publication-champix pulmonologist da@fa_hr
DESCRIPTION
Arms Active: varenicline 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) 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) Control: placebo CHAMPIX ™ Placebo Adverse EventsTRANSCRIPT
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Arms Assigned Interventions Criteria
Control: placebo
Drug: placebo1mg (placebo) by mouth twice daily for 12 weeks (fi rst week up titration schedule–0.5mg once daily for 3 days, 0.5mg twice daily for 4 days)
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 confi rmed 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
Active: varenicline
Drug: Varenicline Tartrate1 mg by mouth twice daily for 12 weeks (fi rst week up titration schedule –0.5mg once daily for 3 days, 0.5mg twice daily for 4 days)
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Adverse Events 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%
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