Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00285012 | Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD). | PHASE3 | COMPLETED | 504 | — | — | May 1, 2006 | Apr 1, 2009 | Apr 20, 2010 | 32 | United States, France +2 |
Number of subjects who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory \[NUI\]) and with end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm) for weeks 9 through 12 (inclusive).
| Arm | Type | Description |
|---|---|---|
| placebo | PLACEBO_COMPARATOR | - |
| varenicline | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| placebo | DRUG | 1mg (placebo) by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days) |
| Varenicline Tartarate | DRUG | 1 mg by mouth twice daily for 12 weeks (first week is 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 confirmed by spirometry * Subjects must have a clinical diagnosis of COPD. E...