NCT00285012已完成3 期
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial With 40-Week Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate For Smoking Cessation In Patients With Mild-To-Moderate Chronic Obstructive Pulmonary Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 504
- 试验地点
- 1
- 主要终点
- Number of Subjects With Four Week Continuous Quit Rate (CQR)
研究概览
简要总结
This study is to be conducted in subjects with mild-to-moderate COPD who are cigarette smokers with the intent of demonstrating differences in smoking cessation between varenicline and placebo.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be current cigarette smokers who have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit.
- •mild to moderate COPD confirmed by spirometry
- •Subjects must have a clinical diagnosis of COPD.
排除标准
- •Subjects who have made a serious attempt to quit smoking in the past 3 months.
- •Subjects who have been previously randomized in a study that has included varenicline.
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: placebo (Drug)
varenicline
Experimental
干预措施: Varenicline Tartarate (Drug)
结局指标
主要结局
Number of Subjects With Four Week Continuous Quit Rate (CQR)
时间窗: Week 9 through Week 12
Number of subjects who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory \[NUI\]) and with end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm) for weeks 9 through 12 (inclusive).
次要结局
- Number of Subjects With Continuous Abstinence (CA)(Week 9 through Week 24 and Week 52)
- Number of Subjects With Long Term Quit Rate (LTQR)(Week 24, Week 52)
- Number of Subjects With 7-Day Point Prevalence of Abstinence(Week 12, Week 24, Week 52)
- Number of Subjects With 4-Week Point Prevalence of Abstinence(Week 52)
- Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in First Second (FEV1)(Baseline, Week 12, Week 52)
- Change From Baseline in Clinical COPD Questionnaire (CCQ)(Baseline, Week, 12, Week 24, Week 52)
- Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period(Day 1 through Day 21)
- Change From Baseline in Inflammatory Biomarkers: C-Reactive Protein (CRP) and Fibrinogen Antigen(Baseline, Week 12, Week 52)
- Change From Baseline in Body Weight(Baseline, Week 52)
研究者
研究点 (1)
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