NCT00808015 - ASIA CHOICES CHampix (Varenicline) Observational Investigation in the CEssation of Smoking | Crick

Overview

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.

Sampling Method Description: Patients enrolled after being prescribed Champix for smoking cessation at the sole discretion of treating physician and patient.

Study Type

OBSERVATIONAL

Enrollment

1,373

Conditions

Smoking Cessation

Interventions

vareniclineDRUG

Champix will be prescribed as per usual practice and at the sole discretion of the physician

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (97)

Outcomes

Primary Outcomes

Percentage of Participants With Smoking Abstinence at 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.

Time frame: Week 12

Secondary Outcomes

Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit

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.

Time frame: Last observed study visit (Week 12 or early termination [ET])

Percentage of Participants With Smoking Abstinence Status From Week 3 to 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.

Time frame: Week 3 through Week 11