Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD).

Pfizer

Status and phase: Completed; Phase 3

Conditions: Smoking Cessation

Treatments: Drug: Varenicline Tartarate; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00285012

A3051054

Details and patient eligibility

About

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.

Enrollment: 504 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

504 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Treatment:

Drug: placebo

varenicline

Experimental group

Treatment:

Drug: Varenicline Tartarate