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

• ClinicalTrials.gov Identifier: NCT00285012
• Recruitment Status: Completed
• First Posted: February 1, 2006
• Results First Posted: December 3, 2009
• Last Update Posted: April 20, 2010
• Sponsor: Pfizer
• Information provided by: Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	Drug: placebo; Drug: Varenicline Tartarate	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 504 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: May 2006
• Actual Primary Completion Date: July 2008
• Actual Study Completion Date: April 2009

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: placebo	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)
Experimental: varenicline	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); Other Name: Chantix, Champix

Outcome Measures

Primary Outcome Measures :

1. Number of Subjects With Four Week Continuous Quit Rate (CQR) [ Time Frame: Week 9 through Week 12 ]
   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).

Secondary Outcome Measures :

1. Number of Subjects With Continuous Abstinence (CA) [ Time Frame: Week 9 through Week 24 and Week 52 ]
   Number of subjects who reported no smoking and no use of other nicotine-containing products (treatment phase = through week 12) or tobacco products (non-treatment phase = after treatment phase; follow up through week 52) at each contact (on the NUI) and with end-expiratory exhaled CO measurement less than or equal to 10 ppm from week 9 through week 24 and week 52. CO confirmed in-clinic visit.
2. Number of Subjects With Long Term Quit Rate (LTQR) [ Time Frame: Week 24, Week 52 ]

   Number of subjects who were responders for the primary endpoint (4-week CQR for Weeks 9 through 12) and who had no more than 6 cumulative days of smoking from Week 12 through the given visit (Week 24 and Week 52).

   CO confirmed in-clinic visit.

3. Number of Subjects With 7-Day Point Prevalence of Abstinence [ Time Frame: Week 12, Week 24, Week 52 ]
   Number of subjects at given visit (Week 12, Week 24, Week 52) or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and with end-expiratory exhaled CO measurement less than or equal to 10 ppm. CO confirmed in-clinic visit.
4. Number of Subjects With 4-Week Point Prevalence of Abstinence [ Time Frame: Week 52 ]
   Number of subjects at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks and with end-expiratory exhaled CO measurement less than or equal to 10 ppm.
5. Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in First Second (FEV1) [ Time Frame: Baseline, Week 12, Week 52 ]
   Change from baseline in mean FEV1 (forced expiratory volume in the first second of forced exhalation) measured in millimeters (ml) as mean at observation minus baseline value. Directly after pre-bronchodilator measurement, subject inhaled albuterol or salbutamol delivered by metered-dose inhaler (MDI); post-bronchodilator lung function repeated 30 to 45 minutes following administration of albuterol or salbutamol.
6. Change From Baseline in Clinical COPD Questionnaire (CCQ) [ Time Frame: Baseline, Week, 12, Week 24, Week 52 ]
   Change from baseline: mean at observation minus baseline value. Subject-administered 10-item instrument to systematically assess COPD symptoms (items 1, 2, 5, and 6), functional states (items 7, 8, 9, and 10) and mental states (items 3 and 4); For each domain score = sum of items divided by the number of items; total score = sum of scores divided by 10; range from 0 (very good health) to 6 (extremely poor health). Assessed at each visit based on subject's experience during the week prior to visit.
7. Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period [ Time Frame: Day 1 through Day 21 ]
   Number of cigarettes smoked daily collected during the first 3 weeks of study after randomization using patient smoking diaries.
8. Change From Baseline in Inflammatory Biomarkers: C-Reactive Protein (CRP) and Fibrinogen Antigen [ Time Frame: Baseline, Week 12, Week 52 ]
   Change from baseline in CRP and Fibrinogen antigen (blood markers of inflammation) calculated as mean at observation minus baseline value; measured as milligrams per deciliter (mg/dl).
9. Change From Baseline in Body Weight [ Time Frame: Baseline, Week 52 ]
   Change from baseline calculated as mean at observation minus baseline value; body weight measured in kilograms (kg).

Eligibility Criteria

• Ages Eligible for Study: 35 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Alabama

Pfizer Investigational Site

Birmingham, Alabama, United States, 35249-2181

United States, California

Pfizer Investigational Site

Los Angeles, California, United States, 90095-1690

Pfizer Investigational Site

Los Angeles, California, United States, 90095-6984

United States, Colorado

Pfizer Investigational Site

Denver, Colorado, United States, 80206

United States, Connecticut

Pfizer Investigational Site

Farmington, Connecticut, United States, 06030-2810

Pfizer Investigational Site

Farmington, Connecticut, United States, 06030

United States, Florida

Pfizer Investigational Site

Miami, Florida, United States, 33143

United States, Kentucky

Pfizer Investigational Site

Lexington, Kentucky, United States, 40509

United States, Maine

Pfizer Investigational Site

Portland, Maine, United States, 04102

United States, Massachusetts

Pfizer Investigational Site

North Dartmouth, Massachusetts, United States, 02747

United States, Minnesota

Pfizer Investigational Site

Rochester, Minnesota, United States, 55905

United States, Nebraska

Pfizer Investigational Site

Omaha, Nebraska, United States, 68198-5885

United States, New York

Pfizer Investigational Site

Rochester, New York, United States, 14609

United States, North Carolina

Pfizer Investigational Site

Chapel Hill, North Carolina, United States, 27517

Pfizer Investigational Site

Chapel Hill, North Carolina, United States, 27599-7020

Pfizer Investigational Site

Raleigh, North Carolina, United States, 27607

Pfizer Investigational Site

Winston-Salem, North Carolina, United States, 27103

Pfizer Investigational Site

Winston-Salem, North Carolina, United States, 27157

United States, Oregon

Pfizer Investigational Site

Portland, Oregon, United States, 97239-3098

United States, Pennsylvania

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States, 19107

United States, Tennessee

Pfizer Investigational Site

Nashville, Tennessee, United States, 37203

United States, Texas

Pfizer Investigational Site

Houston, Texas, United States, 77030-1608

France

Pfizer Investigational Site

Brest, France, 29609

Pfizer Investigational Site

Montpellier Cedex 5, France, 34295

Pfizer Investigational Site

Nice, France, 06000

Pfizer Investigational Site

Paris cedex 14, France, 75679

Italy

Pfizer Investigational Site

Modena, Italy, 41100

Pfizer Investigational Site

Pisa, Italy, 56124

Pfizer Investigational Site

Vittorio Veneto, TV, Italy, 31029

Spain

Pfizer Investigational Site

L'hospitalet Del Llobregat, Barcelona, Spain, 08907

Pfizer Investigational Site

Caceres, Spain, 10003

Pfizer Investigational Site

Madrid, Spain, 28015

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. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
• ClinicalTrials.gov Identifier: NCT00285012
• Other Study ID Numbers: A3051054
• First Posted: February 1, 2006
• Results First Posted: December 3, 2009
• Last Update Posted: April 20, 2010
• Last Verified: April 2010

Keywords provided by Pfizer:

smoking cessation; smoking cessation in COPD

Additional relevant MeSH terms:

Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Tract Diseases; Varenicline; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs