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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00285012
First received: January 30, 2006
Last updated: April 15, 2010
Last verified: April 2010
  Purpose

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 Intervention Phase
Smoking Cessation
Drug: placebo
Drug: Varenicline Tartarate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Subjects With Four Week Continuous Quit Rate (CQR) [ Time Frame: Week 9 through Week 12 ] [ Designated as safety issue: No ]
    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:
  • Number of Subjects With Continuous Abstinence (CA) [ Time Frame: Week 9 through Week 24 and Week 52 ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With Long Term Quit Rate (LTQR) [ Time Frame: Week 24, Week 52 ] [ Designated as safety issue: No ]

    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.


  • Number of Subjects With 7-Day Point Prevalence of Abstinence [ Time Frame: Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With 4-Week Point Prevalence of Abstinence [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in First Second (FEV1) [ Time Frame: Baseline, Week 12, Week 52 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Clinical COPD Questionnaire (CCQ) [ Time Frame: Baseline, Week, 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    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.

  • Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period [ Time Frame: Day 1 through Day 21 ] [ Designated as safety issue: No ]
    Number of cigarettes smoked daily collected during the first 3 weeks of study after randomization using patient smoking diaries.

  • Change From Baseline in Inflammatory Biomarkers: C-Reactive Protein (CRP) and Fibrinogen Antigen [ Time Frame: Baseline, Week 12, Week 52 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Body Weight [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    Change from baseline calculated as mean at observation minus baseline value; body weight measured in kilograms (kg).


Enrollment: 504
Study Start Date: May 2006
Study Completion Date: April 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285012

  Show 32 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00285012     History of Changes
Other Study ID Numbers: A3051054
Study First Received: January 30, 2006
Results First Received: October 30, 2009
Last Updated: April 15, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
smoking cessation
smoking cessation in COPD

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Smoking
Lung Diseases, Obstructive
Respiratory Tract Diseases
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014