Department of Internal Medicine C, Section of Respiratory Medicine, Herlev and Gentofte University Hospital, Hellerup, Denmark.
Department of Internal Medicine, Zealand University Hospital, Roskilde, Denmark.
Trials. 2020 Aug 21;21(1):730. doi: 10.1186/s13063-020-04653-z.
Cigarette smoking is the leading cause of chronic obstructive pulmonary disease (COPD), and it contributes to the development of many other serious diseases. Smoking cessation in COPD patients is known to improve survival and reduce the number of hospitalization-requiring acute exacerbations of COPD. However, smoking cessation interventions in these patients have only been successful for approximately 15-20% for consistent smoking abstinence in 12 months. Thus, more effective interventions are needed for this patient group. The aim of this study is to determine whether a high-intensity intervention compared to a low-intensity intervention can increase the proportion of persistent (> 12 months) anamnestic and biochemical smoking cessation in active smokers with COPD.
This study is a randomized controlled trial. A total of 600 active smokers with COPD will be randomly assigned 1:1 to either a standard treatment (guideline-based municipal smoking cessation program, "low intensity" group) or an intervention ("high-intensity" group) group, which consists of group sessions, telephone consultations, behavior design, hotline, and "buddy-matching" (smoker matched with COPD patient who has ceased smoking). Both groups will receive pharmacological smoking cessation. The primary endpoint is anamnestic and biochemical (cotinine analysis in urine) validated smoking cessation after 12 months.
The potential benefit of this project is to improve smoking cessation rates and thereby reduce smoking-related exacerbations of COPD. In addition, the project can potentially benefit from increasing the quality of life and longevity of COPD patients and reducing the risk of other smoking-related diseases.
ClinicalTrials.gov NCT04088942 . Registered on 13 September 2019.
吸烟是慢性阻塞性肺疾病（COPD）的主要原因，它还会导致许多其他严重疾病的发生。COPD 患者戒烟已知可提高生存率并减少 COPD 急性加重需要住院治疗的次数。然而，这些患者的戒烟干预措施仅在大约 15-20%的患者中成功实现了 12 个月的持续戒烟。因此，需要为这一患者群体提供更有效的干预措施。本研究旨在确定与低强度干预相比，高强度干预是否可以增加 COPD 活跃吸烟者持续（>12 个月）记忆和生化戒烟的比例。
这是一项随机对照试验。共有 600 名 COPD 活跃吸烟者将被随机分配 1:1 接受标准治疗（基于指南的市政戒烟计划，“低强度”组）或干预（“高强度”组），干预措施包括小组会议、电话咨询、行为设计、热线和“伙伴匹配”（将吸烟者与已戒烟的 COPD 患者匹配）。两组都将接受药物戒烟。主要终点是 12 个月后记忆和生化（尿液中可替宁分析）验证的戒烟。
该项目的潜在好处是提高戒烟率，从而减少与吸烟有关的 COPD 加重。此外，该项目还有可能通过提高 COPD 患者的生活质量和延长寿命以及降低其他与吸烟有关的疾病的风险而受益。
ClinicalTrials.gov NCT04088942。于 2019 年 9 月 13 日注册。
