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

April 15, 2010 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

504

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • 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
        • Pfizer Investigational Site
  • Italy
      • Modena, Italy, 41100
        • Pfizer Investigational Site
      • Pisa, Italy, 56124
        • Pfizer Investigational Site
      • Vittorio Veneto, TV, Italy, 31029
        • Pfizer Investigational Site
  • Spain
      • Caceres, Spain, 10003
        • Pfizer Investigational Site
      • Madrid, Spain, 28015
        • Pfizer Investigational Site
    • Barcelona
      • L'hospitalet Del Llobregat, Barcelona, Spain, 08907
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249-2181
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, United States, 90095-1690
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90095-6984
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80206
        • Pfizer Investigational Site
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Pfizer Investigational Site
      • Farmington, Connecticut, United States, 06030-2810
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, United States, 33143
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Pfizer Investigational Site
    • Maine
      • Portland, Maine, United States, 04102
        • Pfizer Investigational Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Pfizer Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198-5885
        • Pfizer Investigational Site
    • New York
      • Rochester, New York, United States, 14609
        • Pfizer Investigational Site
    • North Carolina
      • 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, 27157
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77030-1608
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • Chantix, Champix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Week 9 through Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 9 through Week 24 and Week 52
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.
Week 24, Week 52
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.
Week 12, Week 24, Week 52
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.
Week 52
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.
Baseline, Week 12, Week 52
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.
Baseline, Week, 12, Week 24, Week 52
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.
Day 1 through Day 21
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).
Baseline, Week 12, Week 52
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).
Baseline, Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

January 30, 2006

First Submitted That Met QC Criteria

January 30, 2006

First Posted (ESTIMATE)

February 1, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 20, 2010

Last Update Submitted That Met QC Criteria

April 15, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3051054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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