Chronic Obstructive Pulmonary Disease (COPD)NCT02926534
Cross-Sectional Study of COPD Prevalence Among Smokers, Ex-smokers and Never-Smokers in Almaty, Kazakhstan
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Kazakhstan Academy of Preventive Medicine at 1 site in Kazakhstan.
Trial summary
The purpose of this study is to assess the prevalence of COPD among individuals aged 35 - 59 years based results of spirometry before and after bronchodilator, presence of structural changes in lungs (emphysema, inflammatory changes and thickening of the walls of the large and small airways)detected by computer… Read more about this study
- Who is it for?
- Ages 35 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 900 participants
- Where
- 1 siteKazakhstan
- Study dates
- Sep 2016to May 2017
- 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 35 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population is three groups of male and female residents of City of Almaty, the largest city in Kazakhstan, with a population of 1,7 million people, containing 9% of the country's total population aged 33-59. The first group is current smokers with more than 10 pack-year history of smoking. The second group is individuals who quitted smoking from one to five years ago and have more than 10 pack-year history of smoking. The third group is persons who has never smoked regularly, i.e. smoked less than 100 cigarettes in his or her lifetime.
Who may be able to join
- ≥10 pack-year smoking history (for smokers and ex-smokers)
- less than 100 cigarettes in lifetime (for never-smokers)
- be able to provide informed consent
Who cannot join
- be pregnant
- has a fever (370C or higher) at the time of the visit and during the last two weeks preceding the visit
- be legally incapable
- chronic infectious and non-infectious lung disease except asthma (eg, pulmonary fibrosis, bronchiectasis, cystic fibrosis, tuberculosis, and others.)
- resection of at least one lobe (or performing procedures to reduce lung volume)
- any cancer and receiving a course of radiation and/or chemotherapy at the time of the visit;
Show all 16Show fewer
- suspected lung cancer (presence of significant lung neoplasm)
- presence of metal in the chest
- ophthalmic surgery within the last 12 months prior to the visit
- myocardial infarction or other form of acute or chronic coronary insufficiency, cardiac arrhythmias diagnosed of at least 6 months prior to the visit
- myocardial infarction or other form of acute or chronic coronary insufficiency, cardiac arrhythmias with which an individual regularly receives medication
- Severely elevated blood pressure (equal to or greater than a systolic 180 or diastolic of 100)
- history of cerebrovascular accidents
- thoracic or abdominal surgery within the last 6 months
- contraindications to use salbutamol or its analogues
- CT scan or other research using ionizing radiation within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross-sectional Study of the Socio-demographic and Other Determinants of Chronic Obstructive Pulmonary Disease (COPD) Among Those Who Smoke, Quit Smoking and Never-smoking Cigarettes
The purpose of this study is to assess the prevalence of COPD among individuals aged 35 - 59 years based results of spirometry before and after bronchodilator, presence of structural changes in lungs (emphysema, inflammatory changes and thickening of the walls of the large and small airways)detected by computer tomography as well as the symptoms of COPD. The study has three study groups: smokers of conventional cigarettes; those who had quit smoking 1 - 5 years ago, and those who haven't smoked cigarettes.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death worldwide. An estimated 0.5 million individuals in Kazakhstan may be affected by COPD, and the number of affected individuals and of deaths from COPD are expected to increase as the population ages. A better understanding of the epidemiology, causes, and social and other determinants of the disease is needed in order to develop effective treatments and prevention strategies.
Although COPD is traditionally defined by airflow obstruction in a spirometry test, smoking-associated effects on the lungs related to COPD also include emphysema, gas trapping, and chronic bronchitis. Symptoms such as productive cough, dyspnea, and exercise intolerance may be dismissed as normal aging, especially in older former smokers. Information is sparse about effects of smoking on individuals not diagnosed as having COPD (based on spirometry), and data from high-resolution computed tomography (CT) scanning in these individuals are limited.
COPD is strongly associated with smoking, but not all smokers will develop COPD. Cigarette smoking continues to be a common addiction in Kazakhstan despite efforts to reduce its prevalence. The study objectives are to assess true prevalence of COPD based on pulmonary function assessment and structural changes (emphysema and large and small airway inflammation with thickening) identified by high-resolution computer tomography (CT-scan) in addition to standard spirometric criteria and symptoms of dyspnea, exercise limitations, and chronic bronchitis. Such comprehensive approach will allow for objective comparisons of (1) current smokers of conventional cigarettes - 500 participants, (2) those subjects who quit smoking within the past 1 - 5 years - 200 participants, and (3) those subjects who never smoked cigarettes - 200 participants.
