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
Condition: Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Physical Disability; Respiratory Disease
MeSH terms: Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Signs and Symptoms, Respiratory
Study type: Observational

Summary: 
      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: 
      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.
    

Intervention name(s): Heated Tobacco product IQOS/heatstick; Smoking combustible cigarettes
Intervention type(s): Other; Other
Intervention description(s): Heated Tobacco Products: heatsticks heated by iQOS device; Current smoking of combustible cigarettes
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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).
      
Biospecimen description: 
      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.
    
Keywords: COPD; Exacerbation of respiratory symptoms; Functional exercise capacity; Heated Tobacco Products; Respiratory symptoms