Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Viapaed Study In Children And Adolescents With Asthma

18 de outubro de 2017 atualizado por: GlaxoSmithKline

Steroid-sparing Management of the Salmeterol/Fluticasone 50/100µg b.i.d. Combination Compared to Fluticasone 200µg b.i.d. in Children and Adolescents With Moderate Asthma

Asthmatic children who remain symptomatic on inhaled corticosteroids (ICS) require an adjustment of their asthma therapy. Current guidelines suggest that the treatment options are either an increased dose of inhaled corticosteroid or the addition of other therapy such as a long-acting beta-agonist (LABA). In the pediatric age range, major concerns with respect to high dose ICS therapy are growth retardation and the suppression of the hypothalamic-pituitary-adrenocortical (HPA) axis. Previous studies in adults have shown that a combination product that included a LABA as well as the ICS allowed to reduce the steroid dose and was still at least as effective in achieving asthma control as treatment with a higher dose of ICS. These treatment options shall be compared in the present study. Children who remain symptomatic while inhaling 100 µg fluticasone (FP) twice daily shall be randomized to receive the salmeterol/ fluticasone combination product, Viani (SERETIDE) 50/100 µg, or fluticasone 200 µg as a comparator drug, inhaled twice daily via the DISKUS for a period of eight weeks.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

285

Estágio

  • Fase 4

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, 10967
        • GSK Investigational Site
      • Berlin, Alemanha, 13055
        • GSK Investigational Site
      • Berlin, Alemanha, 13347
        • GSK Investigational Site
      • Berlin, Alemanha, 10965
        • GSK Investigational Site
      • Berlin, Alemanha, 12167
        • GSK Investigational Site
      • Berlin, Alemanha, 10365
        • GSK Investigational Site
      • Berlin, Alemanha, 13355
        • GSK Investigational Site
      • Berlin, Alemanha, 10785
        • GSK Investigational Site
      • Berlin, Alemanha, 14163
        • GSK Investigational Site
      • Berlin, Alemanha, 10997
        • GSK Investigational Site
      • Berlin, Alemanha, 12161
        • GSK Investigational Site
      • Hamburg, Alemanha, 22415
        • GSK Investigational Site
      • Hamburg, Alemanha, 22045
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Bad Krozingen, Baden-Wuerttemberg, Alemanha, 79189
        • GSK Investigational Site
      • Boennigheim, Baden-Wuerttemberg, Alemanha, 74357
        • GSK Investigational Site
      • Ettenheim, Baden-Wuerttemberg, Alemanha, 77955
        • GSK Investigational Site
      • Heidelberg, Baden-Wuerttemberg, Alemanha, 69115
        • GSK Investigational Site
      • Kehl, Baden-Wuerttemberg, Alemanha, 77694
        • GSK Investigational Site
      • Konstanz, Baden-Wuerttemberg, Alemanha, 78464
        • GSK Investigational Site
      • Mannheim, Baden-Wuerttemberg, Alemanha, 68167
        • GSK Investigational Site
      • Pfullendorf, Baden-Wuerttemberg, Alemanha, 88630
        • GSK Investigational Site
      • Schwaebisch-Hall, Baden-Wuerttemberg, Alemanha, 74523
        • GSK Investigational Site
      • Schwetzingen, Baden-Wuerttemberg, Alemanha, 68723
        • GSK Investigational Site
      • Sinsheim, Baden-Wuerttemberg, Alemanha, 74889
        • GSK Investigational Site
      • Stuttgart, Baden-Wuerttemberg, Alemanha, 70469
        • GSK Investigational Site
      • Stuttgart, Baden-Wuerttemberg, Alemanha, 70499
        • GSK Investigational Site
      • Tauberbischofsheim, Baden-Wuerttemberg, Alemanha, 97941
        • GSK Investigational Site
      • Tuttlingen, Baden-Wuerttemberg, Alemanha, 78532
        • GSK Investigational Site
      • Villingen-Schwenningen, Baden-Wuerttemberg, Alemanha, 78056
        • GSK Investigational Site
      • Welzheim, Baden-Wuerttemberg, Alemanha, 73642
        • GSK Investigational Site
    • Bayern
      • Bobingen, Bayern, Alemanha, 86399
        • GSK Investigational Site
      • Forchheim, Bayern, Alemanha, 91301
        • GSK Investigational Site
      • Freising, Bayern, Alemanha, 85354
        • GSK Investigational Site
      • Kaufbeuren, Bayern, Alemanha, 87600
        • GSK Investigational Site
      • Lauf, Bayern, Alemanha, 91207
        • GSK Investigational Site
      • Muenchen, Bayern, Alemanha, 81241
        • GSK Investigational Site
      • Muenchen, Bayern, Alemanha, 80337
        • GSK Investigational Site
      • Muenchen, Bayern, Alemanha, 80939
        • GSK Investigational Site
      • Noerdlingen, Bayern, Alemanha, 86720
        • GSK Investigational Site
      • Nuernberg, Bayern, Alemanha, 90473
        • GSK Investigational Site
      • Nuernberg, Bayern, Alemanha, 90449
        • GSK Investigational Site
      • Olching, Bayern, Alemanha, 82140
        • GSK Investigational Site
      • Pegnitz, Bayern, Alemanha, 91257
        • GSK Investigational Site
      • Rosenheim, Bayern, Alemanha, 83026
        • GSK Investigational Site
    • Berlin
      • Friedrichsfelde, Berlin, Alemanha, 10315
        • GSK Investigational Site
    • Brandenburg
      • Frankfurt/Oder, Brandenburg, Alemanha, 15236
        • GSK Investigational Site
      • Schwedt, Brandenburg, Alemanha, 16303
        • GSK Investigational Site
    • Hessen
      • Braunfels, Hessen, Alemanha, 35619
        • GSK Investigational Site
      • Frankfurt, Hessen, Alemanha, 60316
        • GSK Investigational Site
      • Kassel, Hessen, Alemanha, 34121
        • GSK Investigational Site
      • Niedernhausen, Hessen, Alemanha, 65527
        • GSK Investigational Site
      • Wetzlar, Hessen, Alemanha, 35576
        • GSK Investigational Site
      • Wiesbaden, Hessen, Alemanha, 65205
        • GSK Investigational Site
    • Niedersachsen
      • Belm, Niedersachsen, Alemanha, 49191
        • GSK Investigational Site
      • Hannover, Niedersachsen, Alemanha, 30625
        • GSK Investigational Site
      • Lueneburg, Niedersachsen, Alemanha, 21339
        • GSK Investigational Site
      • Osnabrueck, Niedersachsen, Alemanha, 49082
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Alemanha, 52072
        • GSK Investigational Site
      • Bielefeld, Nordrhein-Westfalen, Alemanha, 33617
        • GSK Investigational Site
      • Bochum, Nordrhein-Westfalen, Alemanha, 44791
        • GSK Investigational Site
      • Bochum, Nordrhein-Westfalen, Alemanha, 44866
        • GSK Investigational Site
      • Bochum, Nordrhein-Westfalen, Alemanha, 44795
        • GSK Investigational Site
      • Bochum, Nordrhein-Westfalen, Alemanha, 44789
        • GSK Investigational Site
      • Bottrop, Nordrhein-Westfalen, Alemanha, 46242
        • GSK Investigational Site
      • Detmold, Nordrhein-Westfalen, Alemanha, 32756
        • GSK Investigational Site
      • Dortmund, Nordrhein-Westfalen, Alemanha, 44137
        • GSK Investigational Site
      • Duesseldorf, Nordrhein-Westfalen, Alemanha, 40225
        • GSK Investigational Site
      • Duesseldorf, Nordrhein-Westfalen, Alemanha, 40599
        • GSK Investigational Site
      • Duisburg, Nordrhein-Westfalen, Alemanha, 47137
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Alemanha, 45122
        • GSK Investigational Site
      • Euskirchen, Nordrhein-Westfalen, Alemanha, 53879
        • GSK Investigational Site
      • Guetersloh, Nordrhein-Westfalen, Alemanha, 33332
        • GSK Investigational Site
      • Halle, Nordrhein-Westfalen, Alemanha, 33790
        • GSK Investigational Site
      • Kempen, Nordrhein-Westfalen, Alemanha, 47906
        • GSK Investigational Site
      • Kleve-Materborn, Nordrhein-Westfalen, Alemanha, 47533
        • GSK Investigational Site
      • Krefeld, Nordrhein-Westfalen, Alemanha, 47389
        • GSK Investigational Site
      • Minden, Nordrhein-Westfalen, Alemanha, 32427
        • GSK Investigational Site
      • Neuss, Nordrhein-Westfalen, Alemanha, 41462
        • GSK Investigational Site
      • Neuss, Nordrhein-Westfalen, Alemanha, 41469
        • GSK Investigational Site
      • Oberhausen, Nordrhein-Westfalen, Alemanha, 46145
        • GSK Investigational Site
      • Remscheid, Nordrhein-Westfalen, Alemanha, 42899
        • GSK Investigational Site
      • Wesel, Nordrhein-Westfalen, Alemanha, 46483
        • GSK Investigational Site
      • Willich, Nordrhein-Westfalen, Alemanha, 47877
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Koblenz, Rheinland-Pfalz, Alemanha, 56068
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Alemanha, 55131
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Alemanha, 55127
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Alemanha, 54294
        • GSK Investigational Site
    • Sachsen
      • Cossebaude, Sachsen, Alemanha, 01462
        • GSK Investigational Site
      • Doebeln, Sachsen, Alemanha, 04720
        • GSK Investigational Site
      • Dresden, Sachsen, Alemanha, 01067
        • GSK Investigational Site
      • Dresden, Sachsen, Alemanha, 01169
        • GSK Investigational Site
      • Leipzig, Sachsen, Alemanha, 04317
        • GSK Investigational Site
      • Leipzig, Sachsen, Alemanha, 04279
        • GSK Investigational Site
      • Wurzen, Sachsen, Alemanha, 04808
        • GSK Investigational Site
    • Schleswig-Holstein
      • Flensburg, Schleswig-Holstein, Alemanha, 24944
        • GSK Investigational Site
      • Geesthacht, Schleswig-Holstein, Alemanha, 21502
        • GSK Investigational Site
      • Harrislee, Schleswig-Holstein, Alemanha, 24955
        • GSK Investigational Site
    • Thueringen
      • Neuhaus am Rennweg, Thueringen, Alemanha, 98724
        • 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

