Epidemiology of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease (COPD)
31 de outubro de 2016 atualizado por: AstraZeneca
A Cross-sectional Observational Study in Pulmonology Departments in Belgium and Luxembourg to Investigate the Epidemiology of Chronic Bronchitis in Patients Suffering From Moderate to Very Severe COPD
The purpose of this study was to investigate the prevalence of chronic bronchitis in patients suffering from moderate to very severe chronic obstructive pulmonary disease (COPD), and to assess the difference in exacerbation rates in patients suffering from moderate to very severe COPD with chronic bronchitis vs. a population of patients without chronic bronchitis.
Visão geral do estudo
Status
Concluído
Descrição detalhada
This was an observational study so participants only took medication that was prescribed by their regular healthcare provider.
No additional study medication was administered.
This study enrolled patients who were previously diagnosed with moderate to very severe chronic obstructive pulmonary disease (COPD).
This study looked at the prevalence of chronic bronchitis in patients suffering from moderate, severe or very severe COPD, and it also compared worsening of COPD in patients with or without chronic bronchitis.
This study enrolled 976 patients.
This multi-centre trial was conducted in Belgium and Luxembourg.
The overall time to participate in this study was at a single, regularly scheduled visit at the pulmonologists office.
There were no follow-up assessments for this study.
Tipo de estudo
Observacional
Inscrição (Real)
976
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
40 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
COPD patients with or without chronic bronchitis in Belgium and Luxembourg.
Descrição
Inclusion Criteria:
- 1. Written informed consent. 2. Age ≥ 40 years. 3. Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio (post-bronchodilator) <70%. 4. FEV1 (post-bronchodilator) < 80% of predicted.
Exclusion Criteria:
- 1. Moderate and severe exacerbations during the last 4 weeks. 2. Pregnancy. 3. Already participated in the study (allowed to participate only once).
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
Coortes e Intervenções
Grupo / Coorte |
|---|
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Chronic obstructive pulmonary disease
Patients with chronic obstructive pulmonary disease will undergo a single visit with the collection of data from his/her records.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants with Chronic Bronchitis
Prazo: 2 years prior to the study visit on Day 1
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Chronic bronchitis is defined as the presence of cough and sputum production for at least 3 months in each of 2 consecutive years.
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2 years prior to the study visit on Day 1
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Exacerbation Rate
Prazo: 12 Months prior to the study visit
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An exacerbation is defined as an event in the natural course of the disease characterised by a change in the patient's baseline dyspnoea, cough, and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD for three or more days.
Exacerbation rate is defined as number of exacerbations per year.
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12 Months prior to the study visit
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants with Moderate, Severe or Very Severe COPD
Prazo: At the study visit (Day 1)
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COPD severity will be assessed based on post-bronchodilator forced expiratory volume after 1 second (FEV1) and post-bronchodilator ratio of FEV1 to forced vital capacity (FVC) and then classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD): Moderate - FEV1/FVC<0.7, FEV1 50-79% normal; Severe - FEV1/FVC<0.70, FEV1 30-49% normal; Very Severe - FEV1/FVC<0.70, FEV1 <30% predicted or FEV1<50% predicted plus chronic respiratory failure.
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At the study visit (Day 1)
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Percentage of Participants with Risk Factors
Prazo: 12 months prior to study visit
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Risk factors are defined as smoking status and exposure to environmental risk factors (mineral dusts, organic dusts, fumes and vapours or metallic dusts).
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12 months prior to study visit
|
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Changes in Post-bronchodilator forced expiratory volume after 1 second (FEV1)
Prazo: At the study visit, and 6 months and 12 Months prior to study visit
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At the study visit, and 6 months and 12 Months prior to study visit
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|
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Percentage of Participants with Other Relevant Diseases
Prazo: 12 months prior to study visit
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Relevant disease are defined as respiratory diseases (allergy, asthma, chronic respiratory failure), cardiovascular diseases (ischaemic heart disease, heart failure, hypertension), and other diseases (which could be related to COPD) (osteoporosis, skeletal muscle wasting, cachexia, diabetes mellitus, depression, normocytic, anaemia, gastroesophageal reflux disease and lung cancer).
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12 months prior to study visit
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COPD Treatment
Prazo: At the study visit (Day 1)
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COPD treatments are defined as inhaled therapies, oral therapies and other therapies administered within the last 12 months as influenza vaccination and smoking cessation therapy.
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At the study visit (Day 1)
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Changes in post-bronchodilator ratio of FEV1 to forced vital capacity (FVC)
Prazo: At the study visit, and 6 months and 12 Months prior to study visit
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At the study visit, and 6 months and 12 Months prior to study visit
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Colaboradores e Investigadores
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Patrocinador
Datas de registro do estudo
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Datas Principais do Estudo
Início do estudo
1 de outubro de 2010
Conclusão Primária (Real)
1 de abril de 2011
Conclusão do estudo (Real)
1 de abril de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
29 de abril de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de abril de 2014
Primeira postagem (Estimativa)
1 de maio de 2014
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
2 de novembro de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
31 de outubro de 2016
Última verificação
1 de setembro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RO-2455-401-BE
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