The BLF Early COPD Development Partnership Grant
Most existing medical research has focused on patients with well-established COPD and poor lung function. Whilst this is important because such patients have lots of symptoms and problems, in some respects a better way of reducing health problems in the future would be to develop a strategy which focuses on patients with milder disease, and identifies which ones will go on to develop more severe problems and why these problems occur. The research in this application is designed to investigate these issues.
The main objective of the Partnership is to study the very early stages of the development of COPD. The investigators will do this by recruiting a novel cohort of smokers (age 30-45), in whom the investigators will follow the trajectories of lung function decline to identify prospectively those at risk of excess decline. This programme forms a unique UK consortium of 8 academic centres with excellent high quality publication records and broad experience in mechanistic, translational, clinical and epidemiological studies in COPD with key capabilities including primary care.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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London, Reino Unido
- Royal Brompton and Harefield NHS Foundation Trust
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
Subjects eligible for enrolment in the study must meet all the following criteria:
- Informed Consent: Subjects must give their signed and dated written informed consent to participate
- Gender: Male or female subjects
- Age: 30-45 years of age at screening
- Smokers of at least 10 pack years
- Have either normal lung function or mild lung function abnormalities
Subject groups will have one of the following:
- A. Subjects (smokers) with mild airflow limitation defined as an FEV1/FVC ratio <lower limit of normal and FEV1 > 80% of predicted normal and no symptoms. This group will make up at least 30% of the total cohort.
- B. Subjects (smokers) with mild airflow limitation as defined above and presence of respiratory symptoms defined as presence of chronic cough and/or chronic sputum and/or breathlessness equivalent to mMRC Grade 1 or higher. This group will make up no more than 25% of the total cohort.
- C. Subjects (smokers) with normal lung function defined as FEV1/FVC > lower limit of normal and FEV1 > 80% of predicted normal, with or without symptoms. This group will make up at least 30% of the total cohort.
Exclusion Criteria:
- Individuals currently diagnosed and treated for asthma will be excluded from the study, but individuals with a past history of childhood wheezing and of asthma may be included provided that they did not previously receive regular maintenance inhaled therapy with inhaled corticosteroids'
- Subjects with another known chronic respiratory disease - other than mild airflow limitation as defined above, predominantly cannabis or shisha smokers
- Subjects with autoimmune disease, diabetes, hypertension, thyroid disease or bronchiectasis, significant cardio-renal disease (including significant hypertension, atrial fibrillation, Hypertrophic Cardiomyopathy, significant cardiovascular disease), Malignancies.
- Clinically relevant abnormal laboratory values available at the screening assessment that could interfere with the objectives of the study or safety of the volunteer.
- Subjects who are actively enrolled in an interventional clinical trial
- Subjects with BMI >35
- Female participants who are pregnant or breastfeeding.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Annual change in lung function
Prazo: Three years
|
assessed by post-bronchodilator at 6 monthly intervals over a 3 year period.
|
Three years
|
|
Annual change in lung function
Prazo: Three years
|
assessed by body box plethysmography at 6 monthly intervals over a 3 year period.
|
Three years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Lung tissue attenuation and airway dimensions
Prazo: Three years
|
determined by CT-Scanning
|
Three years
|
|
Lung tissue attenuation and airway dimensions
Prazo: Three years
|
Assessed by full blood and differential counts
|
Three years
|
|
Lung tissue attenuation and airway dimensions
Prazo: Three years
|
Assessed by prevalence of chronic bronchitis as determined by MRC Bronchitis Questionnaire
|
Three years
|
|
Lung tissue attenuation and airway dimensions
Prazo: Three years
|
Assessed by respiratory symptoms, as determined by CAT Questionnaire
|
Three years
|
|
Lung tissue attenuation and airway dimensions
Prazo: Three years
|
Assessed by dyspnoea as determined by MRC Dyspnoa Scale
|
Three years
|
|
Lung tissue attenuation and airway dimensions
Prazo: Three years
|
Assessed by respiratory infections as determined by Respiratory Infection Questionnaire
|
Three years
|
|
Lung tissue attenuation and airway dimensions
Prazo: Three years
|
Assessed by depression and anxiety as determined by Hospital Anxiety Depression Scale
|
Three years
|
Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRAS Project ID: 206796
Informações sobre medicamentos e dispositivos, documentos de estudo
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