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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
History of Changes
Results First Received: October 30, 2009  
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
Condition: Smoking Cessation
Interventions: Drug: placebo
Drug: Varenicline Tartarate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were current cigarette smokers 35 years of age or older with mild to moderate Chronic Obstructive Pulmonary Disease (COPD) as defined by Global Initiative for Chronic Obstructive Lung Diseases (GOLD) criteria.

Reporting Groups
  Description
Varenicline Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
Placebo Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.

Participant Flow for 2 periods

 Period 1:   Assigned to Study Treatment (Tx)
    Varenicline     Placebo  
STARTED     250     254  
COMPLETED     248     251  
NOT COMPLETED     2     3  
Unknown                 2                 3  

Period 2:   Received Study Tx
    Varenicline     Placebo  
STARTED     248     251  
Completed Tx (May Continue in Study)     207 [1]   193 [1]
Discontinued Tx (May Continue in Study)     41 [2]   58 [3]
COMPLETED     176 [4]   157 [4]
NOT COMPLETED     72     94  
Death                 2                 1  
Adverse Event                 5                 11  
Lack of Efficacy                 0                 3  
Lost to Follow-up                 29                 31  
Withdrawal by Subject                 31                 43  
Unknown                 5                 5  
[1] After treatment completion at Wk 12, subjects may continue in nontreatment follow-up phase
[2] Discontinued Tx=12 Adverse Event (AE); 10 Lost to follow up; 13 subject withdrawal; 6 other, unknown
[3] Discontinued Tx=14 AE;3 Lack of efficacy;10 Lost to follow up;25 subject withdrawal;6 other, unknown
[4] Completed study through nontreatment follow-up phase Week 13 to Week 52



  Baseline Characteristics
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Reporting Groups
  Description
Varenicline Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
Placebo Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
Total Total of all reporting groups

Baseline Measures
    Varenicline     Placebo     Total  
Number of Participants  
[units: participants]
 		  248     251     499  
Age  
[units: years]
Mean ± Standard Deviation 		  57.2  ± 9.1     57.1  ± 9.0     57.1  ± 9.1  
Gender  
[units: participants]
 		     
Female     93     95     188  
Male     155     156     311  



  Outcome Measures
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1.  Primary:   Number of Subjects With Four Week Continuous Quit Rate (CQR)   [ Time Frame: Week 9 through Week 12 ]
  Show Outcome Measure 1

2.  Secondary:   Number of Subjects With Continuous Abstinence (CA)   [ Time Frame: Week 9 through Week 24 and Week 52 ]
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3.  Secondary:   Number of Subjects With Long Term Quit Rate (LTQR)   [ Time Frame: Week 24, Week 52 ]
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4.  Secondary:   Number of Subjects With 7-Day Point Prevalence of Abstinence   [ Time Frame: Week 12, Week 24, Week 52 ]
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5.  Secondary:   Number of Subjects With 4-Week Point Prevalence of Abstinence   [ Time Frame: Week 52 ]
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6.  Secondary:   Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in First Second (FEV1)   [ Time Frame: Baseline, Week 12, Week 52 ]
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7.  Secondary:   Change From Baseline in Clinical COPD Questionnaire (CCQ)   [ Time Frame: Baseline, Week, 12, Week 24, Week 52 ]
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8.  Secondary:   Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period   [ Time Frame: Day 1 through Day 21 ]
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9.  Secondary:   Change From Baseline in Inflammatory Biomarkers: C-Reactive Protein (CRP) and Fibrinogen Antigen   [ Time Frame: Baseline, Week 12, Week 52 ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Baseline, Week 52 ]
  Show Outcome Measure 10


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:


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