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临床试验/NCT01185652
NCT01185652Unknown不适用

A Study on Smoking-related Lung Function Abnormalities and Correlation With Serum Biomarkers in Chinese

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Spirometry parameters

研究概览

简要总结

Tobacco-smoking causes lung function decline with airflow obstruction, which may be accelerated in persistent smokers.This would eventually lead to chronic obstructive pulmonary disease (COPD), a leading cause of morbidity and mortality in Hong Kong and globally. Lung function decline is gradual and not appreciated by the smoker until damage is advanced, and often under-recognised in the early stages of disease by healthcare providers. Spirometry is an established lung function measurement tool, and the most simple objective method to detect lung function decline. There is literature suggesting that newer spirometric parameters, FEV3 and FEV6, which are easier to achieve in the measurement process than conventional parameters, are comparable alternatives in detecting lung function decline.

The aims of this study are:

  1. to evaluate and compare lung function decline in persistent smokers and non-smokers
  2. to study the usefulness of FEV3/FVC and FEV1/FEV6 in detecting lung function decline
  3. to correlate symptom scores with lung function parameters
  4. To correlate serum biomarker levels with respiratory symptoms and lung function parameters in smokers and non-smokers

This is a follow-up study on a territory wide cohort including smokers and non-smokers, who have undergone lung function testing in 2001-03. Subjects will be invited to have repeat lung function assessment.

The hypotheses of this study are:

  1. smokers have significantly greater decline in lung function compared to non-smokers in Hong Kong Chinese;
  2. newer lung function parameters are useful alternatives in detecting lung function decline
  3. serum inflammatory biomarker (IL-8, TGF-β, MMP9, TIMP-1, CRP) levels correlate with respiratory symptoms and lung function parameters in smokers when compared with non-smokers

详细描述

Tobacco-smoking causes lung function decline with airflow obstruction, which may be accelerated in persistent smokers.This would eventually lead to chronic obstructive pulmonary disease (COPD), a leading cause of morbidity and mortality in Hong Kong and globally. Lung function decline is gradual and not appreciated by the smoker until damage is advanced, and often under-recognised in the early stages of disease by healthcare providers. Spirometry is an established lung function measurement tool, and the most simple objective method to detect lung function decline. There is literature suggesting that newer spirometric parameters, FEV3 and FEV6, which are easier to achieve in the measurement process than conventional parameters, are comparable alternatives in detecting lung function decline.

The aims of this study are:

  1. to evaluate and compare lung function decline in persistent smokers and non-smokers
  2. to study the usefulness of FEV3/FVC and FEV1/FEV6 in detecting lung function decline
  3. to correlate symptom scores with lung function parameters
  4. To correlate serum biomarker levels with respiratory symptoms and lung function parameters in smokers and non-smokers

This is a follow-up study on a territory wide cohort including smokers and non-smokers, who have undergone lung function testing in 2001-03. Subjects will be invited to have repeat lung function assessment.

The demonstration of excessive lung function decline in the local smoking population would reinforce the anti-tobacco message in the community. Establishing the practical utility of newer lung function parameters can help to disseminate their utilization for early objective health information, which would provide incentives for healthcare professionals as well as individual smokers in the pursuance of smoking cessation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or above
  • Agreed to give informed written consent

排除标准

  • subjects refuse to give informed written consent
  • subjects with active infection or medical illness under treatment

结局指标

主要结局

Spirometry parameters

时间窗: Two years

1. FEV1 raw, 2. FEV1 % predicted 3. FEV1/FVC 4. FEV3 raw 5. FEV3/FVC 6. FEV1/FEV6

次要结局

  • Serum biomarkers(Two years)

研究者

申办方类型
Other

研究点 (1)

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