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

January 30, 2006
April 15, 2010
May 2006
July 2008   (final data collection date for primary outcome measure)
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).
The 4-week continuous quit rate for Weeks 9-12 with end-expiratory exhaled CO measurements â ¤10ppm, for the planned last 4 weeks of treatment.
Complete list of historical versions of study NCT00285012 on ClinicalTrials.gov Archive Site
  • 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).
Continuous abstinence from Week 9 through Week 52 and long-term quit rate through Week 52.
Not Provided
Not Provided
 
Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD).
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Smoking Cessation
  • 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)
  • 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
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Experimental: varenicline
    Intervention: Drug: Varenicline Tartarate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
504
April 2009
July 2008   (final data collection date for primary outcome measure)

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.
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Italy,   Spain
 
NCT00285012
A3051054
No
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP