- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00180765
Regulation of the Release of Inflammatory Mediators From Blood Leukocytes
Regulation of the Release of Inflammatory Mediators From Blood Leukocytes: A Comparison of Healthy Subjects, Healthy Smokers and Patients With COPD.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
The aim of this study is to investigate the mechanisms that regulate the survival of blood leukocytes as well as the synthesis and release of inflammatory mediators from cells from normal individuals and subjects with COPD. The hypothesis is that in COPD the life-span of leukocytes, such as the neutrophil, is enhanced and this may contribute to inflammation, a prominent characteristic of this disease, by secreting and releasing inflammatory mediators. We also suggest that differences may exist in the sensitivity of the various leukocytes to different therapies.
Leukocytes will be purified from the peripheral venous blood of patients with COPD as well as healthy individuals. We will then investigate the effects of novel and existing therapeutic agents on leukocyte survival and inflammatory mediator synthesis and release. We will also examine the regulation and release of enzymes known to damage lung tissue. Further studies will be carried out to elucidate the signal transduction pathways that lead to the activation, altered longevity and function of leukocytes. In other experiments ribonucleic acids or RNA may be extracted form leukocytes to investigate which genes are involved. The primary objective is to identify the mechanisms that enhance leukocyte longevity and inflammatory mediator and/or enzyme synthesis and release with a view to identifying novel targets for drug therapy.
Tipo de estudo
Contactos e Locais
Locais de estudo
-
-
London
-
Chelsea, London, Reino Unido, SW3 6LY
- National Heart & Lung Institute, Imperial College
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Healthy non-smoking subjects: All normal volunteers will meet the following criteria:
- Age 21-70 years.
- No history of respiratory or allergic disease.
- Normal baseline spirometry as predicted for age, sex and height.
- Non-smokers.
- No history of upper respiratory tract infection in the preceding six weeks.
- Not taking regular medication
COPD subjects: COPD is diagnosed according to American Thoracic Society, European Respiratory Society and British Thoracic Society guidelines by the doctors in Professor Barnes' COPD clinic. All COPD volunteers will meet the following criteria:
- Age between 40-75 years.
- A smoking history of at least 20 pack years. ( 1 pack year = 20 cigarettes per day for 1 year)
- FEV1:FVC ratio of <0.7, post-bronchodilator FEV1 of <85% predicted, reversibility with inhaled b2-agonist of <15% of predicted FEV1: all three criteria are required.
- Current smokers or smokers who had ceased smoking for at least 6 months.
- No history of exacerbation, oral steroid or antibiotic use within the preceding 6 weeks.
- Normal serum a-1 antitrypsin level.
- No history of other respiratory or allergic disease.
- No evidence of atopy on skin prick testing to common aeroallergens (grass pollen, cat hair, house dust mite or Aspergillus fumigatus
- These tests will have already been performed as part of routine assessment in Professor Barnes' COPD clinic and we will not need to repeat them for this study.
Healthy Smokers: All healthy smoking volunteers in trials will meet the following criteria:
- Age 21-70 years.
- Smoking history of at least 10 pack years (1 pack year = 20 cigarettes per day for 1 year).
- No history of respiratory or allergic disease.
- Normal baseline spirometry as predicted for age, sex and height.
- No history of upper respiratory tract infection in the preceding six weeks.
- Not taking regular medication.
Exclusion Criteria:
Subjects will not included in this study if they meet any of the following exclusion criteria:
- Clinically significant findings in the medical history or on physical examination other than those of COPD in the COPD group.
- Pregnant women or mothers who are breastfeeding.
- Subjects who are unable to give informed consent.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Peter J Barnes, DSc, National Heart & Lung Institute, Imperial College
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 01-215
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .