A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial With 40-Week Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate For Smoking Cessation In Patients With Mild-To-Moderate Chronic Obstructive Pulmonary Disease

Pfizer1 site in 1 country504 target enrollmentMay 2006

ConditionsSmoking Cessation

Interventionsplacebo Varenicline Tartarate

Drugsplacebo Varenicline Tartarate

Overview

Phase: Phase 3
Intervention: placebo
Conditions: Smoking Cessation
Sponsor: Pfizer
Enrollment: 504
Locations: 1
Primary Endpoint: Number of Subjects With Four Week Continuous Quit Rate (CQR)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 2006

End Date

April 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

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.

Arms & Interventions

placebo

Intervention: placebo

varenicline

Intervention: Varenicline Tartarate

Outcomes

Primary Outcomes

Number of Subjects With Four Week Continuous Quit Rate (CQR)

Time Frame: Week 9 through Week 12

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).

Secondary Outcomes

Number of Subjects With Continuous Abstinence (CA)(Week 9 through Week 24 and Week 52)
Number of Subjects With Long Term Quit Rate (LTQR)(Week 24, Week 52)
Number of Subjects With 7-Day Point Prevalence of Abstinence(Week 12, Week 24, Week 52)
Number of Subjects With 4-Week Point Prevalence of Abstinence(Week 52)
Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in First Second (FEV1)(Baseline, Week 12, Week 52)
Change From Baseline in Clinical COPD Questionnaire (CCQ)(Baseline, Week, 12, Week 24, Week 52)
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period(Day 1 through Day 21)
Change From Baseline in Inflammatory Biomarkers: C-Reactive Protein (CRP) and Fibrinogen Antigen(Baseline, Week 12, Week 52)
Change From Baseline in Body Weight(Baseline, Week 52)