27212-Champix Pulmonologist DA@FA_P.indd 1
3/4/10 11:32:24 AM
27212-Champix Pulmonologist DA@FA_P.indd 2-3
3/4/10 11:32:29 AM
27212-Champix Pulmonologist DA@FA_P.indd 4-5
3/4/10 11:32:30 AM
27212-Champix Pulmonologist DA@FA_P.indd 6-7
3/4/10 11:32:30 AM
Arms
Assigned Interventions
Control: placebo
Drug: placebo 1mg (placebo) by mouth twice daily for 12 weeks (first week up titration schedule – 0.5mg once daily for 3 days, 0.5mg twice daily for 4 days)
Active: varenicline
27212-Champix Pulmonologist DA@FA_P.indd 8-9
Drug: Varenicline Tartrate 1 mg by mouth twice daily for 12 weeks (first week up titration schedule – 0.5mg once daily for 3 days, 0.5mg twice daily for 4 days)
Criteria Inclusion Criteria: • Subjects will be current cigarette smokers who have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit • Mild-to-moderate COPD confirmed by spirometry • Subjects must have a clinical diagnosis of COPD Exclusion Criteria: • Subjects who have made a serious attempt to quit smoking in the past 3 months • Subjects who have been previously randomized in a study that has included varenicline
3/4/10 11:32:32 AM
27212-Champix Pulmonologist DA@FA_P.indd 10-11
3/4/10 11:32:32 AM
27212-Champix Pulmonologist DA@FA_P.indd 12-13
3/4/10 11:32:32 AM
CHAMPIX™
Placebo
Nausea
28.6%
8.8%
- mild
71.5%
84.5%
- moderate
24.7%
11.3%
- severe
3.8%
4.2%
Insomnia
13.8%
10.6%
Abnormal dreams
12.4%
4.5%
Headache
10.2%
8.7%
Constipation
5.8%
2.2%
Dry Mouth
5.6%
4.1%
Dizziness
5.2%
4.6%
Flatulence
5.1%
2.5%
Adverse Events
27212-Champix Pulmonologist DA@FA_P.indd 14-15
3/4/10 11:32:34 AM
27212-Champix Pulmonologist DA@FA_P.indd 16-17
3/4/10 11:32:34 AM
27212-Champix Pulmonologist DA@FA_P.indd 18
3/4/10 11:32:35 AM