Using high resolution CT in addition to spirometry and other types of lung function assessment will help to determine COPD prevalence among non-smokers, smokers of conventional cigarettes and those who quit smoking. COPD prevalence will be defined based on abnormal respiratory function assessed by standard spirometric tests and by using COPD assessment test (CAT) questionnaire, 6-minute walk test and a high-resolution computed tomographic (HRCT) scan of the chest of those patients with preserved pulmonary functions but with clinical symptoms.
The cross-sectional study is retrospective in a sense, as it will allow to collect historical data on smoking, smoking cessation, address socio-demographic and other differentials of smoking. The investigators will also address the relationship of liver disease with COPD. This will be determined based on presence of hepatitis B and C tests (antigens and antibodies), liver enzyme levels and concentration of alpha-1-antitripsine, which is related to the development of COPD. Current or former smokers who had a concomitant diagnosis of asthma will not be excluded in the cross-sectional study. Instead, historical data on whether the participant had been diagnosed with asthma will be collected.
The cross-sectional study has several study groups based on the exposure (smoking behavior) status. Combinations of paired associations are as follows: smokers vs. never-smokers; smokers vs. ex-smokers; never-smokers vs. ex-smokers. Therefore, it bears some feature of a retrospective cohort study, specifically; it provides an opportunity to make comparisons between the groups. While calculating the required sample size, the investigators considered this opportunity as the most important one. In addition to calculating prevalence ratio of COPD for exposure statuses, the cross-sectional study will allow for assessment of prevalence of these conditions and other characteristics in different study groups.
Data to be collected
- Spirometry (FEV / FVC), bronchodilation test
- COPD assessment test (CAT) questionnaire,
- 6-minute walk test
- Electrocardiography
- High-resolution computed tomographic (HRCT) scan of the chest
- Blood pressure
- Body mass index (BMI)
- Smoking status and history
- Passive smoking status
- Occupational exposure
- Exposure to indoor biofuel pollution
- Patient-reported comorbidities
- Laboratory testing for: blood cholesterol level, HDL (high-density lipoprotein), LDL (low-density lipoproteins), triglycerides, C-reactive protein, fibrinogen, glucose, Hepatitis B and C IgM and IgG antigens and antibodies, liver enzymes (ALT and AST), and alpha-1-antitrypsine.
The investigators plan to recruit subjects by using the following mechanisms, namely, through social media, a network of medical referral sites (polyclinics and ambulatory centers), and from large corporations, i.e. with more than 500 employees.
Information about current smoking behavior and very detailed historic information on smoking behavior will be used to for adjustments during the data analysis phase.
- Keywords
- chronic obstructive pulmonary disease, smoking, prevalence, cross-sectional study, Kazakhstan
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Individuals (men and women) between the ages of 35 and 59 (inclusive) who are currently smoking conventional cigarettes with a minimum of 10 pack-year smoking history | |
| Ex-smokers | Individuals (men and women) between the ages of 35 and 59 (inclusive) with a minimum of 10 pack-year smoking history who stopped smoking cigarettes between 1 and 5 years ago | |
| Never-smokers | Individuals (men and women) between the ages of 35 and 59 (inclusive) who are current non-smokers and with no history of smoking (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of chronic obstructive pulmonary disease
airflow obstruction based on the fixed ratio of post-bronchodilator FEV1 /FVC < 0.70 criterion
Measured: up to 1 week
Secondary outcomes (8)
Airflow obstruction through lung function test
Items to be analyzed are pre/post bronchodilator FEV1, FVC, FEV1/FVC
Measured: up to 1 week
COPD CT score
Semi-quantified measures performed by three CT scan readers to evaluate extent of emphysema, severity of bronchial dilatation, traction bronchiectasis, bronchial wall thickening, small airways disease
Measured: up to 2 weeks
Results of 6-minute walking test
Measured: up to 1 week
COPD assessment test (CAT) score
Measured: up to 1 week
Comorbidities of COPD
Measured: up to 1 week
Presence of metabolic syndrome
Detection of metabolic syndrome based on the new International Diabetes Federation (IDF) definition that includes central obesity AND any two of the following factors: raised TG level; reduced HDL cholesterol; raised blood pressure; raised fasting plasma glucose
Measured: up to 1 week
10 year risk of fatal CVD
Systematic Coronary Risk Evaluation (SCORE) based on the European High Risk SCORE Chart by gender, age, systolic blood pressure, total cholesterol and smoking status
Measured: up to 1 week
Presence of an electrocardiogram abnormality
Detection of abnormality during the electrocardiogram
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2017
- Study completionMay 2017
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 Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kazakhstan Academy of Preventive Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Philip Morris International, Synergy Research Group, HealthCity LLP
- Responsible party
- Sponsor
- Investigators
- Almaz T Sharman, MD, PhD, Principal investigator, Kazakhstan Academy of Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926534
- Sponsor's protocol ID
- IIS.PMI.2016.001
- Status last verified
- Oct 2017
- First submitted
- 3 Oct 2016
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The investigators will share all participant data except personally identifiable information. Data will be available to open-access after the completion of the study (after July 31, 2017). Access to study data, which is going to be located in our web site, will be granted by request.
