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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Presence of respiratory symptoms defined by CAT≥10
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •Age 40-59 years inclusive
- •Smoking history ≥10 pack-years (for both cohorts)
- •Ability to follow study procedures
排除标准
- •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
结局指标
主要结局
Presence of respiratory symptoms defined by CAT≥10
时间窗: 5 years
The total COPD Assessment Test Scores 10 and more as an indicator of more symptoms
Respiratory exacerbations
时间窗: 5 years
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).
Functional exercise incapacity
时间窗: 5 years
Less than 450 meters walked during the six-minute walk test
次要结局
- Clinical findings by physical cardiac second sounds exams(5 years)
- Evidence of chronic obstructive pulmonary disease(5 years)
- ECG abnormalities(5 years)
- Clinical findings by physical pulmonary exam(5 years)
- Metabolic syndrome(5 years)
- Decreased Oxygen saturation(5 years)
- Low Dose Computerised Tomography (LDCT) of the Chest Features(5 years)