Chronic Airflow ObstructionNCT01185652
A Study on Smoking-related Lung Function Abnormalities and Correlation With Serum Biomarkers in Chinese
An observational study of Chronic Airflow Obstruction, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Airflow Obstruction
- How many people
- 1,000 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2010to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age 18 or above
- Agreed to give informed written consent
Who cannot join
- subjects refuse to give informed written consent
- subjects with active infection or medical illness under treatment
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
University of Hong Kong Queen Mary Hospital
Hong Kong, Hong Kong, 0
David CL Lam, BSc,MBBS,PhD,FCCP,FACP,FRCP(E), (852) 2255 5814, dcllam@hku.hk
David CL Lam, BSc,MBBS,PhD,FCCP,FACP,FRCP(E)
About this study
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:
Read more
- to evaluate and compare lung function decline in persistent smokers and non-smokers
- to study the usefulness of FEV3/FVC and FEV1/FEV6 in detecting lung function decline
- to correlate symptom scores with lung function parameters
- 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:
- smokers have significantly greater decline in lung function compared to non-smokers in Hong Kong Chinese;
- newer lung function parameters are useful alternatives in detecting lung function decline
- 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
Read the detailed description
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:
- to evaluate and compare lung function decline in persistent smokers and non-smokers
- to study the usefulness of FEV3/FVC and FEV1/FEV6 in detecting lung function decline
- to correlate symptom scores with lung function parameters
- 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:
- smokers have significantly greater decline in lung function compared to non-smokers in Hong Kong Chinese;
- newer lung function parameters are useful alternatives in detecting lung function decline
- 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:
- 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.
- Conditions
- Chronic Airflow Obstruction
- Keywords
- Smoking, airflow obstruction, pulmonary function tests
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Smoking
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometry parameters
- FEV1 raw,
- FEV1 % predicted
- FEV1/FVC
- FEV3 raw
- FEV3/FVC
- FEV1/FEV6
Measured: Two years
Secondary outcomes (1)
Serum biomarkers
Serum levels of IL-8, TGF-β, MMP9, TIMP-1, CRP
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Airflow ObstructionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- David CL Lam, BSc,MBBS,PhD,FCCP,FACP,FRCP(E), Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185652
- Sponsor's protocol ID
- HKCTR803
- Status last verified
- May 2011
- First submitted
- 18 Aug 2010
- Last updated
- 13 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lam DC, Kwok HH, Yu WC, Ko FW, Tam CY, Lau AC, Fong DY, Ip MS. CC16 levels correlate with cigarette smoke exposure in bronchial epithelial cells and with lung function decline in smokers. BMC Pulm Med. 2018 Mar 16;18(1):47. doi: 10.1186/s12890-018-0607-7.
PubMed 29548305
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Smoking-related Lung Function Abnormalities and Correlation With Serum Biomarkers in Chinese
- ClinicalTrials.gov ID
- NCT01185652
- Acronym / sponsor ID
- HKCTR803
- Conditions
- Chronic Airflow Obstruction
- Keywords
- Smoking, airflow obstruction, pulmonary function tests
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 20 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to evaluate and compare lung function decline in persistent smokers and non-smokers
- to study the usefulness of FEV3/FVC and FEV1/FEV6 in detecting lung function decline
- to correlate symptom scores with lung function parameters
- 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:
- smokers have significantly greater decline in lung function compared to non-smokers in Hong Kong Chinese;
- newer lung function parameters are useful alternatives in detecting lung function decline
- 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
Detailed description
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:
- to evaluate and compare lung function decline in persistent smokers and non-smokers
- to study the usefulness of FEV3/FVC and FEV1/FEV6 in detecting lung function decline
- to correlate symptom scores with lung function parameters
- 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:
- smokers have significantly greater decline in lung function compared to non-smokers in Hong Kong Chinese;
- newer lung function parameters are useful alternatives in detecting lung function decline
- 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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Age 18 or above
- Agreed to give informed written consent
Key exclusion criteria (2 listed)
- subjects refuse to give informed written consent
- subjects with active infection or medical illness under treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spirometry parameters
Time frame: Two years
1. FEV1 raw, 2. FEV1 % predicted 3. FEV1/FVC 4. FEV3 raw 5. FEV3/FVC 6. FEV1/FEV6
1 secondary outcome
Serum biomarkers
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2011.
- Derived from this study: PubMed 29548305Lam DC, Kwok HH, Yu WC, Ko FW, Tam CY, Lau AC, Fong DY, Ip MS. CC16 levels correlate with cigarette smoke exposure in bronchial epithelial cells and with lung function decline in smokers. BMC Pulm Med. 2018 Mar 16;18(1):47. doi: 10.1186/s12890-018-0607-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David CL Lam, BSc,MBBS,PhD,FCCP,FACP,FRCP(E) principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Airflow Obstruction, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David CL LAM, BSc,MBBS,MRCP,PhD,FCCP,FACP ((852) 2255 5814, dcllam@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spirometry parameters (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01185652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2011.