This study evaluates frequency of exacerbations, respiratory symptoms, physical exercise intolerance and abnormal lung functions among participants who use IQOS with heatsticks compared to smokers of conventional cigarettes
Heated Tobacco Products, such as Heatsticks heated by iQOS device, are specially designed tobacco products that contain tobacco material and several filter sections. Recent studies demonstrate that the vapor from Heatsticks heated by iQOS device contains 90 to 95% less harmful and potentially harmful compounds ("HPHCs") and is 90 to 95% less toxic than the smoke of a reference combustible cigarette. IQOS with HeatSticks may serve as less risky alternatives to combustible cigarettes and to other traditional tobacco products in clinical setting. The investigators hypothesize that participants using IQOS with HeatSticks will have less prevalent presence of respiratory symptoms, have better functional exercise capacity, and experience less exacerbations compared to those who smoke combustible cigarettes by demonstrating whether the trends of the response variables across time is the same between the exposure and the control groups. This 5-years observational study includes two cohorts of participants age 40 - 59: (1) smokers of combustible cigarettes (CC smokers -control group) and (2) users of IQOS with HeatStick (exposure group). The study has baseline and periodic (annual) comprehensive clinical assessments, as well as continuous COPD case-finding activities and registering acute exacerbations of COPD.
Study Type
OBSERVATIONAL
Enrollment
1,200
Heated Tobacco Products: heatsticks heated by iQOS device
Current smoking of combustible cigarettes
Kazakhstan Academy of Preventive Medicine
Almaty, Kazakhstan
Presence of respiratory symptoms defined by CAT≥10
The total COPD Assessment Test Scores 10 and more as an indicator of more symptoms
Time frame: 5 years
Functional exercise incapacity
Less than 450 meters walked during the six-minute walk test
Time frame: 5 years
Respiratory exacerbations
A worsening of respiratory symptoms, which required treatment with oral corticosteroids or antibiotics, or both or a health care utilization event (office visit, hospital admission, or emergency department visit for a respiratory flare-up).
Time frame: 5 years
Evidence of chronic obstructive pulmonary disease
Airflow obstruction based on the fixed ratio of post-bronchodilator FEV1 /FVC \< 0.70 criterion
Time frame: 5 years
ECG abnormalities
Presence of any ECG abnormalities including pathologic q-waves, ST elevation, ST depression, T-wave inversion, hypertrophy, QRS axis deviation, block, arrhythmia.
Time frame: 5 years
Clinical findings by physical pulmonary exam
Presence of any pathological findings during the pulmonary (percussion and inspection) exam
Time frame: 5 years
Clinical findings by physical cardiac second sounds exams
Presence of any pathological findings during the cardiac second sounds exam
Time frame: 5 years
Metabolic syndrome
Presence of metabolic syndrome based on the IDF definition: Central obesity (defined as waist circumference with ethnicity specific values) PLUS any two of the following four factors: raised triglycerides; reduced HDL cholesterol; raised blood pressure; raised fasting plasma glucose
Time frame: 5 years
Decreased Oxygen saturation
Percentage of hemoglobin loaded with oxygen (\<95%)
Time frame: 5 years
Low Dose Computerised Tomography (LDCT) of the Chest Features
Grading the severity of the following: bronchiectasis, bronchial wall thickening, emphysema, reticular pattern or honeycombing.
Time frame: 5 years
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