- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02926534
Cross-Sectional Study of COPD Prevalence Among Smokers, Ex-smokers and Never-Smokers in Almaty, Kazakhstan
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
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Almaty, Kazakhstan, 050008
- Kazakhstan Academy of Preventive Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥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
Exclusion Criteria:
- 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;
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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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
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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
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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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evidence of chronic obstructive pulmonary disease
Time Frame: up to 1 week
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airflow obstruction based on the fixed ratio of post-bronchodilator FEV1 /FVC < 0.70 criterion
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up to 1 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Airflow obstruction through lung function test
Time Frame: up to 1 week
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Items to be analyzed are pre/post bronchodilator FEV1, FVC, FEV1/FVC
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up to 1 week
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COPD CT score
Time Frame: up to 2 weeks
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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
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up to 2 weeks
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Results of 6-minute walking test
Time Frame: up to 1 week
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up to 1 week
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COPD assessment test (CAT) score
Time Frame: up to 1 week
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up to 1 week
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Comorbidities of COPD
Time Frame: up to 1 week
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up to 1 week
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Presence of metabolic syndrome
Time Frame: up to 1 week
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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
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up to 1 week
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10 year risk of fatal CVD
Time Frame: up to 1 week
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Systematic Coronary Risk Evaluation (SCORE) based on the European High Risk SCORE Chart by gender, age, systolic blood pressure, total cholesterol and smoking status
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up to 1 week
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Presence of an electrocardiogram abnormality
Time Frame: up to 1 week
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Detection of abnormality during the electrocardiogram
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up to 1 week
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentrations of total cholesterol, low density lipoprotein (LDL) cholesterol, HDL cholesterol, triglyceride (TG), glucose, liver enzymes (ALT and AST), C-reactive protein, fibrinogen, and alpha-1-antitrypsin
Time Frame: up to 1 week
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Serum laboratory testing for blood cholesterol level, HDL (high-density lipoprotein), LDL (low-density lipoproteins), triglycerides, C-reactive protein, fibrinogen, glucose, liver enzymes (ALT and AST), and alpha-1-antitrypsin
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up to 1 week
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Number of Participants With Positive or Negative Results of Testing for Anti-HCV and HBsAG
Time Frame: up to 1 week
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up to 1 week
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Collaborators and Investigators
Investigators
- Principal Investigator: Almaz T Sharman, MD, PhD, Kazakhstan Academy of Preventive Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIS.PMI.2016.001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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