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

18 de janeiro de 2018 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

621

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Berlin, Alemanha, 10367
        • GSK Investigational Site
      • Berlin, Alemanha, 10717
        • GSK Investigational Site
      • Berlin, Alemanha, 14050
        • GSK Investigational Site
      • Berlin, Alemanha, 12203
        • GSK Investigational Site
    • Brandenburg
      • Ruedersdorf, Brandenburg, Alemanha, 15562
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Alemanha, 60596
        • GSK Investigational Site
      • Frankfurt am Main, Hessen, Alemanha, 60596
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Alemanha, 55131
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Alemanha, 39112
        • GSK Investigational Site
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Alemanha, 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
  • Austrália
    • New South Wales
      • New Lambton, New South Wales, Austrália, 2305
        • GSK Investigational Site
    • South Australia
      • Adelaide, South Australia, Austrália, 5000
        • GSK Investigational Site
    • Victoria
      • Clayton, Victoria, Austrália, 3168
        • GSK Investigational Site
      • Melbourne, Victoria, Austrália, 3004
        • GSK Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Austrália, 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
  • 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
  • Federação Russa
      • Barnaul, Federação Russa, 656 045
        • GSK Investigational Site
      • Chelyabinsk, Federação Russa, 454106
        • GSK Investigational Site
      • Kazan, Federação Russa, 420015
        • GSK Investigational Site
      • Moscow, Federação Russa, 105 077
        • GSK Investigational Site
      • Moscow, Federação Russa, 115478
        • GSK Investigational Site
      • Moscow, Federação Russa, 123 182
        • GSK Investigational Site
      • Saint-Petersburg, Federação Russa, 194354
        • GSK Investigational Site
      • St. Petersburg, Federação Russa, 198216
        • GSK Investigational Site
      • Tomsk, Federação Russa, 634001
        • GSK Investigational Site
  • França
      • Clamart, França, 92140
        • GSK Investigational Site
      • Marseille cedex 20, França, 13915
        • GSK Investigational Site
      • Montpellier, França, 34295
        • GSK Investigational Site
      • Nantes, França, 44093
        • GSK Investigational Site
      • Saint Pierre cedex, França, 97448
        • GSK Investigational Site
  • Polônia
      • Bialystok, Polônia, 15-276
        • GSK Investigational Site
      • Lodz, Polônia, 90-153
        • GSK Investigational Site
      • Warszawa, Polônia, 01-138
        • GSK Investigational Site
      • Wroclaw, Polônia, 54-239
        • GSK Investigational Site
      • Zawadzkie, Polônia, 47-120
        • GSK Investigational Site
      • Zgierz, Polônia, 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
  • Republica da Coréia
      • Bucheon-si,, Republica da Coréia, 420-767
        • GSK Investigational Site
      • Cheongju, Chungcheongbuk-do, Republica da Coréia, 361-711
        • GSK Investigational Site
      • Seoul, Republica da Coréia, 152-703
        • GSK Investigational Site
      • Seoul, Republica da Coréia, 133--792
        • GSK Investigational Site
      • Suwon, Kyonggi-do, Republica da Coréia, 443-721
        • GSK Investigational Site
  • Romênia
      • Bucharest, Romênia, 050159
        • GSK Investigational Site
      • Bucuresti, Romênia, 70000
        • GSK Investigational Site
      • Iasi, Romênia, 700115
        • GSK Investigational Site
      • Targu Mures, Romênia, 540143
        • GSK Investigational Site
  • Ucrânia
      • Cherkassy, Ucrânia, 18009
        • GSK Investigational Site
      • Dnipropetrovsk, Ucrânia, 49006
        • GSK Investigational Site
      • Dnipropetrovsk, Ucrânia, 49051
        • GSK Investigational Site
      • Dnipropetrovsk, Ucrânia, 49027
        • GSK Investigational Site
      • Donetsk, Ucrânia, 83003
        • GSK Investigational Site
      • Donetsk, Ucrânia, 83099
        • GSK Investigational Site
      • Kharkiv, Ucrânia, 61035
        • GSK Investigational Site
      • Kiev, Ucrânia, 03680
        • GSK Investigational Site
      • Kyiv, Ucrânia, 03038
        • GSK Investigational Site
      • Kyiv, Ucrânia, 03115
        • GSK Investigational Site
      • Mykolayiv, Ucrânia, 54003
        • GSK Investigational Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

12 anos a 65 anos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Mepolizumab 750mg
Mepolizumab 750mcg i.v. every 4 weeks
Biológico: Mepolizumab 750
Mepolizumab 750mg every four weeks by i.v.
Comparador Ativo: Mepolizumab 250mg
Mepolizumab 250mcg i.v. every 4 weeks
Biológico: Mepolizumab 250
Mepolizumab 250mg every four weeks by i.v.
Comparador Ativo: Mepolizumab 75mg
Mepolizumab 75mcg i.v. every 4 weeks
Biológico: Mepolizumab 75
Mepolizumab 75mg every four weeks by i.v.
Comparador de Placebo: Placebo
Placebo saline every 4 weeks i.v.
Medicamento: Placebo saline
Placebo saline every four weeks by i.v.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Clinically Significant Exacerbations of Asthma Per Year
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

GlaxoSmithKline

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de novembro de 2009

Conclusão Primária (Real)

23 de março de 2012

Conclusão do estudo (Real)

23 de março de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

22 de outubro de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de outubro de 2009

Primeira postagem (Estimativa)

23 de outubro de 2009

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de janeiro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de janeiro de 2018

Última verificação

1 de janeiro de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 112997

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Sim

Descrição do plano IPD

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

Dados/documentos do estudo

  1. Formulário de Relato de Caso Anotado
    Identificador de informação: 112997
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  2. Formulário de Consentimento Informado
    Identificador de informação: 112997
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  3. Plano de Análise Estatística
    Identificador de informação: 112997
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  4. Protocolo de estudo
    Identificador de informação: 112997
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  5. Conjunto de dados de participantes individuais
    Identificador de informação: 112997
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  6. Especificação do conjunto de dados
    Identificador de informação: 112997
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  7. Relatório de Estudo Clínico
    Identificador de informação: 112997
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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