ASIA CHOICES CHampix Observational Investigation in the CEssation of Smoking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,373
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Smoking Abstinence at Week 12
研究概览
简要总结
The purpose of this study is to describe the characteristics of the smoker who wants to quit and his/her treating physician, in addition to determine the safety and effectiveness of Champix in the real-world setting of smokers in routine clinical practice.
详细描述
Sampling Method Description: Patients enrolled after being prescribed Champix for smoking cessation at the sole discretion of treating physician and patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients enrolled should meet the usual prescribing criteria for Champix® as per the local product information and should be entered into the trial at the investigator's discretion
排除标准
- •All patients enrolled should meet the usual prescribing criteria for Champix® as per the local product information and should be entered into the trial at the investigator's discretion
研究组 & 干预措施
Patients in routine practice
Patients prescribed Champix by treating physician and then entered into trial
干预措施: varenicline (Drug)
结局指标
主要结局
Percentage of Participants With Smoking Abstinence at Week 12
时间窗: Week 12
Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.
次要结局
- CO Level at Last Observed Study Visit(Last observed study visit (Week 12 or ET))
- Average Weekly Number of Cigarettes Smoked at Last Observed Study Visit(Last observed study visit (Week 12 or ET))
- Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11(Week 3 through Week 11)
- Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit(Last observed study visit (Week 12 or early termination [ET]))