Chronic Airflow Obstruction Clinical Trial
Official title:
A Study on Smoking-related Lung Function Abnormalities and Correlation With Serum Biomarkers in Chinese
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
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.
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
Subjects In 2001 - 2003, we conducted a multi-center study to recruit 1089 non-smokers for
establishing local reference lung function values, and 694 smokers for investigating the
diagnostic definition of airflow obstruction. The cohort was derived from a random
population sample and the characteristics of the two cohorts have been described in detail
in previous communications. All subjects will be invited to return for spirometry testing.
We would compare their lung function parameters 7 years ago with the repeat measurements
obtained in this study.
Methods:
i. Subjects will be interviewed using a questionnaire based on the ATS Questionnaire for
Chronic Respiratory Symptoms. In addition, a detailed smoking history will be asked; for
those who have given up smoking in the interval between the previous study and this study,
the time of quitting will be recorded.
ii. Spirometry. Spirometry with bronchodilator testing will be performed according to the
ATS-ERS guidelines, using Sensormedics Vmax 229. All participating centers are experienced
in lung function testing. Quality control of the tests will be ensured by 1) standardization
and calibration of the equipments prior to commencement of study, 2) briefing session for
all involved technicians conducted by a senior technician, 3) technical quality of raw data
will be scrutinized by a respiratory specialist iii. Seum biomarkers Recruited subjects will
be invited to give 10 ml blood in the same lung function test session.
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Observational Model: Cohort, Time Perspective: Prospective