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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00285012

Purpose

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.

Condition	Intervention	Phase
Smoking	Drug: placebo Drug: Varenicline Tartarate	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Quitting Smoking Smoking

Drug Information available for: Varenicline

U.S. FDA Resources

Further study details as provided by Pfizer:

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 ]

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 ]

Enrollment:	504
Study Start Date:	May 2006
Study Completion Date:	April 2009
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
placebo: Placebo Comparator	Drug: placebo 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: Experimental	Drug: Varenicline Tartarate 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)

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285012

Show 33 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3051054
Study First Received:	January 30, 2006
Last Updated:	July 6, 2009
ClinicalTrials.gov Identifier:	NCT00285012 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

smoking cessation smoking cessation in COPD

Study placed in the following topic categories:

Smoking
Lung Diseases, Obstructive
Respiratory Tract Diseases

Lung Diseases
Varenicline
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Habits
Smoking
Lung Diseases, Obstructive

Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on August 30, 2009