ASIA CHOICES CHampix Observational Investigation in the CEssation of Smoking
Overview
- Phase
- Not Applicable
- Intervention
- varenicline
- Conditions
- Smoking Cessation
- Sponsor
- Pfizer
- Enrollment
- 1373
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Smoking Abstinence at Week 12
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
Sampling Method Description: Patients enrolled after being prescribed Champix for smoking cessation at the sole discretion of treating physician and patient.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Patients in routine practice
Patients prescribed Champix by treating physician and then entered into trial
Intervention: varenicline
Outcomes
Primary Outcomes
Percentage of Participants With Smoking Abstinence at Week 12
Time Frame: 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.
Secondary Outcomes
- 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]))