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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by The University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01185652
First received: August 18, 2010
Last updated: May 12, 2011
Last verified: May 2011

August 18, 2010
May 12, 2011
May 2010
April 2012   (final data collection date for primary outcome measure)
Spirometry parameters [ Time Frame: Two years ] [ Designated as safety issue: No ]
  1. FEV1 raw,
  2. FEV1 % predicted
  3. FEV1/FVC
  4. FEV3 raw
  5. FEV3/FVC
  6. FEV1/FEV6
Same as current
Complete list of historical versions of study NCT01185652 on ClinicalTrials.gov Archive Site
Serum biomarkers [ Time Frame: Two years ] [ Designated as safety issue: No ]
Serum levels of IL-8, TGF-β, MMP9, TIMP-1, CRP
Same as current
Not Provided
Not Provided
 
A Study on Smoking-related Lung Function Abnormalities and Correlation With Serum Biomarkers in Chinese
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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

10 ml Peripheral blood will be collected upon recruitment for storage and later extraction of DNA and serum biomarkers

Non-Probability Sample

In 2001 - 2003, we conducted a 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 (at one of the participating hospitals of their choice) and an interview. We would compare their lung function parameters 7 years ago with the repeat measurements obtained in this study.

Chronic Airflow Obstruction
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
September 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • subjects refuse to give informed written consent
  • subjects with active infection or medical illness under treatment
Both
18 Years and older
No
Contact: David CL LAM, BSc,MBBS,MRCP,PhD,FCCP,FACP (852) 2255 5814 dcllam@hku.hk
Hong Kong
 
NCT01185652
HKCTR803
Yes
David Chi-leung LAM, University of Hong Kong
The University of Hong Kong
Not Provided
Principal Investigator: David CL Lam, BSc,MBBS,PhD,FCCP,FACP,FRCP(E) The University of Hong Kong
The University of Hong Kong
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP