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

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

MedlinePlus related topics:

COPD (Chronic Obstructive Pulmonary Disease) Smoking Smoking Cessation

ChemIDplus related topics:

Varenicline Varenicline tartrate

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	500
Study Start Date:	May 2006
Estimated Study Completion Date:	March 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

Contacts


Contact: Pfizer CT.gov Call Center	1-800-718-1021

Show 32 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Responsible Party:	Pfizer ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3051054
First Received:	January 30, 2006
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00285012
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

Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on October 03, 2008

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