4 anos a 16 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Children aged 4 to 16 years with an established history of perennial asthma.
  • Subjects who are treated with an inhaled corticosteroid according to BDP (budesonide) 200-400 µg/day or equivalent during the last 4 weeks before run-in.
  • 15 minutes after inhaling 200µg of salbutamol, reversible increase in FEV1 of at least 12% of the pre-dose value.
  • Willingness to substitute previous controller medication on the twice daily inhalation of fluticasone 100µg bid via DISKUS®.
  • Subjects/guardians who have given written informed consent to participate in the study.
  • Subjects /guardians who are able to understand and complete a diary record card (DRC).
  • Subjects who are able to use a Mini-Wright Peak Flow meter.
  • Sexually active female adolescents must use adequate contraception.
  • Willingness to refrain from any other controller medication (including anti-leukotrienes) or from regular use of short-acting beta agonists or anticholinergics during the treatment period.

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

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Subjects receiving salmeterol/fluticasone
Eligible subjects will receive 60 individual doses of the salmeterol 50 microgram/ fluticasone 100 microgram combination. Subjects will also receive placebo.
Medicamento: Salmeterol/fluticasone
Salmeterol/ fluticasone are a type of long acting beta-agonist (LABA). Salmeterol 50 microgram/ fluticasone 100 microgram combination will be administered to eligible subjects via inhalation route.
Medicamento: Salbutamol
Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.
Comparador Ativo: Subjects receiving fluticasone
Eligible subjects will receive 60 individual fluticasone 100 microgram doses each.
Medicamento: Salbutamol
Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.
Medicamento: Fluticasone propionate
Fluticasone propionate is a type of LABA. Fluticasone 100 microgram dose will be administered to eligible subjects via inhalation route.
Outros nomes:
  • SERETIDE
  • Salmeterol

