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| Name | Class |
|---|---|
| Philip Morris International | INDUSTRY |
| Synergy Research Group | INDUSTRY |
| HealthCity LLP | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Users of IQOS with HeatStick | Individuals (men and women) between the ages of 40 and 59 (inclusive) with a minimum of 10 pack-year smoking history who switched to and predominantly (>70%) use Heated Tobacco product IQOS/heatstick |
| |
| Smokers of combustible cigarettes | Individuals (men and women) between the ages of 40 and 59 (inclusive) who are currently smoking combustible cigarettes with a minimum of 10 pack-year smoking history |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heated Tobacco product IQOS/heatstick | Other | Heated Tobacco Products: heatsticks heated by iQOS device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of respiratory symptoms defined by CAT≥10 | The total COPD Assessment Test Scores 10 and more as an indicator of more symptoms | 5 years |
| Functional exercise incapacity | Less than 450 meters walked during the six-minute walk test | 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). | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of chronic obstructive pulmonary disease | Airflow obstruction based on the fixed ratio of post-bronchodilator FEV1 /FVC < 0.70 criterion | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women; Legally incapable individuals;
Patients with history of:
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Individuals aged 40 - 59 who live in City of Almaty and smoke combustible cigarettes (CC smokers - control group) or predominantly use IQOS with HeatStick (exposure group).
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| Name | Affiliation | Role |
|---|---|---|
| Almaz Sharman, MD, PhD | Kazakhstan Academy of Preventive Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kazakhstan Academy of Preventive Medicine | Almaty | 050008 | Kazakhstan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30401669 | Derived | Sharman A, Zhussupov B, Sharman D, Kim I, Yerenchina E. Lung Function in Users of a Smoke-Free Electronic Device With HeatSticks (iQOS) Versus Smokers of Conventional Cigarettes: Protocol for a Longitudinal Cohort Observational Study. JMIR Res Protoc. 2018 Nov 5;7(11):e10006. doi: 10.2196/10006. |
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The investigators will share all participant data except personally identifiable information. Data will be available to open-access after the completion of the study. Access to study data, which is going to be located in our web site, will be granted by request.
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Blood testing for: complete blood count (CBC), blood cholesterol level, HDL (highdensity lipoprotein), LDL (low-density lipoproteins), triglycerides, C-reactive protein, fibrinogen, glucose. Biomarker testing for sRAGE, ICAM1, CCL20 and probably other biomarkers.
| Smoking combustible cigarettes | Other | Current smoking of combustible cigarettes |
|
| 5 years |
| Clinical findings by physical pulmonary exam | Presence of any pathological findings during the pulmonary (percussion and inspection) exam | 5 years |
| Clinical findings by physical cardiac second sounds exams | Presence of any pathological findings during the cardiac second sounds exam | 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 | 5 years |
| Decreased Oxygen saturation | Percentage of hemoglobin loaded with oxygen (<95%) | 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. | 5 years |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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