Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00285012
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00285012
Recruitment Status : Completed
First Posted : February 1, 2006
Results First Posted : December 3, 2009
Last Update Posted : April 20, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE January 30, 2006
First Posted Date  ICMJE February 1, 2006
Results First Submitted Date  ICMJE October 30, 2009
Results First Posted Date  ICMJE December 3, 2009
Last Update Posted Date April 20, 2010
Study Start Date  ICMJE May 2006
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2010)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2006)
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.
Change History Complete list of historical versions of study NCT00285012 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2010)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2006)
Continuous abstinence from Week 9 through Week 52 and long-term quit rate through Week 52.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD).
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Experimental: varenicline
    Intervention: Drug: Varenicline Tartarate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2009)
504
Original Enrollment  ICMJE
 (submitted: January 30, 2006)
500
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00285012
Other Study ID Numbers  ICMJE A3051054
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2010

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