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

NCT02926534 | Completed

• 1 other identifier: IIS.PMI.2016.001
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

chronic obstructive pulmonary disease; smoking; prevalence; cross-sectional study; Kazakhstan

Outcome Measures

Primary Outcomes (1)

• Evidence of chronic obstructive pulmonary disease

  airflow obstruction based on the fixed ratio of post-bronchodilator FEV1 /FVC \< 0.70 criterion

  up to 1 week

Secondary Outcomes (8)

• Airflow obstruction through lung function test

  up to 1 week

• COPD CT score

  up to 2 weeks

• Results of 6-minute walking test

  up to 1 week

• COPD assessment test (CAT) score

  up to 1 week

• Comorbidities of COPD

  up to 1 week

Other Outcomes (2)

• 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

  up to 1 week

• Number of Participants With Positive or Negative Results of Testing for Anti-HCV and HBsAG

  up to 1 week

Study Arms (3)

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)

Eligibility Criteria

• Age: 35 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kazakhstan Academy of Preventive Medicine: lead
• Philip Morris International: collaborator
• Synergy Research Group: collaborator
• HealthCity LLP: collaborator

Study Sites (1)

Kazakhstan Academy of Preventive Medicine

Almaty, 050008, Kazakhstan

Location

Related Publications (1)

• 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.

  PMID: 28743683 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Almaz T Sharman, MD, PhD

  Kazakhstan Academy of Preventive Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 6, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 30, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

KA (1)