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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 30, 2006

Last Updated Date

April 14, 2009

Start Date ^†

May 2006

Current Primary Outcome Measures ^†

4-wk continuous quit rate (CQR) for Wks 9-12, exhaled CO measurements less than or equal to 10 ppm, for the planned last 4 wks of treatment. [ Time Frame: wk 9-12 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

The 4-week continuous quit rate for Weeks 9-12 with end-expiratory exhaled CO measurements â‰¤10ppm, for the planned last 4 weeks of treatment.

Change History

Complete list of historical versions of study NCT00285012 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Proportion of subjects who have successfully quit during the treatment phase of the study based on the 4-wk CQR from Wk 9 through Wk 12 and who have had no more than 6 days of smoking during the non-treatment phase of the study. [ Time Frame: wk 9-52 ] [ Designated as safety issue: No ]
7 day point prevalence of smoking cessation at weeks 12, 24, and 52 [ Time Frame: wks 12, 24, 52 ] [ Designated as safety issue: No ]
change from baseline in pre and post bronchodilator FEV1 (lung function test) at weeks 12 and 52 [ Time Frame: wks 12,52 ] [ Designated as safety issue: No ]
change from baseline in clinical COPD questionnaire [ Time Frame: wk 52 ] [ Designated as safety issue: No ]
4 wk point prevalence of smoking [ Time Frame: wk 52 ] [ Designated as safety issue: No ]
blood markers of inflammation [ Time Frame: wk 12,52 ] [ Designated as safety issue: No ]
daily cigarette consumption [ Time Frame: wk 1-3 ] [ Designated as safety issue: No ]
Continuous abstinence (CA) from Wk 9 through Wk 52 [ Time Frame: wk 9-52 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Continuous abstinence from Week 9 through Week 52 and long-term quit rate through Week 52.

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^†

Smoking

Intervention ^†

Drug: placebo
Drug: Varenicline Tartarate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

500

Estimated Completion Date

April 2009

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

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.

Gender

Both

Ages

35 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, France, Italy, Spain

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00285012

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.