Publications
Sharman A, Zhussupov B, Sharman D, Stambekova A, Yeraliyev S. Cross-Sectional Study of Chronic Obstructive Pulmonary Disease Prevalence Among Smokers, Ex-Smokers, and Never-Smokers in Almaty, Kazakhstan: Study Protocol. JMIR Res Protoc. 2017 Jul 25;6(7):e143. doi: 10.2196/resprot.7422.
PubMed 28743683
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study of the Socio-demographic and Other Determinants of Chronic Obstructive Pulmonary Disease (COPD) Among Those Who Smoke, Quit Smoking and Never-smoking Cigarettes
- ClinicalTrials.gov ID
- NCT02926534
- Acronym / sponsor ID
- IIS.PMI.2016.001
- Keywords
- chronic obstructive pulmonary disease, smoking, prevalence, cross-sectional study, Kazakhstan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Kazakhstan Academy of Preventive MedicineUniversity, hospital or other
- Collaborators
- Philip Morris International, Synergy Research Group, HealthCity LLP
- Study start
- Sep 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 6 Oct 2016 (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.
The purpose of this study is to assess the prevalence of COPD among individuals aged 35 - 59 years based results of spirometry before and after bronchodilator, presence of structural changes in lungs (emphysema, inflammatory changes and thickening of the walls of the large and small airways)detected by computer tomography as well as the symptoms of COPD. The study has three study groups: smokers of conventional cigarettes; those who had quit smoking 1 - 5 years ago, and those who haven't smoked cigarettes.
Detailed description
Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death worldwide. An estimated 0.5 million individuals in Kazakhstan may be affected by COPD, and the number of affected individuals and of deaths from COPD are expected to increase as the population ages. A better understanding of the epidemiology, causes, and social and other determinants of the disease is needed in order to develop effective treatments and prevention strategies.
Although COPD is traditionally defined by airflow obstruction in a spirometry test, smoking-associated effects on the lungs related to COPD also include emphysema, gas trapping, and chronic bronchitis. Symptoms such as productive cough, dyspnea, and exercise intolerance may be dismissed as normal aging, especially in older former smokers. Information is sparse about effects of smoking on individuals not diagnosed as having COPD (based on spirometry), and data from high-resolution computed tomography (CT) scanning in these individuals are limited.
COPD is strongly associated with smoking, but not all smokers will develop COPD. Cigarette smoking continues to be a common addiction in Kazakhstan despite efforts to reduce its prevalence. The study objectives are to assess true prevalence of COPD based on pulmonary function assessment and structural changes (emphysema and large and small airway inflammation with thickening) identified by high-resolution computer tomography (CT-scan) in addition to standard spirometric criteria and symptoms of dyspnea, exercise limitations, and chronic bronchitis. Such comprehensive approach will allow for objective comparisons of (1) current smokers of conventional cigarettes - 500 participants, (2) those subjects who quit smoking within the past 1 - 5 years - 200 participants, and (3) those subjects who never smoked cigarettes - 200 participants.
Using high resolution CT in addition to spirometry and other types of lung function assessment will help to determine COPD prevalence among non-smokers, smokers of conventional cigarettes and those who quit smoking. COPD prevalence will be defined based on abnormal respiratory function assessed by standard spirometric tests and by using COPD assessment test (CAT) questionnaire, 6-minute walk test and a high-resolution computed tomographic (HRCT) scan of the chest of those patients with preserved pulmonary functions but with clinical symptoms.
The cross-sectional study is retrospective in a sense, as it will allow to collect historical data on smoking, smoking cessation, address socio-demographic and other differentials of smoking. The investigators will also address the relationship of liver disease with COPD. This will be determined based on presence of hepatitis B and C tests (antigens and antibodies), liver enzyme levels and concentration of alpha-1-antitripsine, which is related to the development of COPD. Current or former smokers who had a concomitant diagnosis of asthma will not be excluded in the cross-sectional study. Instead, historical data on whether the participant had been diagnosed with asthma will be collected.
The cross-sectional study has several study groups based on the exposure (smoking behavior) status. Combinations of paired associations are as follows: smokers vs. never-smokers; smokers vs. ex-smokers; never-smokers vs. ex-smokers. Therefore, it bears some feature of a retrospective cohort study, specifically; it provides an opportunity to make comparisons between the groups. While calculating the required sample size, the investigators considered this opportunity as the most important one. In addition to calculating prevalence ratio of COPD for exposure statuses, the cross-sectional study will allow for assessment of prevalence of these conditions and other characteristics in different study groups.
