Sharman Almaz, Zhussupov Baurzhan, Sharman Dana, Kim Irina, Yerenchina Elmira
Academy of Preventive Medicine of Kazakhstan, Clinical Research Unit, Almaty, Kazakhstan.
Synergy Research Group Kazakhstan, Almaty, Kazakhstan.
JMIR Res Protoc. 2018 Nov 5;7(11):e10006. doi: 10.2196/10006.
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.
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.
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.
Participant recruitment began December 2017, and enrollment is expected to last until late summer 2018.
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.
ClinicalTrials.gov NCT03383601; https://clinicaltrials.gov/ct2/show/NCT03383601 (Archived by WebCite at http://www.webcitation.org/72BYoAKxa).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/10006.
慢性阻塞性肺疾病（COPD）是一个全球性的公共卫生问题。它是全球第三大死因，在哈萨克斯坦是第四大死因，且与吸烟密切相关。戒烟可减轻呼吸道症状的严重程度以及慢性阻塞性肺疾病的急性加重。加热烟草制品，如由iQOS装置加热的HeatSticks，一种无烟电子装置，可能是传统可燃香烟风险较低的替代品。
本研究的目的是评估哈萨克斯坦阿拉木图40 - 59岁使用iQOS搭配HeatSticks的男性和女性与传统香烟吸烟者相比，急性加重的频率、呼吸道症状、运动不耐受情况、肺功能异常，以及其他参数和合并症。
这是一项为期5年的单中心队列观察性研究。它包括两组参与者，由居住在哈萨克斯坦阿拉木图市40 - 59岁的男性和女性组成：（1）可燃香烟吸烟者（对照组）和（2）使用iQOS搭配HeatSticks的用户（暴露组）。该研究进行了基线和定期（即每年一次）的全面临床评估，以及在5年观察期内持续的慢性阻塞性肺疾病病例发现活动和急性呼吸道加重的登记。研究措施包括肺活量测定、胸部计算机断层扫描、心电图、体格检查、血清炎症和代谢综合征生物标志物的实验室检测、人体测量学和6分钟步行试验。将使用慢性阻塞性肺疾病评估测试收集有关慢性阻塞性肺疾病症状的信息。
参与者招募于2017年12月开始，预计入组将持续到2018年夏末。
这是哈萨克斯坦第一项评估加热烟草制品iQOS搭配HeatSticks的使用者与传统可燃香烟吸烟者之间肺功能差异的队列观察性研究。研究结果将增加关于从可燃香烟转向使用iQOS搭配HeatSticks是否会影响呼吸道症状和疾病，包括慢性阻塞性肺疾病的发生和发展的知识。
ClinicalTrials.gov NCT03383601；https://clinicaltrials.gov/ct2/show/NCT03383601（由WebCite存档于http://www.webcitation.org/72BYoAKxa）。
国际注册报告识别码（IRRID）：PRR1 - 10.2196/10006。
