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

Smoking Cessation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00285012
• Other study ID #: A3051054
• Status: Completed
• Phase: Phase 3
• First received: January 30, 2006
• Last updated: April 15, 2010
• Start date: May 2006
• Est. completion date: April 2009

Study information

• Verified date: April 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 504
• Est. completion date: April 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Smoking Cessation

Intervention

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 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)

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Brest
France	Pfizer Investigational Site	Montpellier Cedex 5
France	Pfizer Investigational Site	Nice
France	Pfizer Investigational Site	Paris cedex 14
Italy	Pfizer Investigational Site	Modena
Italy	Pfizer Investigational Site	Pisa
Italy	Pfizer Investigational Site	Vittorio Veneto, TV
Spain	Pfizer Investigational Site	Caceres
Spain	Pfizer Investigational Site	L'hospitalet Del Llobregat	Barcelona
Spain	Pfizer Investigational Site	Madrid
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Chapel Hill	North Carolina
United States	Pfizer Investigational Site	Chapel Hill	North Carolina
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	Houston	Texas
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	North Dartmouth	Massachusetts
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Portland	Maine
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Rochester	Minnesota
United States	Pfizer Investigational Site	Winston-Salem	North Carolina
United States	Pfizer Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  France,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Subjects With Continuous Abstinence (CA)	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.	Week 9 through Week 24 and Week 52	No
Secondary	Number of Subjects With Long Term Quit Rate (LTQR)	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.	Week 24, Week 52	No
Secondary	Number of Subjects With 7-Day Point Prevalence of Abstinence	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.	Week 12, Week 24, Week 52	No
Secondary	Number of Subjects With 4-Week Point Prevalence of Abstinence	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.	Week 52	No
Secondary	Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in First Second (FEV1)	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.	Baseline, Week 12, Week 52	No
Secondary	Change From Baseline in Clinical COPD Questionnaire (CCQ)	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.	Baseline, Week, 12, Week 24, Week 52	No
Secondary	Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period	Number of cigarettes smoked daily collected during the first 3 weeks of study after randomization using patient smoking diaries.	Day 1 through Day 21	No
Secondary	Change From Baseline in Inflammatory Biomarkers: C-Reactive Protein (CRP) and Fibrinogen Antigen	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).	Baseline, Week 12, Week 52	No
Secondary	Change From Baseline in Body Weight	Change from baseline calculated as mean at observation minus baseline value; body weight measured in kilograms (kg).	Baseline, Week 52	No

External Links

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