Data to be collected
- Spirometry (FEV / FVC), bronchodilation test
- COPD assessment test (CAT) questionnaire,
- 6-minute walk test
- Electrocardiography
- High-resolution computed tomographic (HRCT) scan of the chest
- Blood pressure
- Body mass index (BMI)
- Smoking status and history
- Passive smoking status
- Occupational exposure
- Exposure to indoor biofuel pollution
- Patient-reported comorbidities
- Laboratory testing for: blood cholesterol level, HDL (high-density lipoprotein), LDL (low-density lipoproteins), triglycerides, C-reactive protein, fibrinogen, glucose, Hepatitis B and C IgM and IgG antigens and antibodies, liver enzymes (ALT and AST), and alpha-1-antitrypsine.
The investigators plan to recruit subjects by using the following mechanisms, namely, through social media, a network of medical referral sites (polyclinics and ambulatory centers), and from large corporations, i.e. with more than 500 employees.
Information about current smoking behavior and very detailed historic information on smoking behavior will be used to for adjustments during the data analysis phase.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smokers | – | –Individuals (men and women) between the ages of 35 and 59 (inclusive) who are currently smoking conventional cigarettes with a minimum of 10 pack-year smoking history |
| Ex-smokers | – | –Individuals (men and women) between the ages of 35 and 59 (inclusive) with a minimum of 10 pack-year smoking history who stopped smoking cigarettes between 1 and 5 years ago |
| Never-smokers | – | –Individuals (men and women) between the ages of 35 and 59 (inclusive) who are current non-smokers and with no history of smoking (control group) |
Who may qualify
- Ages
- 35 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population is three groups of male and female residents of City of Almaty, the largest city in Kazakhstan, with a population of 1,7 million people, containing 9% of the country's total population aged 33-59. The first group is current smokers with more than 10 pack-year history of smoking. The second group is individuals who quitted smoking from one to five years ago and have more than 10 pack-year history of smoking. The third group is persons who has never smoked regularly, i.e. smoked less than 100 cigarettes in his or her lifetime.
Key inclusion criteria (3 listed)
- ≥10 pack-year smoking history (for smokers and ex-smokers)
- less than 100 cigarettes in lifetime (for never-smokers)
- be able to provide informed consent
Key exclusion criteria (16 listed)
- be pregnant
- has a fever (370C or higher) at the time of the visit and during the last two weeks preceding the visit
- be legally incapable
- chronic infectious and non-infectious lung disease except asthma (eg, pulmonary fibrosis, bronchiectasis, cystic fibrosis, tuberculosis, and others.)
- resection of at least one lobe (or performing procedures to reduce lung volume)
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
Evidence of chronic obstructive pulmonary disease
Time frame: up to 1 week
airflow obstruction based on the fixed ratio of post-bronchodilator FEV1 /FVC < 0.70 criterion
8 secondary outcomes
Airflow obstruction through lung function test
Time frame: up to 1 week
COPD CT score
Time frame: up to 2 weeks
Results of 6-minute walking test
Time frame: up to 1 week
COPD assessment test (CAT) score
Time frame: up to 1 week
Comorbidities of COPD
Time frame: up to 1 week
Presence of metabolic syndrome
Time frame: up to 1 week
10 year risk of fatal CVD
Time frame: up to 1 week
Presence of an electrocardiogram abnormality
Time frame: up to 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Derived from this study: PubMed 28743683Sharman A, Zhussupov B, Sharman D, Stambekova A, Yeraliyev S. Cross-Sectional Study of Chronic Obstructive Pulmonary Disease Prevalence Among Smokers, Ex-Smokers, and Never-Smokers in Almaty, Kazakhstan: Study Protocol. JMIR Res Protoc. 2017 Jul 25;6(7):e143. doi: 10.2196/resprot.7422.
- Individual participant dataSharing planned: Yes. The investigators will share all participant data except personally identifiable information. Data will be available to open-access after the completion of the study (after July 31, 2017). Access to study data, which is going to be located in our web site, will be granted by request.
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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.
Almaz T Sharman, MD, PhD principal investigator
Kazakhstan Academy of Preventive Medicine
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 Obstructive Pulmonary Disease (COPD), run by Kazakhstan Academy of Preventive Medicine at 1 site in Kazakhstan.
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 3 inclusion and 16 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: finished, as of the sponsor's last update on 30 Oct 2017. 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 Kazakhstan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of chronic obstructive pulmonary disease (time frame: up to 1 week). 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 NCT02926534, 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 30 Oct 2017.