Substudy of Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation (ESTxENDS Trial)- the Respiratory Symptoms Substudy of ESTxENDS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,246
- 试验地点
- 8
- 主要终点
- Assessment of respiratory symptoms (Asthma)_2
研究概览
简要总结
--> This is a substudy of the main ESTxENDS trial (NCT03589989). Respiratory symptoms outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989.
Cigarette smoking is the leading cause of preventable death in Switzerland. Cigarette smoking eventually kills one in two smokers, mostly through cancer, heart disease and respiratory failure. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer or electronic cigarette) have become popular with smokers who want to stop smoking or reduce their exposure to inhaled chemicals since ENDS use appears to be safer than tobacco smoking.
Studies suggest that ENDS use improves health outcomes, such as reducing respiratory symptoms, and presents only minimal respiratory risks, such as mild throat irritation and dry cough.
In a prospective 6-month randomized, controlled trial evaluating smoking reduction/abstinence in 300 smokers not intending to quit experimenting two different nicotine strengths of a e-cigarette model compared to its non-nicotine choice, respiratory symptoms similarly improved in all three study groups. One study compared the short-term effects of cigarette smoking to ENDS use and found that cigarette smoking led to an acute reduction in lung function, which was not observed with ENDS. Findings on short-term airway resistance is conflicting. Short term increase in resistance in ENDS users might be caused by aerosolizing the liquid, and not by the same substances that harm lung function in cigarette smokers. Smokers who shifted from tobacco cigarettes to ENDS have offered anecdotes of dramatically improved lung function, but animal models suggest that ENDS liquids can increase markers of asthma. No large randomized trials have tested the effect of ENDS on respiratory symptoms.
For the main ESTxENDS trial (NCT03589989), cigarette smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants in the control group will receive smoking cessation counseling only. All participants will be followed over a 24-months period. Respiratory symptoms such as chronic obstructive pulmonary disease (COPD), asthma and dyspnea will be assessed by means of questionnaires at baseline and at 6-, 12- and 24-months follow up. This trial will provide useful data on changes in respiratory symptoms in a large sample of participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Statisticians and laboratory personnel will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Assessment of respiratory symptoms (Asthma)_2
时间窗: 12 months post quit date
Measured using the Asthma Control Test ACT and questions from the European community respiratory health survey ECRHS. The ACT is self-administered tool with 5-items assessing the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. The scaling of items is on a 5-point scale. The scores range from 5 to 25, with higher scores reflecting greater asthma control.
Assessment of respiratory symptoms (Asthma)_3
时间窗: 24 months post quit date
Measured using the Asthma Control Test ACT and questions from the European community respiratory health survey ECRHS. The ACT is self-administered tool with 5-items assessing the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. The scaling of items is on a 5-point scale. The scores range from 5 to 25, with higher scores reflecting greater asthma control.
Assessment of respiratory symptoms (Chronic obstructive pulmonary disease (COPD)_1
时间窗: 6 months post quit date
Measured using COPD assessment test (CAT). The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The CAT has 8 items and the scaling of each item is from 1 to 5. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Assessment of respiratory symptoms (Chronic obstructive pulmonary disease (COPD)_2
时间窗: 12 months post quit date
Measured using COPD assessment test (CAT). The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The CAT has 8 items and the scaling of each item is from 1 to 5. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Assessment of respiratory symptoms (Chronic obstructive pulmonary disease (COPD)_3
时间窗: 24 months post quit date
Measured using COPD assessment test (CAT). The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The CAT has 8 items and the scaling of each item is from 1 to 5. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Assessment of respiratory symptoms (Dyspnea)_1
时间窗: 6 months post quit date
Measured using mMRC- Dyspnea scale. The mMRC Dyspnea Scale quantifies disability attributable to breathlessness, and is useful for characterizing baseline dyspnea in patients with respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4.
Assessment of respiratory symptoms (Dyspnea)_2
时间窗: 12 months post quit date
Measured using mMRC- Dyspnea scale. The mMRC Dyspnea Scale quantifies disability attributable to breathlessness, and is useful for characterizing baseline dyspnea in patients with respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4.
Assessment of respiratory symptoms (Dyspnea)_3
时间窗: 24 months post quit date
Measured using mMRC- Dyspnea scale. The mMRC Dyspnea Scale quantifies disability attributable to breathlessness, and is useful for characterizing baseline dyspnea in patients with respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4.
Assessment of respiratory symptoms (Asthma)_1
时间窗: 6 months post quit date
Measured using the Asthma Control Test ACT and questions from the European community respiratory health survey ECRHS. The ACT is self-administered tool with 5-items assessing the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. The scaling of items is on a 5-point scale. The scores range from 5 to 25, with higher scores reflecting greater asthma control.
次要结局
- Change in respiratory symptoms (Asthma)(Change from baseline to 6,12, 24 months post quit date)
- Assessment of adverse respiratory effects due to ENDS use(6,12, 24 months post quit date)
- Assessment of adverse respiratory effects due tobacco cigarette use(Change from baseline to 6,12, 24 months post quit date)
- Change in respiratory symptoms (Chronic obstructive pulmonary disease (COPD)(Change from baseline to 6,12, 24 months post quit date)
- Change in respiratory symptoms (Dyspnea)(Change from baseline to 6,12, 24 months post quit date)