Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients

Study Overview
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Brief Summary
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The primary objective of this Post-Marketing Study is to monitor the safety of a novel smoking cessation drug Varenicline (Champix™) 0.5 mg and 1 mg tablets as used in clinical practice for 12 weeks among Filipino smokers. The secondary objective is to further evaluate the effectiveness of Varenicline (Champix™) as an aid in smoking cessation based on the 7-day point prevalence of smoking cessation

Detailed Description
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The study will enroll smoking patients.

Official Title
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Post-Marketing Surveillance Study To Observe The Safety And Effectiveness Of Varenicline (Champix) Tablets In Smoking Cessation Among Filipino Subjects

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Varenicline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smoking adults aged ≥ 18 years intending to quit tobacco use who are prescribed Varenicline (Champix™) by their Physicians and those who are prescribed with Varenicline (Champix™) for the first time. Exclusion Criteria: Subjects in whom varenicline (Champix™) may be taken in a manner that is not according to the approved local product document. Pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception Subjects with known hypersensitivity to varenicline.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open-label<br> | Drug: Varenicline<br>* There are two packs available for Varenicline (Champix™). The titration pack is prescribed initially to subjects with the recommended 1-week titration phase schedule as follows: Days 1-3 0.5 mg once daily Days 4-7 0.5 mg twice daily Day 8 - End of treatment 1 mg twice daily Following the titration period, Varenicline (Champix™) dosing is increased to 1mg twice daily for the remainder of the treatment period. Patient should set the target quit date to coincide with the start of 1 mg twice daily dosing. It should be taken after eating and with a full glass of water.<br>* Other names: Chantix, Champix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4 | Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study. | Week 4 | 
| Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 8 | Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study. | Week 8 | 
| Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 12 | Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study. | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking; smoking cessation; Philippines; Varenicline