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Cross-Sectional Study of COPD Prevalence Among Smokers, Ex-smokers and Never-Smokers in Almaty, Kazakhstan

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ClinicalTrials.gov Identifier: NCT02926534
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : October 30, 2017
Sponsor:
Collaborators:
Philip Morris International
Synergy Research Group Kazakhstan
HealthCity LLP
Information provided by (Responsible Party):
Kazakhstan Academy of Preventive Medicine

Brief 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 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.

Condition or disease
Chronic Obstructive Pulmonary Disease (COPD)

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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
Study Start Date : September 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort
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)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Airflow obstruction through lung function test [ Time Frame: up to 1 week ]
    Items to be analyzed are pre/post bronchodilator FEV1, FVC, FEV1/FVC

  2. COPD CT score [ Time Frame: up to 2 weeks ]
    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

  3. Results of 6-minute walking test [ Time Frame: up to 1 week ]
  4. COPD assessment test (CAT) score [ Time Frame: up to 1 week ]
  5. Comorbidities of COPD [ Time Frame: up to 1 week ]
  6. Presence of metabolic syndrome [ Time Frame: up to 1 week ]
    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

  7. 10 year risk of fatal CVD [ Time Frame: up to 1 week ]
    Systematic Coronary Risk Evaluation (SCORE) based on the European High Risk SCORE Chart by gender, age, systolic blood pressure, total cholesterol and smoking status

  8. Presence of an electrocardiogram abnormality [ Time Frame: up to 1 week ]
    Detection of abnormality during the electrocardiogram


Other Outcome Measures:
  1. 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 ]
    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

  2. Number of Participants With Positive or Negative Results of Testing for Anti-HCV and HBsAG [ Time Frame: up to 1 week ]

Biospecimen Retention:   Samples Without DNA
Serum


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926534


Locations
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Kazakhstan
Kazakhstan Academy of Preventive Medicine
Almaty, Kazakhstan, 050008
Sponsors and Collaborators
Kazakhstan Academy of Preventive Medicine
Philip Morris International
Synergy Research Group Kazakhstan
HealthCity LLP
Investigators
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Principal Investigator: Almaz T Sharman, MD, PhD Kazakhstan Academy of Preventive Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kazakhstan Academy of Preventive Medicine
ClinicalTrials.gov Identifier: NCT02926534     History of Changes
Other Study ID Numbers: IIS.PMI.2016.001
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Keywords provided by Kazakhstan Academy of Preventive Medicine:
chronic obstructive pulmonary disease
smoking
prevalence
cross-sectional study
Kazakhstan
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases