Clinical trial NCT00285012: Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD).
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Keywords: smoking cessation
smoking cessation in COPD
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-02-01
Enrollment: 504
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Subjects With Four Week Continuous Quit Rate (CQR)
timeFrame: Week 9 through Week 12
Secondary outcomes:
measure: Number of Subjects With Continuous Abstinence (CA)
timeFrame: Week 9 through Week 24 and Week 52
measure: Number of Subjects With Long Term Quit Rate (LTQR)
timeFrame: Week 24, Week 52
measure: Number of Subjects With 7-Day Point Prevalence of Abstinence
timeFrame: Week 12, Week 24, Week 52
measure: Number of Subjects With 4-Week Point Prevalence of Abstinence
timeFrame: Week 52
measure: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in First Second (FEV1)
timeFrame: Baseline, Week 12, Week 52
measure: Change From Baseline in Clinical COPD Questionnaire (CCQ)
timeFrame: Baseline, Week, 12, Week 24, Week 52
measure: Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
timeFrame: Day 1 through Day 21
measure: Change From Baseline in Inflammatory Biomarkers: C-Reactive Protein (CRP) and Fibrinogen Antigen
timeFrame: Baseline, Week 12, Week 52
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Farmington
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Farmington
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Maine
city: North Dartmouth
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Chapel Hill
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Brest
country: France
facility: Pfizer Investigational Site
city: Montpellier Cedex 5
country: France
facility: Pfizer Investigational Site
city: Nice
country: France
facility: Pfizer Investigational Site
city: Paris cedex 14
country: France
facility: Pfizer Investigational Site
city: Modena
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Vittorio Veneto, TV
country: Italy
facility: Pfizer Investigational Site
city: L'hospitalet Del Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Caceres
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.