Phase 3
N=504
Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD).
Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT00285012 ↗Enrolled (actual)
504
Serious AEs
3.4%
Results posted
Dec 2009
Primary outcome: Primary: Number of Subjects With Four Week Continuous Quit Rate (CQR) — 105; 22 participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- placebo (Drug); Varenicline Tartarate (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Four Week Continuous Quit Rate (CQR) |
105; 22 | <0.0001 sig |
| SECONDARY Number of Subjects With Continuous Abstinence (CA) |
125; 28; 64; 18; 46; 14 | <0.0001 sig |
| SECONDARY Number of Subjects With Long Term Quit Rate (LTQR) |
70; 19; 53; 17 | <0.0001 sig |
| SECONDARY Number of Subjects With 7-Day Point Prevalence of Abstinence |
119; 31; 74; 34; 65; 36 | <0.0001 sig |
| SECONDARY Number of Subjects With 4-Week Point Prevalence of Abstinence |
65; 33 | 0.0002 sig |
| SECONDARY Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in First Second (FEV1) |
33.69; 1.77; 73.84; 15.61; -29.59; -37.90 | 0.140 |
| SECONDARY Change From Baseline in Clinical COPD Questionnaire (CCQ) |
-0.81; -0.64; -0.72; -0.49; -0.58; -0.46 | 0.078 |
| SECONDARY Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period |
19.9; 18.7; 18.8; 18.4; 17.7; 17.4 | — |
| SECONDARY Change From Baseline in Inflammatory Biomarkers: C-Reactive Protein (CRP) and Fibrinogen Antigen |
-0.0; -0.0; 0.0; 0.1; -25.2; -1.4 | — |
| SECONDARY Change From Baseline in Body Weight |
2.4; 1.5 | — |
Summary
This study is to be conducted in subjects with mild-to-moderate COPD who are cigarette smokers with the intent of demonstrating differences in smoking cessation between varenicline and placebo.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00285012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.