ASIA CHOICES CHampix (Varenicline) Observational Investigation in the CEssation of Smoking

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: varenicline

• Registration Number: NCT00808015
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study First Submitted: 2008-12-12
• Study First Submitted QC: 2008-12-12
• Study First Posted: 2008-12-15
• Study Start: 2009-02
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-06-30
• Results First Submitted QC: 2011-06-30
• Results First Posted: 2011-07-28
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1373

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients in routine practice	varenicline	Patients prescribed Champix by treating physician and then entered into trial

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Smoking Abstinence at Week 12	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 Outcome Measures

Name	Time	Method
CO Level at Last Observed Study Visit	Last observed study visit (Week 12 or ET)	The CO level was measured from exhaled air of the participant using CO analyzer at the last observed study visit which was the last available CO level recorded after baseline. The CO level was only measured if it was a part of the usual practice at the site.
Average Weekly Number of Cigarettes Smoked at Last Observed Study Visit	Last observed study visit (Week 12 or ET)	The average number of cigarettes smoked per day over the last 7 days was collected as a part of nicotine use inventory assessment through consent record form module which included a questionnaire: Did the participant smoke any cigarettes (even a puff) in last 7 days (Yes/No) and Did the participant use any other tobacco products (example- pipe, cigars, chew, snuff) in last 7 days (Yes/No).
Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11	Week 3 through Week 11	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.
Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit	Last observed study visit (Week 12 or early termination [ET])	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇵🇭 Quezon City, Philippines