Smoking Cessation
Conditions
Keywords
Smoking; smoking cessation; Philippines; Varenicline
Brief summary
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
The study will enroll smoking patients.
Interventions
DRUGVarenicline
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.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4 | 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. |
| Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 8 | 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. |
| Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 12 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varenicline Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks). | 330 |
| Total | 330 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 10 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Lost to Follow-up | 38 |
| Overall Study | Other | 17 |
| Overall Study | Poor Compliance | 11 |
Baseline characteristics
| Characteristic | Varenicline |
|---|---|
| Age, Customized 18 to 44 years | 137 participants |
| Age, Customized 45 to 64 years | 137 participants |
| Age, Customized 65 years and older | 22 participants |
| Age, Customized Less than 18 years | 2 participants |
| Age, Customized Unspecified | 32 participants |
| Fagerstrom Test for Nicotine Dependence: Ability to refrain from smoking where it is forbidden No | 50.9 percentage of participants |
| Fagerstrom Test for Nicotine Dependence: Ability to refrain from smoking where it is forbidden Yes | 49.1 percentage of participants |
| Fagerstrom Test for Nicotine Dependence: Cigarettes a day 10 cigarettes or less | 21.2 percentage of participants |
| Fagerstrom Test for Nicotine Dependence: Cigarettes a day 11 to 20 cigarettes | 49.4 percentage of participants |
| Fagerstrom Test for Nicotine Dependence: Cigarettes a day 21 to 30 cigarettes | 20.3 percentage of participants |
| Fagerstrom Test for Nicotine Dependence: Cigarettes a day 31 or more cigarettes | 7.9 percentage of participants |
| Fagerstrom Test for Nicotine Dependence: Cigarettes a day No information | 1.2 percentage of participants |
| Fagerstrom Test for Nicotine Dependence: Frequency of smoking during first hours after waking No | 52.1 percentage of participants |
| Fagerstrom Test for Nicotine Dependence: Frequency of smoking during first hours after waking No information | 0.6 percentage of participants |
| Fagerstrom Test for Nicotine Dependence: Frequency of smoking during first hours after waking Yes | 47.3 percentage of participants |
| Fagerstrom Test for Nicotine Dependence (FTND): Time to first cigarette after waking 31 to 60 minutes after waking | 18.2 percentage of participants |
| Fagerstrom Test for Nicotine Dependence (FTND): Time to first cigarette after waking 6 to 30 minutes after waking | 35.2 percentage of participants |
| Fagerstrom Test for Nicotine Dependence (FTND): Time to first cigarette after waking More than 60 minutes after waking | 25.5 percentage of participants |
| Fagerstrom Test for Nicotine Dependence (FTND): Time to first cigarette after waking Within 5 minutes after waking | 21.2 percentage of participants |
| Fagerstrom Test for Nicotine Dependence: Most difficult cigarette to give up Any other cigarette | 58.8 percentage of participants |
| Fagerstrom Test for Nicotine Dependence: Most difficult cigarette to give up No information | 3.0 percentage of participants |
| Fagerstrom Test for Nicotine Dependence: Most difficult cigarette to give up The first cigarette in the morning | 38.2 percentage of participants |
| Fagerstrom Test for Nicotine Dependence: Smoking when ill No | 72.7 percentage of participants |
| Fagerstrom Test for Nicotine Dependence: Smoking when ill No information | 0.9 percentage of participants |
| Fagerstrom Test for Nicotine Dependence: Smoking when ill Yes | 26.4 percentage of participants |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 275 Participants |
| Total score on the Fagerstrom Test for Nicotine Dependence | 4.2 scores on a scale STANDARD_DEVIATION 2.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 44 / 330 |
| serious Total, serious adverse events | 0 / 330 |
Outcome results
Primary
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.
Time frame: Week 12
Population: Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 12 | 57.58 percentage of participants |
Primary
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.
Time frame: Week 4
Population: Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4 | 58.79 percentage of participants |
Primary
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.
Time frame: Week 8
Population: Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 8 | 61.52 percentage of participants |