Сohort Study to Evaluate Exacerbations, Respiratory Symptoms, Physical Exercise Intolerance and Lung Functions Among Participants Who Use IQOS With Heatsticks Compared to Smokers of Conventional Cigarettes

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A 5-year Cohort Observational Study to Evaluate 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

Conditions
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Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency, Physical Disability, Respiratory Disease

Intervention / Treatment
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* Other: Heated Tobacco product IQOS/heatstick
* Other: Smoking combustible cigarettes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Age 40-59 years inclusive Smoking history ≥10 pack-years (for both cohorts) Ability to follow study procedures Exclusion Criteria: Pregnant women; Legally incapable individuals; Patients with history of: chronic infectious and non-infectious lung disease except asthma (e.g. pulmonary fibrosis, bronchiectasis, cystic fibrosis, tuberculosis, etc.) diagnosed prior to or during the first visit to KAPM COPD Center; previous surgical excision of at least one lung lobe (or having undergone a lung volume reduction procedure); active cancer of any localization under treatment; suspected cancer of any localization; metallic articles in the chest; recent eye surgery (during the last 6 month prior to the visit); episode (s) of myocardial infarction within less than 6 months prior to the visit or another form of acute or chronic coronary heart disease, history of heart rhythm abnormality with episode of arrhythmia within the last 6 months prior to the visit or long lasting that requires continuous drug therapy; acute episode of cerebrovascular ischemic attack within the last 12 month prior to the visit; chest or abdominal surgery performed within the last 6 month prior the visit; contraindications to salbutamol or refusal to inhale salbutamol; chest radiation therapy within the last 12 month prior to the visit; radiology diagnostic procedures of chest within the last 6 months prior to the visit; recent (6 weeks before the visit) respiratory tract infection (colds, flus), fever of any etiology with increasing temperature over 37 C at the time of the visit and in the last 2 weeks prior to the visit; significant history of alcohol abuse or consumption of more than recommended units of alcohol per week (28 units male and 21 units female); positive screening test for HIV antibodies or positive screening for TB, if available at the time of first visit; elevated blood pressure (systolic) is ≥160 mmHg at the moment of visit. PMI employees and first degree relatives

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Users of IQOS with HeatStick<br>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 | Other: Heated Tobacco product IQOS/heatstick<br>* Heated Tobacco Products: heatsticks heated by iQOS device<br>|
| Smokers of combustible cigarettes<br>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 | Other: Smoking combustible cigarettes<br>* Current smoking of combustible cigarettes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional exercise capacity, COPD, Exacerbation of respiratory symptoms, Heated Tobacco Products, Respiratory symptoms