Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD).
NCT ID: NCT00285012
Last Updated: 2010-04-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
504 participants
INTERVENTIONAL
2006-05-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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placebo
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
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)
Interventions
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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 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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* mild to moderate COPD confirmed by spirometry
* Subjects must have a clinical diagnosis of COPD.
Exclusion Criteria
* Subjects who have been previously randomized in a study that has included varenicline.
35 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
Farmington, Connecticut, United States
Pfizer Investigational Site
Farmington, Connecticut, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Lexington, Kentucky, United States
Pfizer Investigational Site
Portland, Maine, United States
Pfizer Investigational Site
North Dartmouth, Massachusetts, United States
Pfizer Investigational Site
Rochester, Minnesota, United States
Pfizer Investigational Site
Omaha, Nebraska, United States
Pfizer Investigational Site
Rochester, New York, United States
Pfizer Investigational Site
Chapel Hill, North Carolina, United States
Pfizer Investigational Site
Chapel Hill, North Carolina, United States
Pfizer Investigational Site
Raleigh, North Carolina, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Nashville, Tennessee, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Brest, , France
Pfizer Investigational Site
Montpellier, , France
Pfizer Investigational Site
Nice, , France
Pfizer Investigational Site
Paris, , France
Pfizer Investigational Site
Modena, , Italy
Pfizer Investigational Site
Pisa, , Italy
Pfizer Investigational Site
Vittorio Veneto, TV, , Italy
Pfizer Investigational Site
L'hospitalet Del Llobregat, Barcelona, Spain
Pfizer Investigational Site
Cáceres, Caceres, Spain
Pfizer Investigational Site
Madrid, Madrid, Spain
Countries
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References
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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.
Tashkin 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.
Tashkin 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.
Ryerson 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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3051054
Identifier Type: -
Identifier Source: org_study_id
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