Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD).
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
1 other identifier
interventional
504
4 countries
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2006
Typical duration for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2006
CompletedFirst Posted
Study publicly available on registry
February 1, 2006
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
December 3, 2009
CompletedApril 20, 2010
April 1, 2010
2.2 years
January 30, 2006
October 30, 2009
April 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Four Week Continuous Quit Rate (CQR)
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).
Week 9 through Week 12
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (2)
placebo
PLACEBO COMPARATORvarenicline
EXPERIMENTALInterventions
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)
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (32)
Pfizer Investigational Site
Birmingham, Alabama, 35249-2181, United States
Pfizer Investigational Site
Los Angeles, California, 90095-1690, United States
Pfizer Investigational Site
Los Angeles, California, 90095-6984, United States
Pfizer Investigational Site
Denver, Colorado, 80206, United States
Pfizer Investigational Site
Farmington, Connecticut, 06030-2810, United States
Pfizer Investigational Site
Farmington, Connecticut, 06030, United States
Pfizer Investigational Site
Miami, Florida, 33143, United States
Pfizer Investigational Site
Lexington, Kentucky, 40509, United States
Pfizer Investigational Site
Portland, Maine, 04102, United States
Pfizer Investigational Site
North Dartmouth, Massachusetts, 02747, United States
Pfizer Investigational Site
Rochester, Minnesota, 55905, United States
Pfizer Investigational Site
Omaha, Nebraska, 68198-5885, United States
Pfizer Investigational Site
Rochester, New York, 14609, United States
Pfizer Investigational Site
Chapel Hill, North Carolina, 27517, United States
Pfizer Investigational Site
Chapel Hill, North Carolina, 27599-7020, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27607, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, 27157, United States
Pfizer Investigational Site
Portland, Oregon, 97239-3098, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107, United States
Pfizer Investigational Site
Nashville, Tennessee, 37203, United States
Pfizer Investigational Site
Houston, Texas, 77030-1608, United States
Pfizer Investigational Site
Brest, 29609, France
Pfizer Investigational Site
Montpellier, 34295, France
Pfizer Investigational Site
Nice, 06000, France
Pfizer Investigational Site
Paris, 75679, France
Pfizer Investigational Site
Modena, 41100, Italy
Pfizer Investigational Site
Pisa, 56124, Italy
Pfizer Investigational Site
Vittorio Veneto, TV, 31029, Italy
Pfizer Investigational Site
L'hospitalet Del Llobregat, Barcelona, 08907, Spain
Pfizer Investigational Site
Cáceres, Caceres, 10003, Spain
Pfizer Investigational Site
Madrid, Madrid, 28015, Spain
Related Publications (4)
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PMID: 37142273DERIVEDTashkin DP, Rennard S, Taylor Hays J, Lawrence D, Marton JP, Lee TC. Lung function and respiratory symptoms in a 1-year randomized smoking cessation trial of varenicline in COPD patients. Respir Med. 2011 Nov;105(11):1682-90. doi: 10.1016/j.rmed.2011.04.016. Epub 2011 May 31.
PMID: 21621992DERIVEDTashkin DP, Rennard S, Hays JT, Ma W, Lawrence D, Lee TC. Effects of varenicline on smoking cessation in patients with mild to moderate COPD: a randomized controlled trial. Chest. 2011 Mar;139(3):591-599. doi: 10.1378/chest.10-0865. Epub 2010 Sep 23.
PMID: 20864613DERIVEDRyerson CJ, Berkeley J, Carrieri-Kohlman VL, Pantilat SZ, Landefeld CS, Collard HR. Depression and functional status are strongly associated with dyspnea in interstitial lung disease. Chest. 2011 Mar;139(3):609-616. doi: 10.1378/chest.10-0608. Epub 2010 Aug 5.
PMID: 20688924DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 30, 2006
First Posted
February 1, 2006
Study Start
May 1, 2006
Primary Completion
July 1, 2008
Study Completion
April 1, 2009
Last Updated
April 20, 2010
Results First Posted
December 3, 2009
Record last verified: 2010-04