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change from Baseline in mean morning peak expiratory flow (PEF)
Prazo: Baseline up to Week 8
The PEF is a person's maximum speed of expiration. PEF will be measured using a mini wright peak flow meter and will be documented daily at morning in the diary of subjects
Baseline up to Week 8

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Daily Asthma symptom score
Prazo: Up to Week 8
Asthma symptoms will be recorded separately for night and day using 2 symptom scores. Symptoms included will be coughing, wheezing, shortness of breath, feeling of tightness in the chest and nocturnal waking due to 1 or more of these symptoms. Score will range from 0-4 where 0 = no complaints and 4= person could not sleep due to asthma symptoms.
Up to Week 8
Number of calendar days without asthma symptoms
Prazo: Up to Week 8
Number of calendar days without asthma symptoms will be defined as the sum of all days for which the patient documented an asthma symptom score of 0 (no complaints) for the day and the previous night.
Up to Week 8
Number of necessary administrations of salbutamol
Prazo: Up to Week 8
The number of necessary administrations of salbutamol will be documented daily by subjects in the diary.
Up to Week 8
Number of weeks with good asthma control
Prazo: Up to Week 8
One week of well controlled asthma will be defined by fulfilling the following criteria: at least 2 of the following criteria (type A): symptoms with a symptom score >1 on at most 2 days, use of rescue medication maximally 4 x per week, morning PEF daily >=80% of the predicted normal value and all the following criteria (type B): no nocturnal waking due to bronchial asthma, no exacerbations, no out-patient or hospitalized emergency treatment due to asthma, no adverse events due to administration of the study medication which would have necessitated a change of treatment, no intolerance or refusal of study medication
Up to Week 8
Change in forced vital capacity (FVC) in % of reference value
Prazo: Up to Week 8
FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deep breath.
Up to Week 8
Change in forced expiratory volume in 1 second (FEV1) in % of reference value
Prazo: Up to Week 8
FEV1 is the volume of air exhaled under forced conditions in 1 second.
Up to Week 8
Change in peak expiratory flow rate (PEFR) in % of reference value
Prazo: Up to Week 8
PEFR is a person's maximum speed of expiration.
Up to Week 8
Change in mean morning peak flow in % of reference value
Prazo: Up to Week 8
The PEF is a person's maximum speed of expiration. PEF will be measured using a mini wright peak flow meter
Up to Week 8
Percentage of subjects with a peak flow variability of 20%
Prazo: Up to Week 8
Morning versus evening peak flow will be calculated and compared.
Up to Week 8
Number of subject withdrawals due to asthma exacerbations
Prazo: Up to Week 8
Asthma exacerbations are acute or sub acute episodes, which are characterized by a progressive increase in one or more typical asthma symptoms.
Up to Week 8
Number of subjects with adverse events (AEs)
Prazo: Up to Week 8
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Up to Week 8

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 (Real)

4 de novembro de 2004

Conclusão Primária (Real)

12 de abril de 2007

Conclusão do estudo (Real)

12 de abril de 2007

Datas de inscrição no estudo

Enviado pela primeira vez

17 de abril de 2006

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de abril de 2006

Primeira postagem (Estimativa)

19 de abril de 2006

Atualizações de registro de estudo

Última Atualização Postada (Real)

19 de outubro de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de outubro de 2017

Última verificação

1 de outubro de 2017

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 102318

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. Especificação do conjunto de dados
    Identificador de informação: 102318
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  2. Plano de Análise Estatística
    Identificador de informação: 102318
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  3. Conjunto de dados de participantes individuais
    Identificador de informação: 102318
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  4. Formulário de Consentimento Informado
    Identificador de informação: 102318
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  5. Protocolo de estudo
    Identificador de informação: 102318
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  6. Relatório de Estudo Clínico
    Identificador de informação: 102318
    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 .

Ensaios clínicos em Salmeterol/fluticasone

Pesquisar ensaios semelhantes

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

CROs by country

CROs in Chile

Condições

Doenças Raras

Intervenções de drogas

Suplementos Alimentares

Patrocinador / Colaboradores

Localizações

3
Se inscrever