A Randomized Open-label, Superiority, Multicenter, Two-arm Intervention Study of the Effect of "High-intensity" vs. 'Low-intensity' Smoking Cessation Intervention in Active Smokers With COPD
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Anamnestic and biochemical* validated smoking cessation
研究概览
简要总结
Background:
Cigarette smoking is the leading cause of chronic obstructive pulmonary disease (COPD) and it contributes to the development of many other serious diseases. Acute exacerbations of COPD (AECOPD) often lead to hospitalization. Severe hospitalization-requiring AECOPD carries very high economic costs for the healthcare system, and personal costs for patients. Smoking cessation in COPD for the healthcare system, and personal costs for patients. Smoking cessation in COPD patients is known to improve survival and reduce the number of AECOPD. However, smoking cessation interventions in these patients have only been successful for consistent smoking abstinence in 12 months in approximately 15-20%. Thus, more effective interventions are needed for this patient group.
Aims:
The aim of this study is to determine, among people with chronic obstructive pulmonary disease (COPD), whether a "high-intensive" smoking cessation intervention in comparison to a standard intervention can lead to permanent, >12 months, smoking cessation in a higher proportion.
Methods:
This study is a randomized trial in active smokers with COPD and who have lost less than 50% lung function. A total of 600 participants will be randomly assigned 1:1 to either a standard treatment (guideline-based municipal smoking cessation programme, "low intensity" group), or an intervention group ("high-intensity" group), which consists of group sessions, telephone consultations, behavior design, hotline, "buddy-matching" (smoker matched with COPD patient who stopped). Both groups will receive pharmacological smoking cessation.
Discussion:
The potential benefit of this project is to prevent smoking-related exacerbations of COPD and thereby reduce logistics and costs of hospitalization and treatment 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 developing lung cancer and other smoking-related diseases.
详细描述
Hypothesis:
A "high-intensity" smoking cessation intervention is superior in leading to permanent (>12 months) smoking cessation in active smokers with COPD than does a standard, guideline-based municipal smoking cessation intervention.
Secondary hypothesis: The progression of COPD will be reduced in the "high intensity group", and this will result in limited loss of lung function, a reduced number of exacerbations of COPD, improved mental health and self-rated health.
Rationale:
Smoking cessation in COPD patients improves survival and reduces the number of exacerbations. Unfortunately, relatively few COPD patients are successful in permanently stopping to smoke, even with pharmacological help.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Competent and mature
- •Have diagnosed COPD [spirometry verified and evaluated by pulmonary specialist]
- •Current daily smoker [Minimum 1 cigarette daily]
- •Have smoked minimum 20 pack years (1 pack year = 20 cigarettes daily in 1 year)
- •Want to or try to stop smoking
- •Do not mind taking varenicline or NRT during the trial
- •Are willing to give blood and urine samples according to the protocol
排除标准
- •Previously included in the trial
- •Hospitalized with COPD-exacerbation within the last 24 months
- •Are associated with hospital outpatient clinic for COPD disease treatment
- •Have FEV1<50%.
- •Pregnancy/breastfeeding
- •Life expectancy less than 1 year
- •Severe linguistic problems or inability to give informed consent
- •Severe mental illness that is not controlled with medication
- •Active alcohol or substance abuse
- •Active cancer disease* *The person can participate if he or she has had a cancer disease that is now referred to as curative/radically treated. Basal cell carcinoma of the skin does not count as an exclusion criterion.
研究组 & 干预措施
High-intensity group
Will receive "high-intensity" intervention, which is a combination of pharmacological (varenicline) and behavioural support, described later.
干预措施: High-intensity smoking cessation intervention (Other)
Low-intensity group
Encouraged to quit smoking via own doctor and is prescribed varenicline.
干预措施: Low-intensity smoking cessation intervention (Drug)
结局指标
主要结局
Anamnestic and biochemical* validated smoking cessation
时间窗: 12 months after inclusion
\*Cotinine is analyzed in a urine sample, as validated point-prevalence for the last 7 days
次要结局
- Number of admissions for all causes or death(Within 12 months after inclusion)
- Number of cardiovascular events(Within 12 months after inclusion)
- Occurrence of DNA from the following: M. catarrhalis, H. influenzae and P. aeruginosa(12 months after inclusion)
- Occurrence of smoking-related cancer(Within 12 months after inclusion)
- Changes in the total lung microbiome(12 months after inclusion)
- Changes in status from MRC-dyspnea score from < 3 to 3 ≥ (Medical Research Council dyspnea scale)(12 months after inclusion)
- Number of admissions for exacerbations of COPD or death(Within 12 months after inclusion)
- Number of admissions requiring non-invasive ventilation (NIV) treatment or admissions to intensive care or death(Within 12 months after inclusion)
- Changes in CAT-score (COPD Assessment Test)(12 months after inclusion)
- Changes in FEV1 from baseline(12 months after inclusion)
- Changes in BMI(12 months after inclusion)
- Clinically relevant changes in HADS-score (Hospital Anxiety and Depression Scale)(12 months after inclusion)
研究者
Pradeesh Sivapalan
MD, PhD student
Chronic Obstructive Pulmonary Disease Trial Network, Denmark