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

Almaz Sharman, Baurzhan Zhussupov, Dana Sharman, Irina Kim, Elmira Yerenchina, Almaz Sharman, Baurzhan Zhussupov, Dana Sharman, Irina Kim, Elmira Yerenchina

Abstract

Background: Chronic obstructive pulmonary disease (COPD) is a global public health problem. It is the third-leading cause of death in the world, the fourth leading cause of death in Kazakhstan, and is strongly associated with smoking. Smoking cessation reduces the severity of respiratory symptoms and COPD exacerbations. Heated tobacco products, such as HeatSticks heated by the iQOS device, a smoke-free electronic device, may serve as less risky alternatives to conventional combustible cigarettes.

Objective: The purpose of this study is to evaluate frequency of exacerbations, respiratory symptoms, physical exercise intolerance, and abnormal lung functions, as well as other parameters and comorbidities among men and women aged 40-59 residing in Almaty, Kazakhstan, who use iQOS with HeatSticks compared to smokers of conventional cigarettes.

Methods: This is a 5-year single-center cohort observational study. It includes two cohorts of participants consisting of men and women aged 40-59 residing in the city of Almaty, Kazakhstan: (1) smokers of combustible cigarettes (control group) and (2) users of iQOS with HeatSticks (exposure group). The study has baseline and periodic (ie, annual) comprehensive clinical assessments, as well as continuous COPD case-finding activities and registration of acute respiratory exacerbations over the course of the 5-year observation period. Study measures include spirometry, chest computed tomography, electrocardiography, physical exams, laboratory testing of serum for biomarkers of inflammation and metabolic syndrome, anthropometry, and the 6-minute walk test. Information about COPD symptoms will be collected using the COPD Assessment Test.

Results: Participant recruitment began December 2017, and enrollment is expected to last until late summer 2018.

Conclusions: This is the first cohort observational study in Kazakhstan to assess differences in lung function between users of the heated tobacco product, iQOS with HeatSticks, and smokers of conventional combustible cigarettes. The study results will add to knowledge on whether switching from combustible cigarettes to iQOS with HeatSticks affects respiratory symptoms and diseases, including the development and progression of COPD.

Trial registration: ClinicalTrials.gov NCT03383601; https://ichgcp.net/clinical-trials-registry/NCT03383601 (Archived by WebCite at http://www.webcitation.org/72BYoAKxa).

International registered report identifier (irrid): PRR1-10.2196/10006.

Keywords: COPD; COPD assessment test; CT scan; exacerbations; iQOS with HeatSticks; respiratory symptoms.

Conflict of interest statement

Conflicts of Interest: None declared.

©Almaz Sharman, Baurzhan Zhussupov, Dana Sharman, Irina Kim, Elmira Yerenchina. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 05.11.2018.

