) to Week 52 or EW
Time to First Exacerbation Requiring Hospitalization or ED Visit
Periodo de tiempo: From randomization (Week 0) to Week 52 or EW
Exacerbations of asthma requiring hospitalization or ED visit were assessed. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).
From randomization (Week 0) to Week 52 or EW
Number of All Recorded Exacerbations Per Year
Periodo de tiempo: From randomization (Week 0) to Week 52 or EW
Clinically significant exacerbations (ex) of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for par. on maintenance OCS, an ex requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. In the case, an event described as an ex was not associated with a deterioration in >=1 of the objectives of eDiary parameters, the investigator (inv) provided an explanation to support the decision for defining the event as an ex. All recorded ex were defined as those recorded by inv, regardless of the outcome of the ex review process. Analysis was performed using Negative Binomial regression model with covariates of treatment group, BL maintenance OCS therapy (OCS vs. no OCS), region, ex in the year prior to the study (as an ordinal variable) and BL % predicted FEV1, and with logarithm of time on treatment as an offset variable.
From randomization (Week 0) to Week 52 or EW
Time to First All Recorded Exacerbation
Periodo de tiempo: From randomization (Week 0) to Week 52 or EW
All recorded exacerbations are defined as those recorded by investigators, regardless of the outcome of the exacerbation review process. In the case, an event described as an exacerbation was not associated with a deterioration in at least one of the objectives of eDiary parameters, the investigator provided an explanation to support the decision for defining the event as an exacerbation. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by week 16, week 32 and week 52).
From randomization (Week 0) to Week 52 or EW
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period
Periodo de tiempo: From Baseline up to Week 52 or EW
FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at each clinic visit. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.
From Baseline up to Week 52 or EW
Mean Change From Baseline in Clinic Post-bronchodilator FEV1 Over the 52-week Treatment Period
Periodo de tiempo: From Baseline up to Week 52 or EW
FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Post-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 32 and Week 52. Post bronchodilator values were recorded following reversibility testing, using the maximum post bronchodilator method. Participants unable to achieve >=12% reversibility and 200 mL change at Visit 1, reversibility test was repeated at Visit 2. These procedures to achieve the maximum post-bronchodilator are generated by the Asthma Clinical Research Network. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment
From Baseline up to Week 52 or EW
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period
Periodo de tiempo: From Baseline up to Week 52 or EW
The ACQ-6 is a six-item questionnaire. The six questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze) and use of short-acting bronchodilator over the previous week. The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 6 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). Change from BL is defined as the difference between the value of the endpoint at the time point of interest and BL value. Analysis was performed using mixed model repeated measures with covariates of BL, region, BL maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), BL % predicted FEV1, treatment and visit, plus interaction terms for visit by BL and visit by treatment group.
From Baseline up to Week 52 or EW

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

GlaxoSmithKline

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de noviembre de 2009

Finalización primaria (Actual)

23 de marzo de 2012

Finalización del estudio (Actual)

23 de marzo de 2012

Fechas de registro del estudio

Enviado por primera vez

22 de octubre de 2009

Primero enviado que cumplió con los criterios de control de calidad

22 de octubre de 2009

Publicado por primera vez (Estimar)

23 de octubre de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de enero de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

18 de enero de 2018

Última verificación

1 de enero de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 112997

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Sí

Descripción del plan IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Datos del estudio/Documentos

  1. Formulario de informe de caso anotado
    Identificador de información: 112997
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  2. Formulario de consentimiento informado
    Identificador de información: 112997
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  3. Plan de Análisis Estadístico
    Identificador de información: 112997
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  4. Protocolo de estudio
    Identificador de información: 112997
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  5. Conjunto de datos de participantes individuales
    Identificador de información: 112997
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  6. Especificación del conjunto de datos
    Identificador de información: 112997
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  7. Informe de estudio clínico
    Identificador de información: 112997
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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