References

    1. GBD 2015 Mortality and Causes of Death Collaborators Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for 249 causes of death, 1980-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 08;388(10053):1459–1544. doi: 10.1016/S0140-6736(16)31012-1.
    1. Adeloye D, Chua S, Lee C, Basquill C, Papana A, Theodoratou E, Nair H, Gasevic D, Sridhar D, Campbell H, Chan KY, Sheikh A, Rudan I, Global Health Epidemiology Reference Group (GHERG) Global and regional estimates of COPD prevalence: Systematic review and meta-analysis. J Glob Health. 2015 Dec;5(2):020415. doi: 10.7189/jogh.05-020415.
    1. Vogelmeier C, Criner G, Martinez F, Anzueto A, Barnes P, Bourbeau J, Celli B, Chen R, Decramer M, Fabbri L, Frith Peter, Halpin DMG, López VMV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agustí A. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report. GOLD Executive Summary. Am J Respir Crit Care Med. 2017 Dec 01;195(5):557–582. doi: 10.1164/rccm.201701-0218PP.
    1. Shah T, Churpek MM, Coca PM, Konetzka RT. Understanding why patients with COPD get readmitted: a large national study to delineate the Medicare population for the readmissions penalty expansion. Chest. 2015 May;147(5):1219–1226. doi: 10.1378/chest.14-2181.
    1. GBD 2015 Chronic Respiratory Disease Collaborators Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Respir Med. 2017 Sep;5(9):691–706. doi: 10.1016/S2213-2600(17)30293-X.
    1. MacNee W. Pathology, pathogenesis, and pathophysiology. BMJ. 2006 May 18;332(7551):1202–1204. doi: 10.1136/bmj.332.7551.1202.
    1. Global Initiative for Chronic Obstructive Lung Disease. 2017. Global Strategy for the Diagnosis, Management and Prevention of COPD
    1. Qaseem A, Wilt TJ, Weinberger SE, Hanania NA, Criner G, van der Molen T, Marciniuk DD, Denberg T, Schünemann Holger, Wedzicha W, MacDonald R, Shekelle P, American College of Physicians. American College of Chest Physicians. American Thoracic Society. European Respiratory Society Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011 Aug 02;155(3):179–191. doi: 10.7326/0003-4819-155-3-201108020-00008.
    1. Cebron LN, Beijers RJHCG, van der Bost B, Doehner W, Lainscak M, Schols AMWJ. The Prevalence of Metabolic Syndrome In Chronic Obstructive Pulmonary Disease: A Systematic Review. COPD. 2016 Dec;13(3):399–406. doi: 10.3109/15412555.2016.1140732.
    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.
    1. Woodruff PG, Barr RG, Bleecker E, Christenson SA, Couper D, Curtis JL, Gouskova NA, Hansel NN, Hoffman EA, Kanner RE, Kleerup E, Lazarus SC, Martinez FJ, Paine R, Rennard S, Tashkin DP, Han MK, SPIROMICS Research Group Clinical Significance of Symptoms in Smokers with Preserved Pulmonary Function. N Engl J Med. 2016 May 12;374(19):1811–1821. doi: 10.1056/NEJMoa1505971.
    1. Regan EA, Lynch DA, Curran-Everett D, Curtis JL, Austin JHM, Grenier PA, Kauczor H, Bailey WC, DeMeo DL, Casaburi RH, Friedman P, Van Beek EJR, Hokanson JE, Bowler RP, Beaty TH, Washko GR, Han MK, Kim V, Kim SS, Yagihashi K, Washington L, McEvoy CE, Tanner C, Mannino DM, Make BJ, Silverman EK, Crapo JD, Genetic Epidemiology of COPD (COPDGene) Investigators Clinical and Radiologic Disease in Smokers With Normal Spirometry. JAMA Intern Med. 2015 Sep;175(9):1539–1549. doi: 10.1001/jamainternmed.2015.2735.
    1. Fletcher C, Peto R. The natural history of chronic airflow obstruction. Br Med J. 1977 Jun 25;1(6077):1645–1648.
    1. Haziza C, de la Bourdonnaye G, Merlet S, Benzimra M, Ancerewicz J, Donelli A, Baker G, Picavet P, Lüdicke Frank. Assessment of the reduction in levels of exposure to harmful and potentially harmful constituents in Japanese subjects using a novel tobacco heating system compared with conventional cigarettes and smoking abstinence: A randomized controlled study in confinement. Regul Toxicol Pharmacol. 2016 Nov;81:489–499. doi: 10.1016/j.yrtph.2016.09.014.
    1. Polosa R, Morjaria JB, Caponnetto P, Prosperini U, Russo C, Pennisi A, Bruno CM. Evidence for harm reduction in COPD smokers who switch to electronic cigarettes. Respir Res. 2016 Dec 16;17(1):166. doi: 10.1186/s12931-016-0481-x.
    1. : Manage Your Health.
    1. Medintel.
    1. Global Initiative for Chronic Obstructive Lung Disease Global Initiative for Chronic Obstructive Lung Disease. [2018-09-17]. Pocket guide to COPD diagnosis, management, and prevention .
    1. R Foundation for Statistical Computing. Vienna, Austria: R: A language and environment for statistical computing
    1. Stanford Medicine 25. Pulmonary exam: percussion and inspection .
    1. Stanford Medicine 25. Cardiac second sounds .
    1. Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CPM, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948–968. doi: 10.1183/09031936.05.00035205.
    1. Fedorov A, Beichel R, Kalpathy-Cramer J, Finet J, Fillion-Robin J, Pujol S, Bauer C, Jennings D, Fennessy F, Sonka M, Buatti J, Aylward S, Miller JV, Pieper S, Kikinis R. 3D Slicer as an image computing platform for the Quantitative Imaging Network. Magn Reson Imaging. 2012 Nov;30(9):1323–1341. doi: 10.1016/j.mri.2012.05.001.
    1. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 01;166(1):111–117. doi: 10.1164/ajrccm.166.1.at1102.
    1. Bowler RP, Bahr TM, Hughes G, Lutz S, Kim Y, Coldren CD, Reisdorph N, Kechris KJ. Integrative omics approach identifies interleukin-16 as a biomarker of emphysema. OMICS. 2013 Dec;17(12):619–626. doi: 10.1089/omi.2013.0038.
    1. Cohen J. Statistical Power Analysis for the Behavioral Sciences. London, UK: Taylor & Francis, Inc; 1988.
    1. Mamdani M, Sykora K, Li P, Normand S-LT, Streiner DL, Austin PC, Rochon PA, Anderson GM. Reader's guide to critical appraisal of cohort studies: 2. Assessing potential for confounding. BMJ. 2005 Apr 23;330(7497):960–962. doi: 10.1136/bmj.330.7497.960.
    1. Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399–424. doi: 10.1080/00273171.2011.568786.
    1. Rubin D. Multiple Imputation for Nonresponse in Surveys. NY, New York: Wiley, John & Sons, Incorporated; 2004.

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